MASTER OF SCIENCE

IN

NURSING

OBSTETRIC AND

GYNAECOLOGICAL

NURSING
 “A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF CALENDULA
OINTMENT VERSUS ALOE VERA GEL ON EPISIOTOMY WOUND AMONG
POSTNATAL MOTHERS ADMITTED IN SELECTED HOSPITALS”.
By

MS. KOMAL PRABHAKAR PETKAR

A DISSERTATION
SUBMITTED TO

MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES, NASHIK

IN PARTIAL FULFILLMENT OF THE REQUIREMENT FOR THE
DEGREE OF
MASTER OF SCIENCE IN NURSING
OBSTETRIC AND GYNAECOLOGICAL NURSING
UNDER THE GUIDANCE OF
ASSO. PROFESSOR- MRS. UJWALA PARKER M.Sc(N)
COLLEGE OF NURSING WANLESS HOSPITAL,
MIRAJ-416410, SANGLI, MAHARASHTRA, INDIA.
 “A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF CALENDULA
OINTMENT VERSUS ALOE VERA GEL ON EPISIOTOMY WOUND AMONG
POSTNATAL MOTHERS ADMITTED IN SELECTED HOSPITALS”.

DISSERTATION

SUBMITTED TO

MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES, NASHIK

IN PARTIAL FULFILLMENT OF THE REQUIREMENT FOR THE
DEGREE OF
MASTER OF SCIENCE IN
NURSING
OBSTETRIC AND GYNAECOLOGICAL NURSING

2019-2021
NAME OF THE MRS. KOMAL PRABHAKAR PETKAR
CANDIDATE

NAME OF THE COLLEGE COLLEGE OF NURSING WANLESS

HOSPITAL, MIRAJ.

NAME OF THE GUIDE MRS. UJWALA R. PARKER

(ASSO. PROFFESOR)
COLLEGE OF NURSING WANLESS
HOSPITAL, MIRAJ.

NAME OF THE COURSE M.Sc Nursing

NAME OF THE OBSTETRIC & GYNAECOLOGICAL

SUBJECT/SPECIALITY NURSING

ACADEMIC YEAR 2019-2021

 TOPIC
“TO ASSESS THE
EFFECTIVENESS OF CALENDULA
OINTMENT VERSUS ALOE VERA
GEL ON EPISIOTOMY WOUND
AMONG POSTNATAL MOTHERS
ADMITTED IN SELECTED
HOSPITALS”.
DEDICATION
“All that I am or ever
hope to be, I owe to
my angel Mother.”
When God made Moms,
He gave me
the best One.
 ACKNOWLEDGEMENT

“Whatever goal you give to your subconscious mind, it will work night

& day to achieve it.”

At the beginning, I express my deep gratitude and praise to God almighty

whose grace and continuous blessings have given me strength and courage to

complete this study. Thankfulness finds something good in every circumstance.

Success of an individual is only possible when others support him or her. In

the course of research, the investigator has been fortunate enough to receive

enough help from various sources.

This research endeavour of mine is in partial fulfilment of Masters in nursing

which has enabled me to grow as a nursing professional in assimilating the skills,

attitude & knowledge specific to the conduct of enquiry in nursing.

It gives me great pleasure to thank with deep sense of gratitude to Mrs.

Sangita. M. Satwekar, Principal, College of Nursing. Wanless Hospital, Miraj for

giving me permission to conduct this study with guidance. She was very helpful

and guided me with her expert advice in the topic of my study.

I express my heart full gratitude towards Mr. Samual E. Fernandis, Vice

principal, College of Nursing. Wanless Hospital, Miraj for his constant guidance

and support during the study.

 I wish to express my deep sense of gratitude and respect my guide Mrs.

Ujawala R. Parker, Asso. Professor, Head of the department Obstetric and

Gynaecological nursing, College of Nursing Wanless Hospital, Miraj for

encouraging me to select this topic and for her valuable and constructive

suggestions during the planning and development of the research work and her

guidance & support during the study.

I am highly obligated to Dr. Nathaneil S. Sase, Director Wanless Hospital,

Miraj, for their cooperation and Authority of Somshekhar Hospital and Dorle

Hospital, Miraj, for granting the permission to conduct the research study in their

hospital.

I am grateful to Mrs. Hilda Kadam, Asso. Prof, As a coordinator for her

valuable support and immense help in carrying out the research study

I am very grateful and thankful to Mrs. Hilda W. Kadam Asso. Prof, Mr.

Bhalchandra Awale Asso. Prof, Mrs. Suman M. Pawar Asso. Prof, Mrs. U. R.

Parker Asso Prof, Ms. Varsha V. Chopade Lecturer, Ms. Jessey J. Jacob. Lecturer

and Mr. Prashant Malap Lecturer, Mrs. Jyoti Desai Lecture, Mrs. Leeja Sabu,

Lecturer, Mrs. Kavita Pandhre Lecturer College of Nursing Wanless Hospital Miraj,

for their kind support during the course of the study.

 My gratitude is also extended to the statistician Dr. Mr. Satish R. Kakade.

Asso. Prof. and Mr. Vijay More Asst. Prof. for his necessary guidance & statistical

analysis of the data.

I am very thankful to English editor Mrs. Sangita Oak, M.A. M.Ed (English),

for extending their well wishes and support.

I wish to express my heartfelt thanks to the helpfull Office Staff Mrs.

Sushma Chopade, Mrs. Mary Lucas and Mrs. Neha Bhore, librarians Mrs. R. A.

Jawanjal and Mrs. Shilpa D. Sambargikar, Housekeeping staff College of Nursing

Wanless Hospital Miraj, for providing important resources necessary for my

research study. I sincerely acknowledge to all experts for their valuable suggestion

in validating the tool and content.

My parents are my heroes, where no one can be substituted. I am very

much thankful to my Father Mr. Prabhakar Petkar, Mother Mrs. Shobha Petkar

for their constant encouragement without whom this study would have been

impossible. I special thanks to my Mama Dr. Rajesh Darade and My Mami Dr.

Mrs. Varsha R. Darade, who is my real life role model who shaped me, during my

difficulties & because of their support only today I am here.

Most especially, I am grateful to my Husband Mr. Ganesh Bondge, my

Mother in law Mrs. Savita Bondge and Father in law Mr. Anant Bondge who

always supported me in this journey. After marriage they supported me a lot

without their support and belief on me it was not possible to complete my study

successfully.

I render my deep of gratitude to all my classmates Ms. Krupapallavi, Ms.

Silvhiya, Ms Dipali, Ms. Salomi, Mr. Jay, Mr. Akash, Mr. Ajay and colleagues for

their constant help throughout the study.

Thanks to all others who have helped me directly or indirectly towards the

preparation of this dissertation.

Ms. Komal Petkar

 TABLE OF CONTENTS

SR. NO CONTENTS PAGE NO.

CHAPTER INTRODUCTION
I
1. Introduction 1-3

2. Background of the Study 3-4

3. Need for the study 4-6

4. Title of the study 7

5. Problem Statement 7

6. Objectives of the study 7

7. Operational definitions 7-9

8. Scope of the study 9-10

9. Assumption 10

10. Hypothesis 10

11. Research Question 10

12. Ethical aspects 11

 13. Conceptual Framework 11-13

14. Summary 14

CHAPTER REVIEW OF RELATED

II
LITERATURE

1. Introduction 16

2. Studies related to prevalence of 17-20

episiotomy.
3. Studies related to effectiveness 20-23
of calendula ointment on wound
healing/episiotomy wound
4. Studies related to effectiveness 23-29
of aloe vera gel on wound
healing/episiotomy wound
5. Summary 30

6. Conclusion 30

CHAPTER RESEARCH METHODOLOGY

III
1. Introduction 32

2. Research Approach 32

3. Research Design 33-34

4. Variables of the study 34

5. Setting of the study 34

6. Population 34

7. Identification of target and 35

accessible population

8. Sample 35

9. Sampling technique 35

10. Sample size 36

11. Criteria for selection of sample 37

12. Development and preparation of 37-38

tool

13. Validity, reliability and pilot study 39-40

14. Feasibility of the study 40

15. Data collection procedure 41-42

16. Plan for data analysis 42-43

17. Summary 44
CHAPTER ANALYSIS AND
IV
INTERPRETATION

1. Introduction 46

2. Objectives of the study 46-47

3. Research question 47

4. Hypothesis 47

5. Organization of findings 47-58

6. Summary 58

CHAPTER FINDINGS, DISCUSSION,

V
CONCLUSION, IMPLICATIONS

AND RECOMMENDATIONS

1. Introduction 60

2. Brief summary of the study 60-65

3. Major Findings of the study 65-67

4. Discussion 68-70

5. Conclusion 70-71
6. Nursing Implications 71-73

7. Limitations 73

8. Recommendations 73

9. Summary 73

BIBLIOGRAPHY 75-80

ANNEXURES 82-108

ABSTRACT 110-111
 LIST OF TABLES

TABLE TITLE PAGE

NO NO

1. Analysis of demographic data of postnatal mothers in 48

terms of frequency and percentage.

2. 55
Pre-test and post-test evaluation of effectiveness of

Calendula ointment (Group A) on episiotomy wound.

3. Pre-test and post-test evaluation of effectiveness of 56

Aloe vera gel (Group B) on episiotomy wound

4. Post test assessment of effectiveness of calendula 57

ointment versus aloe vera on episiotomy wound.

 LIST OF GRAPHS

GRAPH PAGE

NO TITLE NO

1. Cluster bar graph showing percentage distribution of 49

postnatal mothers according to age.

2. Cluster pyramid graph showing percentage distribution of 50

postnatal mothers according to education.

3. Bar graph showing the percentage distribution of postnatal 51

mothers according to type of work.

4. Pie graph showing the distribution of postnatal mothers 52

according to parity.

5. Cylindrical Graph showing pre-test and post-test 53

assessment of episiotomy wound by REEDA in

experimental group ‘A’ (calendula ointment).

6. Cylindrical graph showing pre-test and post-test assessment 54

of episiotomy wound by REEDA in experimental group ‘B’

(aloe vera gel).

 LIST OF FIGURES

FIGURE NO TITLE PAGE NO

1. The conceptual framework is applied and 13

adopted by ‘Ludwig Von Bertalanffy’

2. Schematic representation of research 43

methodology
 LIST OF ANNEXURES

ANNEXURE TITLE PAGE NO

1. Institutional ethical committee approval certificate 83

2. Request letter for permission to conduct the 84-85

study

3. Letter requesting expert opinion to establish 86

content validity of the tool by principal

4. Letter requesting expert opinion to establish 87

content validity of the research tool by student

5. Certificate of validation of research tool 88

6. Criteria checklist for evaluation of tool requesting 90

suggestion and opinions from experts
7. Certificate of English editing 91

8. Consent form English 92

9. Consent form Marathi 93

10. Research Tool 96-100

11. Procedure 101-102

12. Master data sheet 104-107

13. Abbreviations 108

14. Certificate of guide 112

15. Authorship declaration 113

 CHAPTER-I

INTRODUCTION
 CHAPTER-I

INTRODUCTION

“Being a mother is learning about strengths you didn’t know you had....and

dealing with fears you didn’t know existed.”

- LINDA WOOTEN

Pregnancy is a creative and productive period in the life of women and the

process of delivery purely depends on the mother and the fetus, where the mother plays

a major role in delivering the fetus. In order to deliver a baby safely the birth canal plays

a vital role. The structure of birth canal varies from individual to individual; some may

have thick vaginal tissues which may not dilate even after the application of fetal axis

pressure. Hence, the incision is made in perineum to create a passage sufficiently

during second stage of labour, so that the baby can be more easily delivered.1

According to Joan (2006) the term “Episiotomy” refers to the intentional incision

of vaginal opening to hasten delivery or to avoid or decrease potential tearing.

Episiotomy is the most common procedure performed in modern day obstetrics. In

today’s statistics it is estimated that as many as 65% to 80% of mothers who deliver

vaginally will have an episiotomy.1

A survey conducted among eleven developing countries including India across

the Global Network for women’s and children’s Health Research sites (2003) reported

over 90% episiotomy rates among nullipara though overall rate was about 40%. Among

1, 20,243 vaginal deliveries, episiotomy was performed in 63.4 percent (n=76,305)

cases. Nullipararous women were 8.8 times more likely to undergo episiotomy than

multiparous women.2

1
 The process of wound healing from episiotomy continues to be a problem for

many postnatal mothers. To overcome this problem, Salcido and Richard in 2004

emphasized that, when the cost of medical treatment and care is soaring, alternative

and complementary medicine came in existence to cover a wide variety of healing

philosophical approaches which has increased in healthcare industry today. Hence, the

herbal care of mothers with episiotomy can be provided if the nurse and midwives

realize the relevance of their case and potential impact of the advocated procedure in

wound healing.1

Calendula is the other herb which is used for quickening the wound healing

which has anti-inflammatory, anti-virus, antimicrobial and antifungal activity, anti-cancer,

antioxidant and healing function. Flavonoids and saponins in calendula prevent from

releasing of harmful and histamine enzymes which cause sensitivity and inflammation

and heal the redness and pain and inhibits plasma discretion to the tissues by

decreasing the capillary permeability. Meanwhile, it reduces the immigration of white

blood cells to inflamed area. Its anti-inflammatory effects are due to triterpenoids. In a

study on animals, calendula stimulates granulation and increases glycoprotein and

collagen.3

Aloe vera is a plant that belongs to Liliaceae family that grows easily in hot and

arid regions. The existing mucilage tissue at the center of leaves in this plant that is also

so-called aloe gel is used for various cosmetics and medical applications.3

Aloe vera has healing, anti-inflammation, analgesic, anti-virus, anti-bacteria,

antifungal, purgative, anti-itching and moisturizing properties. Aloe vera including

collagen increases the tissue granules and is effective in wound healing due to its anti-

inflammatory properties. Its anti-inflammatory effects are due to the availability of

2
Salicylic acid which inhibits the formation of Bradykinin and Histamine and due to

oxidation of arachidonic acid which inhibits Prostaglandin synthesis.4

BACKGROUND OF THE STUDY:-

“Life doesn’t come with a manual. It comes with a mother”.

Pregnancy and childbirth are special events in a woman’s lives. Mothers suffer

much distress after child birth due to painful delivery that affect the perineum. Perineal

pain is most commonly associated with child birth by vaginal delivery. Episiotomy is a

small surgical procedure performed during the second stage of labour, the first

performance of episiotomy was done in 1742. Episiotomy is characterized by greater

blood loss in conjunction with delivery, and there is a risk of improper wound healing

and increased pain during early puerperium.5

Episiotomy rates vary widely worldwide, depending on the procedure is used

restrictively/routinely. The worldwide episiotomy rates of 27%-54% are nulliparous and

6% are multiparous women (WHO 2003). In India the birth rate is very high, 56% of

women had an episiotomy compared to the 46% of white women.6

Midwives have a very important role to play in the care of perineal wounds

following childbirth. Various intervention are found to reduce episiotomy pain and

enhance the healing process which include administration of analgesics, cleanliness,

topical application by dry heat and moist heat, sitz bath performance of kegal exercise,

perineal care and complementary therapies. It is important that midwives recognize the

need for research-based practice in episiotomy care.5

3
 Calendula is made from: the Garden marigols (Calendula officinalis). It is one of

the most popular homeopathic medicines worldwide. It has wound healing properties

due to the presence of essential oils, saponins, flavonoids & alkaloids. These

compounds have been shown to promote healing. Homeopathic preparations of the

flower have been used for generations to speed the healing process.7

In order to provide the effectiveness in episiotomy wound healing, there are

various treatment modalities that have been commonly practiced which include hot and

cold application, sitz bath, infra-red therapy and application of procaine spirit. To

compliment the effect in wound healing, alternative therapies are now widely used in

practice. Aroma therapies like application of lavender oil, rose oil, grape fruit and orange

and herbal therapies.1

The gel extracted from “Aloe vera” (a natural herbal plant) which is fresh, when

applied on the episiotomy wound heals at faster rate due to the presence of 200 active

components such as vitamins, enzymes, minerals, sugars, fatty acids and aminoacids.

Hence, application of aloe vera extract plays a good remedy for the mothers in progress

of wound healing with shortest time possible, minimal pain and increased comfort.

Therefore, the aim of treating a wound by the researcher should either shorten the time

required for healing or to minimize the undesired consequences.1

NEED FOR THE STUDY

According to WHO the episiotomy is performed in an area that is abundant with

bacteria, if the wounds are untreated the infection may extend deeper into tissues and

make it difficult to treat with antibiotics alone. So, the care of episiotomy wound begins

immediately after delivery and should include the combination of local wound care and

pain management.1

4
 Many actions have been proposed for quickening the episiotomy wound healing

such as using disinfectant techniques during healing, prevention from unnecessary

damage in cutting area, observing perineum health, keeping the wound area dry, using

localized methods such as cold or hot water, cetrimide and betadine, Kegel exercises,

using herbal extracts pads such as lavender, chamomile, fecundity and calendula, etc.3

At now, the researchers pay attention to using cheap, effective, proper methods

which are accessible in health centers apart from hospitals and meanwhile, being

acceptable by postpartum women. In this regard, complementary medicine including

traditional and herbal medicine, homeopathy, and Aromatherapy solutions has special

place in promoting the care quality after delivery. Nowadays, using non-traditional or

comprehensive treatment methods are increasing and according to world health

organization, herbal medicine is part of the complementary medicine which is accepted

by many people of the society and 40% of common drugs are derived from plants and

natural resources.3

The smallness of episiotomy cut brings us to assume that this operation will not

cause problem to the mothers, though this area participates in more ordinary activities

such as sitting, walking, standing, squatting and urinating due to the availability of many

muscles in the pelvic floor and causes discomfort for postpartum women. About

studying the healing effect of Aloe vera gel for treating pressure ulcer indicated that the

time needed for reducing the redness, inflammation, discharge and the time needed for

full wound closure were significant while using Aloe vera gel.3

A descriptive study was conducted to assess the clinical benefits of using

Calendula officinalis hydroglycolic extract for the topical treatment of diabetic foot ulcers

in Brazil. 109 patients were selected for data collection. Patients provided demographic

5
and diabetes-related information and were evaluated biweekly for 30 weeks or until

healing. Interventions given twice a day with 25 ml of sterile physiological saline solution

after which 0.018mL/cm2of wound area calendula officinalis extract was sprayed on the

wound and covered with saline-moistened, sterile, nonadherent gauze and bandages.

Tool used for data collection is 10-point rating scale. The result showed that there are

no adverse events with the calendula officinalis hydroglycolic extract were observed

during the treatment. The study concluded that the use of Calendula officinalis extract

was associated with high percentage (78%) of diabetic foot ulcer was healed.8

A Quasi experimental study was conducted to assess the effect of aloe vera

extract on episiotomy wound among postnatal mothers in Krishnagiri, Tamilnadu. Quasi

experimental one group post-test design was used in this study. 46 postnatal mothers

were selected using convenient sampling technique. Tools used for this study were

modified Southampton wound healing scale & modified Bates Jensen wound score

continuum. Intervention was given two times a day for a period of 5 days. The result

showed that tere is a significant effect in progress of wound healing. The study

concluded that the aloe vera extract is found to be effective in faster wound healing.1

Now-a-days most of the mothers are undergoing episiotomy, so there will be

need of proper episiotomy care. Hence the researcher felt application of calendula

ointment & aloe vera gel will be effective because of its easy availability, cost

effectiveness & there are no any side effects in promoting wound healing. Hence the

researcher selected the present study to compare the effectiveness of calendula

ointment & aloe vera gel on episiotomy wound among postnatal mothers.

6
TITLE

“TO ASSESS THE EFFECTIVENESS OF CALENDULA OINTMENT VERSUS ALOE

VERA GEL ON EPISIOTOMY WOUND AMONG POSTNATAL MOTHERS ADMITTED

IN SELECTED HOSPITALS”.

PROBLEM STATEMENT

“A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF CALENDULA

OINTMENT VERSUS ALOE VERA GEL ON EPISIOTOMY WOUND AMONG

POSTNATAL MOTHERS ADMITTED IN SELECTED HOSPITALS”.

OBJECTIVES

1. To assess the episiotomy wound among postnatal mothers in both the

Experimental groups.

2. To assess the effectiveness of calendula ointment on episiotomy wound among

postnatal mothers in Experimental Group A.

3. To assess the effectiveness of aloe vera gel on episiotomy wound among

postnatal mothers in Experimental Group B.

4. To compare the effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound among postnatal mothers in both the Experimental groups.

OPERATIONAL DEFINITIONS

1. EFFECTIVENESS: - The extent to which something succeeds. A result produced

by agent, action or force. -------(According to Baillie’re’s Nurses Dictionary)

7
 In this study it refers to the extent to which the calendula ointment and aloe vera

gel application has produced the desired effect in promoting the episiotomy

wound healing.

2. CALENDULA OINTMENT: - Calendula officilanis, is a marigold plant that has

historically been used for a host of different ailments, mainly those affecting the

skin such as in the healing of wounds.

------ (According to Ayurveda Medical Dictionary. P.V.Ranganayakulu.)

In this study calendula ointment is ayurvedic medicine prepared commercially

each gm contains Calendula eq. to Extract-10% & Jatyadi tail- 10% is used.

There will be application of calendula ointment on episiotomy wound and the

amount is 3 ml, thrice a day for 3 day.

3. ALOE VERA GEL: - A preparation of leaf pulp from the parenchymal tissue of

the plant Aloe vera. Aloe vera gel contains carbohydrate polymers, such as

glucomannans or pectic acid, and various vitamins and essential amino acids.

------ (According to Dictionary of Ayurveda. Ravindra Sharma.)

In this study aloe vera gel is ayurvedic medicine prepared commercially each 5

gm contains Aloe barbadensis- 90% remaining 10% is vitamin E & Sugandhit

dravya. There will be application of aloe vera gel on episiotomy wound and the

amount is 3 ml, thrice a day for 3 days.

4. EPISIOTOMY WOUND: - An incision made in the perineum when it will not

stretch sufficiently during the second stage of labour. A perineal tear or laceration

often forms on its own during a vaginal birth.

8
 ------ (According to Textbook of Obstetrics & gynaecology.Jacob A.)

In this study, it refers to planned surgical incision made on lateral & posterior

vaginal wall during vaginal delivery which has been sutured & manifested as loss

of tissue & skin integrity, pain & discomfort. The regeneration of tissue integrity of

perineum which is assessed by using REEDA scale (redness, edema,

ecchymosis, discharge, approximation).

5. POSTNATAL MOTHERS: - Postnatal is the period beginning immediately after

the birth of a child & extending for about six weeks.

------- (According to Pocket Medical Dictionary. Nancy Roper.)

In this study, it refers to women who have normal or instrumental vaginal delivery

with episiotomy, admitted in selected hospitals.

SCOPE OF THE STUDY

An episiotomy is an incision made to make the delivery of baby easier for

mothers. Episiotomy is a common surgical procedure performed during the second

stage of labour. This research study will be helpful in the clinical setup as nurses are the

ones who will be taking care of mother in her postnatal period. Episiotomy wound is

common in normal vaginal delivery and causes more discomfort for mother. Early

wound healing is essential factor in postnatal period. Calendula is the other herb which

is used for quickening the wound healing which has anti-inflammatory, anti-virus,

antimicrobial and antifungal activity, anti-cancer, antioxidant and healing function..

Aloe vera has healing, anti-inflammation, analgesic, anti-virus, anti-bacteria,

antifungal, purgative, anti-itching and moisturizing properties. Aloe vera including

9
collagen increases the tissue granules and is effective in wound healing due to its anti-

inflammatory properties. The expense can be reduced by calendula ointment and aloe

vera gel application for episiotomy wound healing. It will be helpful for mothers from all

economical groups. Calendula ointment and aloe vera gel both are easily available in

medical shop. It is not having any kind of side effects. As it is natural products patient

and her family will trust and co-operate easily. Application of calendula ointment and

aloe vera gel fasters wound healing and reduces pain as compare to other medicinal

products.

ASSUMPTIONS

1. Episiotomy wound produces discomfort among postnatal mothers.

2. Calendula ointment & aloe vera gel application may have effect on episiotomy

wound in postnatal mothers.

HYPOTHESIS

H0: - There will be no significant difference between the effectiveness of calendula

ointment and aloe vera gel on episiotomy wound in both experimental groups.

H1:- There will be significant difference between the effectiveness of calendula ointment

and aloe vera gel on episiotomy wound in both experimental groups.

RESEARCH QUESTION

Does calendula ointment or aloe vera gel have effect on episiotomy wound

among postnatal mothers admitted in selected hospitals?

10
ETHICAL ASPECTS

The topic of the study was approved by the institutional ethical committee. The

permission for conducting the study was obtained from the administrative department of

selected hospitals. The nature of the study, aims and objectives were explained to the

subjects after assuring that their information would be kept confidential and used for

research purpose only.

CONCEPTUAL FRAMEWORK

A conceptual framework is a theoretical approach to study the problems that are

scientifically based which emphasizes selection, arrangement & classification of its

concepts. Selecting a nursing conceptual framework helps the researcher to identify

problem that are of significant to the discipline of nursing.

The study was based on the concept that application of calendula ointment versus

aloevera gel on wound among postnatal mothers receiving episiotomy. The investigator

adopted the General System Theory introduced by Ludwig Von Bertalanffy (1968).

According to this theory, a system is a group of elements that interact with one another

in order to achieve the goal. It has 5 factors as follows.

1. Input:

It consists of information, material, or energy that enters the system.

In this study, it refers to postnatal mothers who have undergone normal and

instrumental vaginal delivery with episiotomy wound. The input includes demographic

variables such as age, education, type of work & parity of postnatal mothers. Pre

assessment of episiotomy wound is done with Davidson’s REEDA scale.

11
2. Process:

It is the action needed to accomplish the desired tasks, to achieve the desire

output. In this study, it refers to application of 3ml of calendula ointment to group A and

3ml of Aloe vera gel to group B on episiotomy wound, three times a day for three days.

3. Output:

It refers to the energy, matter or information disposed of by the system as a

result of its process. In this study, it refers to post-test assessment of episiotomy wound

healing using REEDA scale.

4. Feedback:

Feedback is a process whereby output of the system is redirected as part of the

input to the same system. Feedback is not included in this study.

5. Environment:

Individual environment is a consent that influences the system. In this study

environment refers to the postnatal wards of selected hospitals.

12
 ENVIRONMENT

INPUT PROCESS OUTPUT

Pos-test
Demographic
Assessment of episiotomy
variables Experimental
Experimental wound with REEDA scale
Age, Education, Group B
Type of work & Group A
Parity Application of 3
Application of 3
ml of Aloe vera Experimental
Experimental
ml of Calendula Group B
gel thrice a day Group A
ointment thrice
for 3 days
Experimental Experimental a day for 3 days Improvement
Improvement
Group A Group B in episiotomy
in episiotomy
wound
wound
healing i. e.
healing i. e.
Healed- 25%
Healed- 35%
Pre-test
Assessment of episiotomy Moderately
Moderately
FEEDBACK healed- 75%
wound with REEDA scale healed- 65%

SCHEMATIC REPRESENTATION OF CONCEPTUAL FRAMEWORK BASED ON LUDWIG VON BERTALANFFY (1968)

13
SUMMARY

This chapter deals with the background of the study, scope of the study,

statement of the problem, objectives, operational definitions, hypothesis, assumptions

and a related conceptual framework which was applicable for the study.

14
CHAPTER-II

REVIEW OF

LITERATURE

15
 CHAPTER-II

REVIEW OF LITERATURE

INTRODUCTION:-

Review of literature is a key step of a research process. Nursing research is

considered as continuing process in which knowledge gained from earlier studies is an

integral part of research.

A literature review is a body of text that aims to review the critical points of

knowledge on a particular topic of research.9

The investigator carried out an extensive review of literature on the research topic

in order to gain insight into the problem and to collect maximum relevant information for

building up the study in a scientific manner so as to achieve the desired results.

Review of published and unpublished research and non-research literature is an

integral component of any scientific research. The literature for the review was selected

from published journals, articles, textbooks, and various websites.

In this study review of literature is organised under the following headings

1. Studies related to prevalence of episiotomy

2. Studies related to effectiveness of calendula ointment on wound

healing/episiotomy wound

3. Studies related to effectiveness of aloe vera gel on wound

healing/episiotomy wound

16
 1) Studies related to prevalence of episiotomy

A descriptive cross-sectional study was conducted to assess the

prevalence and factors associated with episiotomy in Shahroud City, Iran. 978

Participants were selected by census to collect the data. Tool used for this study

is structured questionnaires. The result showed that overall prevalence of intact

perineal was 34.7%. In the final logistic regression analysis among significant

variables with P<0.1 in univariate analysis, parity, use of oxytocin, first minute

apgar score & infants head circumference with P,00001 & birth spacing with

P=0.043 were considered predictors of episiotomy. The study concluded that the

overall rate of episiotomy in this study was 41.5%, which is much higher than the

standards set by the World Health Organization (WHO).10

A retrospective cross-sectional study conducted to assess the prevalence and

predictors of episiotomy among women at first birth in Enugu, Nigeria. 662 nulliparous

women were selected to collect the data. Tool used in this study is records of women

that had their first delivery at the University of Nigeria Teaching Hospital (UNTH) Enugu,

over a 5-year of April 2004 to March 2009. The result showed that the prevalence of

episiotomy in the study was 62.1% (411/662). The episiotomy rate for booked women

(65.6%, 376/573) was significantly higher than that of unbooked women (39.3%, 35/89)

(prevalence ratio=1.67).The study concluded that the Prevalence of episiotomy among

women that had their first births in the UNTH, Enugu was high.11

17
 A retrospective study was conducted to assess the prevalence of episiotomy in

Turkey. There is involvement of 3 state hospitals located in 3 cities in the Central

Anatolia region of Turkey. 8587 women were selected for data collection. The data of the

study were collected by analyzing birth records in archive records. The result showed

that the average age of the women was 26.16 ± 5.9 years, the average number of

deliveries was 2.19 ± 1.2, and 52.0% of the women who gave birth via vaginal delivery

underwent episiotomy. The rate of episiotomy was found to be 93.3% in primipara

women and 30.2% in multipara women. The study concluded that the rate of episiotomy

was observed to be high, especially in primipara women.12

A study was conducted to assess the pattern of episiotomy & its immediate

complications among vaginal deliveries in 18 tertiary care hospitals in India.18 tertiary

care hospitals were included to collect data. Total population was 1, 20,243. The annual

deliveries were more than 10,000 in seven hospitals; between 5000 to 10,000 in five &

1000 to 5000 in remaining sites. Tool used to collect the data is fisher’s exact test &Odds

ratio. The result showed that among 1, 20,243 vaginal deliveries, episiotomy was

performed in 63.4% (n=76,305) cases. Nulliparous women were 8.8 times more likely to

undergo episiotomy than multiparous women. The study concluded that significantly

lower rates of third or fourth degree perineal tear were seen among nulliparous women

undergoing episiotomy.13

A cross-sectional study was conducted to assess the predictors of routine

episiotomy in primigravida women in Oman. Data were collected from perceptions of 269

obstetricians, midwifes& nurses working in 11 different hospitals in five governorates

using cluster sampling technique. Data collected over a period of 4 months. The result

18
showed that rate of episiotomy was 66%. In terms of performing routine episiotomies

(p<0.05).The study concluded that the rate of episiotomy was higher than other similar

contexts.14

A cross-sectional study was conducted to assess the Prevalence and factors

associated with episiotomy practice among primiparous women in mulago national

referral hospital, Uganda. Data were collected from 249 participants. Data collected over

a period of 2 months. Tool used for data collection were questionnaire. The result

showed that the prevalence of episiotomy was 73% (181/249) (CI 67-78). Episiotomy

was also found to be associated with gestational age above 37 weeks OR=1.8 (CI; 1.28-

2.40 p<0.001). The study concluded that the prevalence of episiotomy among

primiparous was high.15

A cross sectional study was conducted to assess the Prevalence & risk factors of

episiotomy & perineal tear in the maternity teaching hospital of Erbil city, Iraq. Data were

collected from 1500 mothers. Data collected for the month of may 2015. Chi square test

of association & binary logistic regression were used to interpret the data. The result

showed that the prevalence of episiotomy was found to be 73.9%. The study concluded

that the prevalence of episiotomy was much higher compared to the World Health

Organization recommendation which is 10%.16

A cross sectional study was conducted to assess the Prevalence of episiotomy &

factors associated with practice of episiotomy at St. Paul’s hospital, Addis Ababa,

Ethiopia. Data were collected from 405 participants. Data collected from Feb 1, 2016 to

July 1, 2016. The result showed that the prevalence of episiotomy was 65.4%. The study

19
concluded that the prevalence of episiotomy was higher than the findings in other studies

in Ethiopia & the WHO’s recommendation of 5-10%.17

A descriptive, cross sectional study was conducted to assess the frequency of

episiotomy & complications in the obstetrics service in Colombia. Data were collected

from 197 participants. Data collected during the 1st semester of 2016. The result showed

that the frequency with episiotomy was performed was 30.45%. The study concluded

that episiotomy is performed more frequently in this institution than recommended by the

WHO.18

2) Studies related to effectiveness of calendula ointment on wound

healing/episiotomy wound

A study was conducted to assess the effect of calendula ointment in wound

healing of episiotomy among primiparous women admitted in Lolagar Hospital, Tehran.

74 primiparous women were selected by randomized control trial method. 37 women

undergone the application of calendula ointment & control group consisted of 37 women

that have hospital routine care. Intervention was given for 5 days. Tools used for data

collection were questionnaire and REEDA scale. The result showed that The REEDA

score was significantly lower in the experimental group (Calendula ointment) 5 days after

episiotomy (p=0.001). The study concluded that Calendula ointment can be used in

episiotomy wound care instead of Povidon Iodine solution because this compound has

anti- inflammatory and antimicrobial properties that were more effective than Povidon

Iodine in wound pain relief.19

20
 A study was conducted to assess the impact of calendula ointment on cesarean

wound healing in Tehran. 72 primiparous females were selected. They were randomly

categorized into two groups of experimental and control groups. The female in

experimental group used calendula ointment every 12 hourly & control group used

hospital routine. Intervention was given for 10 days. Wound healing was assessed on the

3rd, 6th& 9th days of post cesarean. Tool used for data collection was REEDA scale. The

result showed that the age of patients in the two groups did not differ significantly (27/17

± 4/72, 28/97 ± 4/99 years, respectively; P = 0/276). The study concluded that Using

calendula ointment considerably increases the speed of cesarean wound healing so it

can be used for quickening the cesarean healing.20

A study was conducted to compare the therapeutic efficacies of Aloe vera cream

& Calendula officinalis ointment on Diaper Dermatitis in children in Tehran. 66 children’s

were selected for data collection. 32 patients receiving application of aloe vera cream &

34 receiving application of calendula ointment. Infants were receiving these intervention

3 times a day for 10 days. Tool used for data collection was 5-point scale. The result

showed that improvement in the severity of DD was observed in both treatment groups

(P < 0.001), patients receiving Calendula ointment had significantly fewer rash sites

compared to aloe group (P = 0.001). The study concluded that topical aloe and particular

Calendula could serve as safe and effective treatment for the treatment of diaper

dermatitis in children.21

A study was conducted to compare the effectiveness of Calendula officinalis &

Trolamine for the prevention of acute dermatitis during irradiation for breast cancer in

France. 254 patients were selected for data collection. 128 patients were receiving

21
trolamine application & 126 patients was receiving calendula application. Intervention

was given twice a day or more depending on the occurrence of dermatitis & pain 5

sessions per week at the onset of radiotherapy. Tool used for data collection is 10-cm

visual analog scale. The result showed that the occurrence of acute dermatitis of grade 2

or higher was significantly lower (41% v 63%; P <.001) with the use of calendula than

with trolamine. The study concluded that calendula is highly effective for the prevention

of acute dermatitis of grade 2 or higher and should be proposed for patients undergoing

postoperative irradiation for breast cancer.22

A study was conducted to assess the effectiveness of pressure ulcer healing with

Plenusdermax Calendula officinalis extract in Brazil. 41 patients were selected with a

diagnosis of pressure ulcer. Intervention was given twice a day for 30 weeks. Patient’s

was assessed every 2 weeks for 30 weeks. Tool used for data collection was pressure

ulcer scale for healing. The result showed that the proportions of patients who were

completely healed after 15 and 30 weeks of treatment were 63% and 88%, respectively,

and the mean healing time was 12.5±7.8 weeks. No adverse events were observed

during treatment. The study concluded that C. officinalis Plenusde-rmax is a safe

treatment that promotes healing of pressure ulcers.23

A study was conducted to assess the results of the clinical examination of an

ointment with marigold (calendula officinalis) extract in the treatment of venous leg ulcers

in Serbia. 34 patients were selected with venous leg ulcers. In experimental group

intervention was given on 21 patients twice a day for 3 weeks. Control group consisted

of 13 patients, saline solution dressing was applied to ulcers for 3 weeks. The result

showed that in the experimental group the total surface of all the ulcers at the beginning

22
of the therapy was 67, 544 mm2. After 3rd week the total surface of all the ulcers was 39,

373 mm2. In the control group the total surface of all the ulcers at the beginning of the

therapy was 69, 722 mm2. After 3rd week the total surface of all the ulcers was 58, 743

mm2. The study concluded that there was a statistically significant acceleration of wound

healing in the experimental group.24

A study was conducted to assess the effect of calendula in healing of extraction

wounds in children in Jammu. 58 children’s were selected who required extractions of

deciduous teeth. In experimental group intervention was given on 27 children’s for 10

days. Control group consisted of 31 children’s; a cotton pack with a few drops of normal

saline was placed on socket. The children were evaluated on 3rd, 7th & 10th day post-

operatively. The result showed that 45% children from control group complained of

postoperative pain, whereas only 33% from the calendula group had post-operative pain.

The difference was found to be statistically significant (Chi square: 8.51, p=0.014). The

study concluded that topical application of calendula tincture caused significantly faster

healing after extraction & less post-operative pain in children.25

3) Studies related to effectiveness of aloe vera gel on wound

healing/episiotomy wound

An experimental study was conducted to evaluate the effectiveness of aloe vera

gel application on episiotomy wound healing among mothers in early puerperal period in

jaypur.60 early puerperal mothers(30 for experimental group & 30 for control group) were

selected for the study using purposive sampling technique. The early puerperal mothers

23
in experimental group receive aloe vera gel application & early puerperal mothers in

control group receive hospital routine care on episiotomy. Tools used foe data collection

was universal pain assessment scale & REEDA scale. 3 days of intervention was given

in both experimental & control group. The result showed that in experimental group the

mean post-test (4.9) was lower than mean pre-test (7.1) which showed that there was

significant difference between the mean pre-test and mean post-test of experimental

group whereas the mean in experimental group (5.03) was lower than mean in control

group (6.5). Calculated p value is .000045 (P<0.05) which showed the significant

difference between control group episiotomy wound healing and experimental group

episiotomy wound healing. The study concluded that aloe vera gel application was one

of the important and effective intervention in improving episiotomy wound healing in early

puerperal mothers.26

A study was conducted to assess the effectiveness of aloe vera gel versus

lavender oil on episiotomy wound among postnatal mothers in Mangalore. Pre-test post-

test design was used for this study in Mangalore. 40 mothers were selected using non-

probability sampling technique (twenty mothers in aloe vera gel group & twenty mothers

in lavender oil group). Intervention was given for two days. Tools used for data collection

was REEDA scale & universal pain assessment scale. The result showed that the

computed ‘t’ value of wound healing (0.623) was lesser than table value (t=1.96, p<0.05)

and ‘t’ value of pain (2.307) was greater than the table value (1.96) (t=1.96, p<0.05).

Pain score in aloe vera gel (3.8 ± 1.02) was lower than mean posttest pain score in

lavender oil group (4.55 ± 0.97). The study concluded that aloe vera gel is effective in

reducing episiotomy wound pain than lavender oil among postnatal mothers.27

24
 A study was conducted to compare the effectiveness of aloe vera gel dressing

and conventional dressing in chronic wounds in Dr. D. Y. Patil Medical College and

Hospital, Pune.50 samples was selected (Group A and Group B, 25 each). For Group A

Patients (patients receiving Aloe Vera gel therapy). For Group B patients (control group),

normal saline & providone iodine solution. Dressing was done twice a day. Tool used for

data collection was a sterile transparent A4 size sheet and a fine tipped permanent black

marker, the two largest perpendicular diameters of the ulcer were measured using a

ruler. The ulcer size was measured once a week for 4 weeks. The result showed that the

end of 4 weeks, mean surface area in Group A is reduced to 4.58 cm2 from 9.79

cm2 which is higher than that in the control group. Also, the average rate of healing in

Aloe vera gel is more than control group. Percentage reduction in ulcer surface area was

calculated to be much more in Group A as compared to Group B. The study concluded

that Aloe vera gel is highly effective in treatment of chronic ulcers and stimulates the

growth of wound healing.28

A Quasi experimental study was conducted to assess the effectiveness of aloe

vera gel in healing of pressure ulcers in Chennai. Quasi experimental two group pre

assessment and post assessment design was used.60 samples selected 30 were

included for both experimental and control group using nonrandom convenient sampling

technique. The subjects for the study were selected based upon the of Barbara Braden

and Nancy Bergstrom wound assessment scale within the score of 15 -18 or the mild

degree pressure ulcer with Grade – I. Tool used for data collection was Pressure Ulcer

Scale for Healing , on the 1st day, 5th day, 10th day and 15th day for both groups. The

result showed thathaving the healing mean score of 7.50 and in control group, subjects

25
were having 5.93 score. The study concluded that aloe Vera Gel was very effective in

healing of pressure ulcers.29

A study was conducted to assess the Impact of Aloe vera and Calendula on

Perineal Healing after Episiotomy in primiparous women admitted in Lolagar hospital,

Tehran.111 qualified primiparous women were selected by randomized control trial

method. They were randomly categorized into three groups of control (n=1) and

experimental (n=2) groups. The women in experimental group used Aloe vera and

Calendula Ointment every 8 hours and the control group used hospital routine on

episiotomy. Intervention was given for 5 days. Tools used for data collection was REEDA

scale. The result showed that the mean of approximation grade 5 days after episiotomy

had statistically significant difference between Aloe vera and control group (P=0.007),

between Calendula and control group (P=0.04). There was not statistically significant

difference between Aloe Vera and Calendula groups (P=0.69).The study concluded that

aloe vera and Calendula ointment considerably increases the speed of episiotomy

wound healing so it can be used for quickening the episiotomy healing.30

A study was conducted to assess the effect of aloe vera gel, calendula officinalis

ointment & simple prophylactic sacral dressings for pressure injury development in Iran.

90 critically ill patients were selected. They were randomly categorized into three groups.

Patients in group ‘A received Aloe Vera gel; patients in group ‘B’ received Calendula

officinalis ointment prophylactic dressing twice a day; & patients in group ‘C’ received

simple prophylactic dressing twice a day. Tool used for data collection was Braden scale.

The result showed that the frequency distributuion of the pressure injury development in

the two groups receiving Calendula officinalis ointment & Aloe vera gel dressing was the

same & there was no significant difference between them (p>0.05). The study concluded

26
that the use of aloe vera gel & Calendula officinalis ointment prophylactic dressing can

be effective in prevention of pressure injury.31

A study was conducted to assess is aloe vera effective for wound healing in

Brazil. Scientific articles were selected from the Pub-Med & LILACS databases between

February 2018 & Juli 2018, by using the English & Portuguese words of “Aloe Vera”.

“Wound healing” & “Tissue repair”. Total 229 articles were found in Pub Med & 63

articles were found in LILACS. After reading the abstracts, 30 articles that reported how

the pharmacological properties of aloe vera influence the healing process were selected.

The result showed that the Aloe vera exerted positive effects on the treatnment of oral

mucositis & the reduction of candidiasis in patients with cancer. The study concluded

that the literature supports the anti-inflammatory & cicatricial potential of aloe vera, which

has wide indication for the treatment of several conditions.32

A study was conducted to assess the effect of aloe vera & turmeric paste as a

supplementary medicine in oral submucosal fibrosis in Varanasi, Uttarpradesh. 140

critically diagnosed patients were selected. They were categorized into two groups 70

each. Patients in group ‘A’ received Triamcinolone ointment alone & patients in group ‘B’

received Triamcinolone ointment along with turmeric & aloe vera paste. Intervention is

given 3-4 times a day. Tool used for data collection was Visual analogue scale. The

result showed that the experimental group is having greater benefit than the control

group in inter incisal distance & in visual analogue scale (p=0.551). The study concluded

that the use of Turmeric & Aloe vera are a good supplement agents which not only help

in reducing the burning sensation but also useful in reducing the fibrosis.33

A study was conducted to assess the effectiveness of aloe vera & antioxidant

along with physiotherapy in the management of oral sub mucus fibrosis. 40 diagnosed

27
patients were selected. They were categorized into two groups. Patients in group ‘A

included 20 patients who received aloe vera gel with physiotherapy & patients in group

‘B’ included 20 patients who received antioxidant capsules twice a daily for 3 months

along with physiotherapy exercises. Intervention is given 4 times a day. The following

parameters that are burning sensation, mouth opening, tongue protrusion & cheek

flexibility were recorded at each visit. The result showed that improvement in all the

parameters was seen with the individuals receiving aloe vera gel in comparison to

antioxidants. The study concluded that the aloe vera provide better result in comparison

to antioxidants.34

A randomized double-blind case control study was conducted to assess the

comparative evaluation of 2% curcumin & 2% aloe vera gel in the management of

chronic recurrent oral aphthous ulcers. 60 patients were selected to collect the data.

Intervention is given 3 times a day for 2 weeks. Tool used for data collection is clinical

assessment & pain scale. The result showed that the mean age group of patients was

20±4.68 years. The study concluded that the 2% aloe vera gel is found to be more

effective in reducing the pain, inflammation & burning sensation. 2% curcumin gel was

found to be effective in decreasing the size & duration of healing of the ulcerative

lesion.35

A study was conducted to assess the phytotherapeutic effect of aloe vera in Iran.

A total of 54 papers out of 63 randomized controlled trials & review articles were finally

selected by using Google Scholer, PubMed & Science direct with keywords. The result

showed that aloe vera is one of the most well known herbal medicines with considerable

medicinal properties such as hypolipedemic, hypoglycaemic, antioxidant, anti-

inflammatory, wound healing, antibacterial & antiviral activities. The study concluded that

28
the chemical compounds contained naturally in aloe vera are expanding our disease

treatment choices & benefit us with their wide range of properties for the management of

diverse disorders.36

A randomized-controlled clinical trial with slit-mouth study was conducted to

evaluate the efficacy of aloe vera on wound healing & postoperative pain following

periodontal flap surgery. 60 patients devided into experimental & control group.

Experimental group received fresh aloe vera extract post-operatively. Tool used for data

collection is Early Healing Index after the first week & healing Index after the 1st, 2nd & 3rd

week following therapy. The result showed that better healing was observed in

experimental group in comparison to control group in the 1st postoperative week as

recorded by EHI (P<0.001) & HI (P=0.02. However there were no significant differences

between the experimental & control group in the 2nd (P=0.10) & 3rd (P=0.53) weeks. The

study concluded that the application of fresh aloe vera extract was effective in

significantly improving scores in the first post-operative week.37

A prospective & comparative randomized type of study was conducted to assess

the aloe vera gel dressing & conventional dressing in chronic wounds in Pune. 50

patients were selected to collect the data. Patients were divided into 2 groups (25

patients in each group) Group A patients receiving aloe vera gel dressing & Group B

patients receiving normal saline & povidone iodine dressing. Intervention is given for 4

weeks. Tool used for data collection is clinical assessment scale. The result showed that

at the end of 4 weeks mean surface area in group A is reduced to 4.58 cm2 from 9.79

cm2 which is higher than that in control group also the average rate of healing in aloe

vera gel is more than that of control group. The study concluded that aloe vera gel is

highly effective in treatment of chronic ulcers & stimulate the growth of wound healing.38

29
SUMMARY

This chapter deals with various reviews of literature related to prevalence of

episiotomy, effectiveness of calendula ointment and effectiveness of aloe vera gel on

episiotomy wound.

CONCLUSION

According to reviews it is concluded that various interventions are found to reduce

episiotomy pain and enhance the healing process. There are various treatment

modalities that have been commonly practiced which include hot and cold application,

sitz bath, infra-red therapy and application of procaine spirit to compliment the effect in

wound healing, but calendula ointment and aloe vera gel are more effective than other

remedial measures for episiotomy wound healing because both are natural products and

easily available. According to review both are having same effect on episiotomy wound

and having anti-inflammatory, anti-virus, antimicrobial and antifungal, moisturizing

properties so, it fasters wound healing.

30
 CHAPTER-III

RESEARCH

METHODOLOGY

31
 CHAPTER-III

RESEARCH METHODOLOGY

INTRODUCTION

Research methodology is needed because it facilitates the smooth sailing of the

various research operations, thereby making research as efficient as possible, yielding

maximum information with minimal expenditure of effort, time and money. Methodology

is the systematic study of methods that are, can be, or have been applied within a

discipline.39

This chapter deals with description of methodology and different steps which are

undertaken for gathering and organizing data. It includes details about research

approach, research design, variables, setting, inclusive and exclusive criteria, sampling

technique, sample size, development of tool, content validity, reliability, pilot study, data

collection, and data analysis.

RESEARCH APPROACH

Research approach refers to the plan and procedure that consists of the steps of

broad assumptions to detailed methods of data collection, analysis and interpretation.40

The investigator examined causal relationships to determine the effect of one

variable on another. It involved implementing an intervention and examining the effect of

calendula ointment and aloe vera gel using selected methods of measurement. The

quantitative evaluative approach was considered the most appropriate for this study.

32
RESEARCH DESIGN

The research design is the master plan specifying the methods and procedures for

collecting and analysing the needed information in a research study.9

In this study Experimental two groups Pre-test Post-test design was selected as a

research design. This study involves evaluation of the effectiveness of calendula

ointment versus aloe vera gel application on episiotomy wound in postnatal mothers;

while they have been observed for episiotomy healing by REEDA scale i.e. Redness,

Edema, Ecchymosis, Discharge, and Approximation.

The type of study design is as follows:

Group Pretest Treament Post-test

E1 O1 X1 O2

E2 O1 X2 O2

In this study, for analysis two observation scoring has taken (pre-test score and

post test score of 4th day) and intervention is given 3 times a day for 3 days. There were

only two observations (Pre-test & pot-test) so, the study is Experimental two groups Pre-

test Post-test design. The interpretation of the symbols is as follows:

E1 = Experimental group ‘A’ (calendula ointment)

E2 = Experimental group ‘B’ (aloe vera gel)

O1 = Pre test assessment of episiotomy wound

O2 = Post test assessment of episiotomy wound

X1 = The intervention (application of calendula ointment)

33
X2 = The intervention (application of aloe vera gel)

Analysis was done by using descriptive and inferential statistics in the present

study. The analysed data was presented in the form of graphs and tables.

VARIABLES UNDER STUDY

Variables are qualities, quantities, properties or characteristics of people, things or

situations that change or vary.9

Two variables were identified in this study.

Independent variable: - An independent variable that are purposely manipulated or

changed by the researcher.9

The independent variable in this study is Calendula ointment & Aloe vera gel application.

Dependent variable: - A dependent variable that change as the independent variable is

manipulated by the researcher.9

The dependent variable in this study is episiotomy wound.

SETTING OF THE STUDY

Setting refers to the area where the study is conducted. It is the physical, social,

or experimental context within which research is conducted41

The investigator selected postnatal wards of selected Maternity Hospitals.

POPULATION

Population denotes the entire group of subjects under study. The population is

defined as a complete set of elements (persons or objects) that possess some common

characteristic defined by the sampling criteria established by the researcher.9

34
 1. Target population- The entire group of people or objects to which the researcher

wishes to generalize the study findings.9

In this study, the target population comprised of postnatal mothers with

episiotomy admitted in postnatal wards of selected hospitals.

2. Accessible population- The proportion of the population to which the researcher

has reasonable access; may be a subset of the target population. 9

In this study, the accessible population comprised of postnatal mothers

with episiotomy admitted in postnatal wards of selected hospitals.

SAMPLES

A sample is a representative unit of a target population, which is to be worked

upon by researchers during their study. 9

In the present study the sample were postnatal mothers with episiotomy and who

fulfilled the inclusion criteria.

SAMPLING TECHNIQUE

Sampling technique refers to the process of selecting a portion of the population

to represent the entire population.9

In this study, purposive sampling technique was adopted to select the subjects.

Purposive sampling is a non-probability sampling where subjects are selected because

of investigator’s study purpose.

35
SAMPLE SIZE

Sample size refers to the number of participants or observations included in a

study.42

Study sample in Experimental group ‘A’ and Experimental group ‘B’ comprised of

20 postnatal mothers with episiotomy admitted in the postnatal wards of the selected

hospitals.

SAMPLE SIZE CALCULATION WITH FORMULA

Estimating difference between µ1 & µ2

µ1= 0.66 µ2=o.83

S1=0.51 S2=0.41

S=pooled SD=0.46

d= absolute precision=0.21

n= 2×Z12S2

d2

n= 2× (1.96)2(0.46)2

(0.21)2

n=38

Minimum sample size for the study=38

Sample taken in each group =20

36
CRITERIA FOR SELECTION OF SAMPLE

It refers to the essential characteristics of a subject or respondent such as ability

to read and write responses on the data collection instruments.43

The following criteria were used in the present study to select the samples.

Inclusion Criteria

1. Postnatal mothers with episiotomy from day 1

2. Postnatal mothers who are willing to participate in the study

3. Those were available at the time of data collection

Exclusion criteria

1. Mothers with severe complications of perineum/ episiotomy

2. Mothers who are allergic to calendula ointment or aloe vera gel

DEVELOPMENT OF TOOL

Tool refers to an instrument used to collect information for performance

assessments, self evaluations and external evaluations.44

The tool was developed by the researcher with references of books, review of

literature, under the guidance of expert. In this study the tool was prepared on the basis

of the objectives of the study.

The following steps were adopted prior to development of tool:

1. Review of literature provided adequate content area for the tool preparation.

Various literatures had been referred to finally decide on the effect of calendula

ointment versus aloe vera gel on episiotomy wound.

37
 2. Consultation and discussion with experts related to the selection of topic and

about the workout plan.

3. Personal experience and discussion with colleagues.

PREPARATION OF THE TOOL

Section I- Demographic Profile

It describes Age, Education, Type of work & Parity.

Section II- REEDA scale

 REEDA score = 3 points for all 5 parameters.

Interpretation: - Minimum score: 0, Maximum score: 15

The higher the score the more severe the perineal trauma.

 Modified observational Checklist (REEDA scale)

1. Redness

2. Edema

3. Ecchymosis

4. Discharge

5. Approximation

TESTING OF THE TOOL:-

The tool selected for data collection was tested for its content validity,

feasibility and reliability.

38
VALIDITY:-

Validity refers to an instrument measures what it is intended to measure.9

Content validity concerns the degree to which an instrument has an appropriate

sample of item for the construct being measured and adequately covers the construct

domain.

To ensure the content validity tool was given to 14 experts from different fields.

The experts include 3 Gynaecologists, 1 Ayurveda doctor, 1 statistician and 9 nursing

experts. The experts were requested to give their opinions and suggestions regarding

the relevance of content and whether they agree or disagree with the tool or instrument

and provide the necessary remarks.

Few validators suggested, to modify procedure and given instructions to keep

uniformity in procedure. REEDA scale and observational checklist were approved by the

experts. A few suggestions were given by the experts and changes were made.

RELIABILITY:-

Reliability is the degree of consistency or accuracy with which an instrument

measures the attribute it is designed to measure.9

Normal value of reliability ranges from -1 or +1.

As per statisticians advice reliability is not calculated because the tool is standard

(REEDA scale) and universally accepted. The reliability for the research tool of

observational checklist was elicited by using Inter-rater reliability test (r=0.97) which is

highly reliable. Hence, the tool for the research study was considered reliable.

39
PILOT STUDY

Study carried out at the end of the planning phase of research in order to explore

and test the research elements to make relevant modifications in research tools and

methodology.9

Pilot study was conducted on 12 postnatal mothers with episiotomy at selected

hospitals in the city, from 24/10/2020 to 30/10/2020. The pilot study data analysis

included both descriptive and inferential statistics. The written permission was obtained

from the medical director of the selected hospitals prior to data collection. The aims,

objectives and nature of the study were explained to the participants. Confidentiality was

assured to all the participants and a written consent was obtained from them. After initial

survey postnatal mothers with episiotomy were selected and purposely assigned to both

the experimental groups.

The pilot study result indicated that the tool is reliable. No further change was

made in the tool after the pilot study. The investigator then proceeded for the final study.

FEASIBILITY OF THE PILOT STUDY

A feasibility of the study is an assessment of the practicality of a proposed project

or system.45

Pilot study revealed that sampling method and total number of subjects were

appropriate for the study, so the study conducted was feasible.

40
DATA COLLECTION PROCEDURE

Data collection refers to the procedure of collecting, measuring and analyzing

accurate insights for research using standard validated techniques.46 Data was collected

by the investigator herself. The main study was conducted in selected maternity

hospitals from 22/11/2020 to 22/12/2020. Before the actual data collection, the

investigator has completed the following formalities.

In Experimental group ‘A’ (Calendula ointment)

1. After securing written permission from the respective authority, based on inclusion and

exclusion criteria the subjects were selected.

2. Informed & written consent was taken from selected subjects after explaining the

study.

3. 20 subjects were included in group ‘A’ using non probability purposive sampling

technique.

4. Pre-test was conducted using REEDA scale.

5. Perineal care was given to each patient before application of calendula ointment

on episiotomy wound.

6. 3ml of calendula ointment was taken with the help of spatula. Calendula ointment

was spread in line on sterile 2×2 guaze piece & it was applied on episiotomy

wound. 3ml of aloe vera gel was taken with the help of spatula.

7. The intervention was provided for 3 times in a day for 3 days in morning,

afternoon & evening.

th
8. Post-test was carried out on 4 day by using REEDA scale

9. Data collected was analysed.

41
In Experimental group ‘B’ (Aloe vera gel)

1. After securing written permission from the respective authority, based on inclusion and

exclusion criteria the subjects were selected.

2. Informed & written consent was taken from selected subjects after explaining the

study.

3. 20 subjects were included in group ‘B’ using non probability purposive sampling

technique.

4. Pre-test was conducted using REEDA scale.

5. Perineal care was given to each patient before application of aloe vera gel on

episiotomy wound.

6. 3ml of aloe vera gel was taken with the help of spatula. Aloe vera gel was spread

in line on sterile 2×2 guaze piece & it was applied on episiotomy wound.

7. The intervention was provided for 3 times in a day for 3 days in morning,

afternoon & evening.

8. Post-test was carried out on 4th day by using REEDA scale

9. Data collected was analysed.

PLAN FOR DATA ANALYSIS:-

Data analysis is the process of systematically applying statistical and/or logical

techniques to describe and illustrate, condense and recap, and evaluate data.47

The data obtained will be analyzed using both descriptive and inferential statistics

based on objectives and research question of the study.

42
 FIG 2: SCHEMATIC REPRESENTATION OF THE STUDY

ASSESSMENT OF
EPISIOTOMY
WOUND

SAMPLE SIZE SAMPLING

POPULATION 40 postnatal TECHNIQUE
Postnatal mothers with Purposive
mothers with episiotomy sampling
episiotomy admitted in technique
wound postnatal wards

Pre test
assessment in TOOL
both Demographic
Application of
Experimental profile, REEDA
calendula
group ‘A’ & scale
ointment &
Experimental
aloe vera gel in
group ‘B’
Experimental
group ‘A’ &
Experimental
group ‘B’

Post test
Analysis, assessment in
Interpretation, both the
Conclusion of the Experimental
study groups

43
SUMMARY

This chapter deals with the research methodology adopted for the study

and includes description of the research approach, design, setting, variables under

study, samples, sampling technique, tools and techniques and their validity, reliability,

pilot study, data gathering process and plan for data analysis. The data was planned to

be analyzed in terms of descriptive and inferential statistics.

44
 CHAPTER-IV

ANALYSIS AND

INTERPRETATION
CHAPTER-IV

45
 CHAPTER-IV

ANALYSIS AND INTERPRETATION

INTRODUCTION

Data analysis is defined as, “the categorizing, ordering, manipulating and

summarizing of the data to obtain answers to research questions.”

The purpose of analysis is to deal with data in an intelligent and interpretable form.

Analysis and interpretation helps the researcher as well as the reader to know about findings,

result as well as conclusion of that study. It can also give guidance for further study or

evidence based practices in the field.

The analysis and interpretation of data involves the objective material in the

possession of the researcher and her subjective reactions and desire to derive from the

data the inherent meanings in that relation to the problem. The researcher must determine

whether or not the study will satisfy all the conditions of the problem and used descriptive

and inferential statistics in the present study.

OBJECTIVES OF THE STUDY

1. To assess the episiotomy wound among postnatal mothers in both the

experimental groups.

2. To assess the effectiveness of calendula ointment on episiotomy wound among

postnatal mothers in experimental Group A.

3. To assess the effectiveness aloe vera gel on episiotomy wound among postnatal

mothers in experimental Group B.

46
 4. To compare the effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound among postnatal mothers in both the experimental groups.

RESEARCH QUESTION

Does calendula ointment or aloe vera gel have effect on episiotomy wound among

postnatal mothers admitted in selected hospitals?

HYPOTHESIS

H0: - There will be no significant difference between the effectiveness of calendula

ointment and aloe vera gel on episiotomy wound in both experimental groups.

H1:- There will be significant difference between the effectiveness of calendula ointment

and aloe vera gel on episiotomy wound in both experimental groups.

ORGANIZATION OF THE FINDINGS

The data collected of the study was classified, organized and analysed under

following sections:

SECTION I- Analysis of demographic data of postnatal mothers in terms of frequency

and percentage.

SECTION II- Pre-test and post-test assessment of episiotomy wound by REEDA scale

SECTION III- Evaluation of effectiveness of calendula ointment (Group ‘A’) & aloe vera

gel (Group ‘B’) on episiotomy wound.

47
SECTION IV- Comparison of effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound.

SECTION-I

Table no 1: Analysis of demographic data of postnatal mothers in terms of frequency

and percentage.

n=40

Sr. Variable Groups Group A Group B

No. Frequency Percentage Frequency Percentage

1 Age(in yrs) 20-24 14 70.00 14 70.00

25-30 5 25.00 6 30.00

31-35 1 5.00 0 0.00

36-40 0 0.00 0 0.00

2 Education Illiterate 0 0.00 0 0.00

Primary Education 5 25.00 3 15.00

Sec. Education 10 50.00 7 35.00

Graduate 5 25.00 10 50.00

3 Type of Work Sedentary 0 0.00 0 0.00

Moderate 20 100.00 20 100.00

Heavy 0 0.00 0 0.00

4 Parity Primipara 12 60.00 10 50.00

Multipara 8 40.00 10 50.00

48
Graph No 1: Cluster bar graph showing percentage distribution of postnatal mothers

according to age.

Age Distribution

70%. 70%
70.00

60.00

50.00
Percentage

Group A
40.00
30%
30.00 25% Group B

20.00

10.00 5% 0%
0% 0%
0.00
20-24 25-30 31-35 36-40

Age Group

Above cluster bar graph shows majority of postnatal mothers 14 (70 %) in experimental

group ‘A’ and 14 (70 %) in the experimental group ‘B’ were in the age group between

20-24 yrs. Remaining of postnatal mothers in experimental group ‘A’ 5 (25%) were in the

age group between 25-30 yrs, 1 (5%) were in the age group between 31-35 yrs, and 6

(30%) in the experimental group ‘B’ were in the age group between 25-30 yrs.

49
Graph No 2: Cluster pyramid graph showing percentage distribution of postnatal

mothers according to education.

Education

50% 50%
50.00
45.00
40.00 35.%
35.00
Percentage

30.00 25% 25% Group A

25.00
20.00 15%
Group B
15.00
10.00
5.00 0% 0%
0.00
Illiterate Primary Secondary Graduate
Education Education

Education

Above cluster pyramid graph showing majority of postnatal mothers 10 (50%) in

experimental group ‘A’ had secondary education and 10 (50%) in experimental group ‘B’

were graduate. Remaining postnatal mothers 5 (25%) in experimental group ‘A’ had

primary education, 5 (25%) had graduate and 7(35%) in experimental group ‘B’ had

secondary education, 3(15%) in experimental group ‘B’ had primary education.

50
Graph No 3: Bar graph showing the percentage distribution of postnatal mothers

according to type of work.

Type of Work

100% 100%
100.00
90.00
80.00
Percentage

70.00 Group A
60.00
50.00
Group B
40.00
30.00
20.00
10.00 0% 0% 0% 0%
0.00
Sedentary Moderate Heavy

Above bar graph showing all postnatal mothers 40 (100 %) in both experimental group

‘A’ and experimental group ‘B’ were doing moderate type of work.

51
 Graph No 4: Pie graph showing the distribution of postnatal mothers according to parity.

Parity - Group A Parity - Group B

Multipar
Multipara a
40% 50%
Primipara Primipara

Multipara Multipara

Primipara Primipara
60% 50%

Above pie graph showing majority of postnatal mothers 12 (60%) in experimental group ‘A’

were primipara and 10 (50%) in experimental group ‘B’ were primipara & 10 (50%) were

multipara. Remaining postnatal mothers 8 (40%) in experimental group ‘A’ were multipara

52
 SECTION-II

Pre-test and post-test assessment of episiotomy wound by REEDA scale

GRAPH NO 5: Cylindrical Graph showing pre-test and post-test assessment of

episiotomy wound by REEDA in experimental group ‘A’ (calendula ointment).

Episiotomy Wound Status - Group A

20 90%

15 65%
Pre
Frequency

Test
10 35%
Post
Test
5 10%
0% 0% 0% 0%
0
Healed Moderately Mildly healed Not healed
healed

Above cylindrical graph shows in experimental group ‘A’ majority of postnatal mothers 18

(90%) in pre-test where mildly healed were as in post-test majority of postnatal mothers

13 (65%) were moderately healed. Remaining postnatal mothers 2 (10%) in pre-test

were not healed &in post-test remaining postnatal mothers 7 (35%) were healed.

53
Graph No 6: Cylindrical graph showing pre-test and post-test assessment of episiotomy

wound by REEDA in experimental group ‘B’ (aloe vera gel).

Episiotomy Wound Status - Group B

95%
20
75%
Pre Test
15
Frequency

10
25% Post Test
5
5%
0% 0% 0% 0%
0
Healed Moderately Mildly healed Not healed
healed

Above cylindrical graph shows in experimental group ‘B’ majority of postnatal mothers 19

(95%) in pre-test were mildly healed where as in post-test majority of postnatal mothers

15 (75%) were moderately healed. Remaining postnatal mothers 1 (5%) in pre-test were

not healed & in post-test remaining postnatal mothers 5 (25%) were healed.

54
 SECTION-III

Evaluation of effectiveness of calendula ointment (Group ‘A’) & aloe vera gel

(Group ‘B’) on episiotomy wound

Table No 2: Pre-test and post-test evaluation of effectiveness of Calendula ointment

(Group A) on episiotomy wound.----------------- (Paired ‘t’ test)

n=20

Group A Size Mean S.D. T P

PRE Test 20 10.05 0.39

61.77 0.000
POST Test 20 0.65 0.48

Table no 2 reveals that data can be seen that pre-test scoring mean in experimental

group ‘A’ was 10.5 & standard deviation was 0.39. The post-test scoring mean in

experimental group ‘B’ was 0.65 & standard deviation was 0.48. The calculated paired

value was t=61.77 with p value <0.001 hence, it shows that application of calendula

ointment (Group ‘A’) is having significant effect on episiotomy wound.

55
Table No 3: Pre-test and post-test evaluation of effectiveness of Aloe vera gel (Group B)

on episiotomy wound. ------------------------------- (Paired ‘t’ test)

n=20

Group B Size Mean S.D. T P

PRE Test 20 9.80 0.52

58.97 0.000
POST Test 20 0.75 0.44

Table no 3 reveals the pre-test scoring mean in experimental group ‘B’ was 9.80 &

standard deviation was 0.52. The post-test scoring mean in experimental group ‘B’ was

0.75 & standard deviation was 0.44. The calculated paired value was t=58.97 with p

value <0.001 hence, it shows that application of aloe vera gel (Group ‘B’) is having

significant effect on episiotomy wound.

56
 SECTION-IV

Comparison of effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound

Table No 4: Post test assessment of effectiveness of calendula ointment versus aloe

vera on episiotomy wound.------------------------------------------(Unpaired ‘t’ test)

n=40

Post Test Size Mean S.D. T P

Group A 20 0.65 0.48

0.68 0.503
Group B 20 0.75 0.44

Table No. 4 reveals that the post-test scoring mean in experimental group ‘A was 0.65 &

standard deviation was 0.48 & the post-test scoring mean in experimental group ‘B’ was

0.75 & standard deviation was 0.44. The calculated paired value was t=0.68 with p value

>0.001. Hence, H0 is accepted & H1 is rejected.

57
 Episiotomy Wound - Group A vs Group B
0.76 0.75
0.74
0.72
Group A
Average

0.70
0.68
0.66 0.65 Group B

0.64
0.62
0.60
Group A Group B
Test

Graph No. 7 reveals that the post-test scoring mean in experimental group ‘A was 0.65 &

& the post-test scoring mean in experimental group ‘B’ was 0.75.

It is concluded that, the post-test scoring mean in experimental group ‘A’ was 0.65 & in

experimental group ‘B’ was 0.75. Calendula ointment was slightly effective than aloe

vera gel but there was no significant difference between the effectiveness of calendula

ointment and aloe vera gel on episiotomy wound in both the experimental groups.

SUMMARY

This chapter deals with analysis and interpretation of the data collected which
shows that calendula ointment & aloe vera gel application was effective in both the
experimental groups.

58
 CHAPTER-V

SUMMARY,

FINDINGS,

CONCLUSION,

DISCUSSION AND

RECOMMENDATIONS

59
 CHAPTER-V

SUMMARY, FINDINGS, CONCLUSION, DISCUSSION AND RECOMMENDATIONS

INTRODUCTION

This chapter presents brief summary of the study and its significant findings,

conclusion and implication of the study in nursing administration, nursing services,

nursing education and nursing research. It also includes the implication and

recommendations for further study.

The aim of the study was, “A comparative study to assess the effectiveness of

calendula ointment versus aloe vera gel on episiotomy wound among postnatal mothers

admitted in selected hospitals.”

BRIEF SUMMARY OF THE STUDY

Postnatal period is an important time in mother’s life. In these study postnatal

mothers with episiotomy is involved. Effectiveness of calendula ointment versus aloe

vera gel application in postnatal mothers was evaluated.

TITLE

To assess the effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound among postnatal mothers admitted in selected hospitals.

60
PROBLEM STATEMENT

A comparative study to assess the effectiveness of calendula ointment versus

aloe vera gel on episiotomy wound among postnatal mothers admitted in selected

hospitals.

OBJECTIVES OF THE STUDY

1. To assess the episiotomy wound among postnatal mothers in both the

experimental groups.

2. To assess the effectiveness of calendula ointment on episiotomy wound among

postnatal mothers in experimental Group A.

3. To assess the effectiveness aloe vera gel on episiotomy wound among postnatal

mothers in experimental Group B.

4. To compare the effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound among postnatal mothers in both the experimental groups.

ASSUMPTION

Calendula ointment & aloe vera gel application may have effect on episiotomy

wound in postnatal mothers.

61
HYPOTHESIS

H0: - There will be no significant difference between the effectiveness of calendula

ointment and aloe vera gel on episiotomy wound in both experimental groups.

H1:- There will be significant difference between the effectiveness of calendula ointment

and aloe vera gel on episiotomy wound in both experimental groups.

RESEARCH QUESTION

Does calendula ointment or aloe vera gel application have effect on episiotomy

wound in postnatal mothers?

RESEARCH APPROACH AND DESIGN

For this study the research approach is Quantitative approach. The research

design selected for this study was experimental two group pre-test post-test design.

SETTING OF THE STUDY

The study was conducted in selected maternity hospitals.

VARIABLES

There are two variables identified in this study. They are independent and

dependent variables.

Independent variables-In this study application of calendula ointment versus aloe vera

gel was independent variables.

62
Dependent variable- In this study episiotomy wound was dependent variable.

POPULATION

Population is the entire aggregation of cases that meet a designed set of criteria.

Target population- In this study, the target population comprised of postnatal mothers.

Accessible population- In this study the accessible population comprised of postnatal

mothers with episiotomy admitted in the postnatal wards of the selected hospitals in the

city.

SAMPLING TECHNIQUE

In this study, purposive sampling technique was adopted to select the

subjects. Purposive sampling is a non-probability sampling where subjects are selected

because of investigator’s study purpose.

SAMPLE SIZE

Sample size refers to the number of participants or observations included

in a study.

Study sample in Experimental group ‘A’ and Experimental group ‘B’ comprised of

20 postnatal mothers with episiotomy admitted in the postnatal wards of the selected

hospitals.

63
TOOLS

Section I- Consists of demographic profile which includes age in years, education, type

of work and parity of the mother.

Section II- Consists of observation of episiotomy wound in postnatal mothers by

1. REEDA scale i.e. Redness, Edema, Ecchymosis, Discharge and Approximation.

2. Modified observational checklist (REEDA scale)

VALIDATION AND RELIABILITY

The content validity was obtained by consulting experts from medical, Ayurveda

and nursing fields. Modified observational checklist and tool by REEDA scale were

approved by experts. To establish reliability of modified observational checklist, Inter

rater method obtained was r=0.97.

Reliability of (REEDA SCALE) is not calculated because the tool is standard and

universally accepted. Hence, the tool for the research study was considered reliable.

CONCEPTUAL FRAMEWORK

A conceptual framework is a theoretical approach to study the problems that are

scientifically based which emphasizes selection, arrangement & classification of its

concepts. Selecting a nursing conceptual framework helps the researcher to identify

problem that are of significant to the discipline of nursing.

The study was based on the concept that application of calendula ointment versus

aloe vera gel on wound among postnatal mothers receiving episiotomy. The investigator

adopted the General System Theory introduced by Ludwig Von Bertalanffy (1968).

64
According to this theory, a system is a group of elements that interact with one another in

order to achieve the goal. It has 5 factors as follows,

1. Input

2. Process

3. Output

4. Feedback

5. Environment

MAJOR FINDINGS OF THE STUDY

The analysis of the demographic data of the study samples gave an idea about

the general characteristics of the postnatal mothers admitted in selected Maternity

hospitals.

The following are the major findings of the study

SECTION I- Findings related to demographic profile

The findings shows that majority of postnatal mothers 14 (70 %) in experimental

group ‘A’ and 14 (70 %) in the experimental group ‘B’ were in the age group between 20-

24 yrs. Remaining of postnatal mothers 1 (5%) in experimental group ‘A’ were in the age

group between 31-35 yrs, 5 (25%) were in the age group between 25-30 yrs and 6 (30%)

in the experimental group ‘B’ was in the age group between 25-30 yrs.

Majority of postnatal mothers 10 (50%) in experimental group ‘A’ had secondary

education and 10 (50%) in experimental group ‘B’ were graduate. Remaining postnatal

65
mothers 5 (25%) in experimental group ‘A’ had primary education, 5 (25%) had

secondary education and 3 (15%) in experimental group ‘B’ had primary education.

All postnatal mothers 40 (100 %) in both experimental group ‘A’ and experimental

group ‘B’ were doing moderate type of work.

Majority of postnatal mothers 12 (60%) in experimental group ‘A’ were primipara

and 10 (50%) in experimental group ‘B’ were primipara & 10 (50%) were multipara.

Remaining postnatal Mothers 8 (40%) in experimental group ‘A’ were multipara

SECTION II- Assessment of episiotomy wound before & after intervention in both

the experimental groups among postnatal mothers.

The REEDA Scale was used for the assessment of Episiotomy Wound Healing

among the postnatal mothers.

In Experimental Group ‘A’ majority of postnatal mothers 18 (90%) in pre-test

where mildly healed were as in post-test majority of postnatal mothers 13 (65%) were

moderately healed. Remaining postnatal mothers 2(10%) in pre-test were not healed &in

post-test remaining postnatal mothers 7 (35%) were healed.

In Experimental Group ‘B’ majority of postnatal mothers 19(95%) in pre-test were

mildly healed where as in post-test majority of postnatal mothers 15(75%) were

moderately healed. Remaining postnatal mothers 1(5%) in pre-test were not healed &in

post-test remaining postnatal mothers 5(25%) were healed.

66
SECTION III-Evaluation of effectiveness of calendula ointment (group ‘A’) versus

aloe vera gel (group ‘B’) application on episiotomy wound among postnatal

mothers.

Pre-test scoring mean in Experimental Group ‘A’ was 10.5 & standard deviation

was 0.39. The post-test scoring mean in experimental group ‘A’ was 0.65 & standard

deviation was 0.48.

Pre-test scoring mean in Experimental Group ‘B’ was 9.80 & standard deviation

was 0.52. The post-test scoring mean in experimental group ‘B’ was 0.75 & standard

deviation was 0.44.

SECTION IV- Comparison of effectiveness of calendula ointment versus aloe vera

gel on episiotomy wound among postnatal mothers.

The comparisons of the post-test means of the episiotomy wound among

postnatal mothers at selected hospitals done by the paired‘t’ test.

post-test scoring mean in Experimental Group ‘A was 0.65 & standard deviation

was 0.48 & the post-test scoring mean in experimental group ‘B’ was 0.75 & standard

deviation was 0.44. The calculated paired value was t=0.68 with p value >0.001. Hence,

H0 is accepted & H1 is rejected.

It is concluded that there was no significant difference between the effectiveness

of calendula ointment and aloe vera gel on episiotomy wound in both the experimental

groups.

It shows that use of calendula ointment as well as aloe vera gel improves the

condition of episiotomy wound among postnatal mothers at selected hospitals were

effective.

67
DISCUSSION

The findings shows that majority of postnatal mothers 14 (70 %) in experimental

group ‘A’ and 14 (70 %) in the experimental group ‘B’ were in the age group between 20-

24 yrs. Remaining of postnatal mothers 1 (5%) in experimental group ‘A’ were in the age

group between 31-35 yrs, 5 (25%) were in the age group between 25-30 yrs and 6 (30%)

in the experimental group ‘B’ was in the age group between 25-30 yrs. No similar

findings in this study.

Majority of postnatal mothers 10 (50%) in Experimental Group ‘A’ had secondary

education and 10 (50%) in Experimental Group ‘B’ were graduate. Remaining postnatal

mothers 5 (25%) in Experimental Group ‘A’ had primary education, 5 (25%) had

secondary education and 3 (15%) in Experimental Group ‘B’ had primary education. No

similar findings in this study.

All postnatal mothers 40 (100 %) in both Experimental Group ‘A’ and experimental

group ‘B’ were doing moderate type of work. No similar findings in this study.

Majority of postnatal mothers 12 (60%) in Experimental Group ‘A’ were primipara

and 10 (50%) in Experimental Group ‘B’ were primipara & 10 (50%) were multipara.

Remaining postnatal

Mothers 8 (40%) in Experimental Group ‘A’ were multipara. No similar findings in

this study.

The study findings shows that pre-test scoring mean in experimental group ‘A’

was 10.05 & standard deviation was 0.39. The pre-test scoring mean in Experimental

Group ‘A’ was 0.65 & standard deviation was 0.48. Whereas pre-test scoring mean in

Experimental Group ‘B’ was 89.80 & standard deviation was 0.52. The post-test scoring

mean in Experimental Group ‘A was 0.75 & standard deviation was 0.44.

68
 Similar findings were seen in a study conducted by Farideh Eghdampour,

Fereshteh Jahdie, Masomeh Kheyrkhah, Mohsen Taghizadeh, Somayeh naghizadeh &

Hamid Hagani to determine effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound. Study showed that pre-test scoring mean in Experimental Group ‘A’

was 4.40 & standard deviation was 1.48. The post-test scoring mean in Experimental

Group ‘A’ was 1.67 & standard deviation was 1.10. Pre-test scoring mean in

Experimental Group ‘B’ was 4.32 & standard deviation was 1.20. The post-test scoring

mean in Experimental Group ‘B’ was 1.62 & standard deviation was 0.92. Whereas Pre-

test scoring mean in control group was 4.32 & standard deviation was 1.38. The post-

test scoring mean in control group was 3.48 & standard deviation was 1.77.

Similar findings were seen in a study conducted by Preeti Maria Menezes.The

independent‘t’ value was computed to determine the effectiveness of aloe vera gel and

lavender oil on episiotomy wound healing and pain. The computed ‘t’ value for wound

healing (0.623) was lesser than table value 1.96 (t38=1.96, p<0.05).Hence H0 was

partially accepted. Hence aloe vera gel and lavender oil was equally effective on wound

healing.The computed ‘t’ value for pain (2.307) was greater than the table value 1.96

(t38=1.96, p<0.05). Hence H03 was partially rejected.The mean post test pain score in

aloe vera gel (3.8±1.02) group is lower than mean post test pain score in lavender oil

(4.55±0.97) group. Hence alovevera gel is more effective than lavender oil in reducing

pain.

Similar findings were seen in a study conducted by Prof. Rasha Essa, Assist.

Prof. Noha Mohamed and Dr.Hanan Kandeel to determine effect of aloe vera gel versus

normal saline on pain relief & healing process of episiotomy. On the 5th postnatal day

more than three-quarters (86.7%) of Aloe Vera group had complete healing of

69
episiotomy wound compared to only 36.7% of the normal saline group. Meanwhile

only13.3% of Aloe Vera group had partial healing compared to more than 53.3% of the

normal saline group. There was a statistically significant difference between both groups

regarding perineal healing scores (p < 0.0001) during the 5th postnatal days. On the

10th postpartum day, all of the Aloe Vera group did achieve complete healing of

episiotomy wound compared to 80%of the normal saline group. There was a statistically

significant difference between both groups (p < 0.0001).

Similar findings were seen in a study conducted by Mrs. S. Jayshree to determine

the effectiveness of fresh aloe vera gel application on pain relief & healing of episiotomy

wound. In post assessment level of wound healing in experimental group, 63.3% of the

postnatal mothers wound were healed, 36.7% were having mild wound healing. In

control group 100% of postnatal mothers were having mild wound healing. In post

assessment, experiment group postnatal mothers were having 0.37 wound healing score

and control group were having 2.77 wound healing score, so the difference was large

and it was statistically significant difference. The computed ‘t’ value of wound healing

(20.888) and pain (27.109) is greater than table value 2.05 (p<0.05). Hence aloe vera gel

was effective in episiotomy wound healing.

CONCLUSION OF THE STUDY

The conclusion drawn from the findings of the study are as follows:-

1. Calendula ointment & aloe vera gel is having same effect on episiotomy wound

but according to mean value Calendula ointment is little more effective than aloe

vera gel.

70
 2. Review of Literature has helped the investigator to gain in depth knowledge of

the content, to develop conceptual framework for the study, tool for data

collection and analysis of data.

3. The purpose of the study to determine the effectiveness of calendula ointment

versus aloe vera gel application on Episiotomy wound healing have proved

statistically and found effective in treating episiotomy wound healing amongst

post natal mothers.

From the study findings i. e, calendula ointment as well as aloe vera gel application is

effective method for episiotomy wound healing in both experimental groups.

NURSING IMPLICATION

The concept of health has changed from time to time. Traditionally, health had

disease as its central focus, which has now changed into complex multi-dimensional

models centering on a positive holistic approach towards the phenomenon of health with

emphasis on health promotion. The implications made in the study are of vital concern to

nursing practice, nursing education, nursing research and nursing administration.

NURSING PRACTICE

Calendula ointment & Aloe vera gel application are cost effective, easily available

interventions to treat episiotomy wound. Since these are natural treatments and had no

side effects it can be practiced in a clinical setting in order to improve wound healing & to

relieve patients discomfort caused by episiotomy wound. Theories like General System

Theory introduced by Ludwig Van Bertalanffy, on which this study is based, its

conceptual framework can be applied in practice set up; there by present study

71
increases evidence based practice in turn enhances the autonomous role of nursing

intervention.

NURSING EDUCATION

Calendula ointment and Aloe vera gel are used for various ailments such as

wound healing, pain, burns, dermatitis and aromatherapy which have already been

included in the nursing curriculum. The student nurses can study the physiological

effects of Calendula ointment and Aloe vera gel on episiotomy wound. The nursing

curriculum should give importance to nursing interventions rather than medical

management, and application of evidence based practices that are economical,

affordable and acceptable for the patients and their family.

NURSING ADMINISTRATION

Effective strategies to manage episiotomy wound with the use of non

pharmacological methods such as calendula ointment & aloe vera gel application should

be considered by a nurse administrator when designing materials, policies, forms and

procedures for obtaining effective, economical, acceptable, and non-pharmacological

complements to nursing care. The nurse administrator should also see that the student

and practicing nurses are well equipped with knowledge and skill through in-service

programmes. Nurses may be empowered with facilities to use these treatments.

NURSING RESEARCH

The aims of nursing research are to contribute the knowledge to expand and

broaden the scope of nursing. The nurse researcher can utilize the study finding in

72
developing model/theory/conceptual frame work. Based on the finding of the further

study the future research can be undertaken.

LIMITATIONS

1. The study was time bound.

2. The study was conducted on small sample size.

RECOMMENDATIONS

Based upon the study findings, the following recommendations were made for

future study.

1. A similar study can be replicated on a large sample in different settings to

strengthen the findings.

2. A comparative study can be conducted to assess the effectiveness of calendula

ointment & aloe vera gel application in combination with other complimentary

therapies.

3. A similar study can be conducted for 5 days at hospital setting.

4. Planned teaching programme can be done on knowledge of staff nurse regarding

calendula ointment & aloe vera gel application over episiotomy wound.

SUMMARY

The investigator has drawn these conclusions based on the study findings. In this

chapter the investigator has also dealt with the nursing implications of the study and the

limitations which the investigator experienced during the study.

73
BIBLIOGRAPHY

74
 BIBLIOGRAPHY

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vinodhini.pdf

2. Singh S, ThakurT, Chandhiok N, Singh B. Pattern of episiotomy use & its

immediate complications among vaginal deliveries in 18 tertiary care hospitals in

India. Indian Journal of Medicine & Research. 2016 jun 21; 143(4):474-80.

3. Eghdampour F, Jahdie F, Kheyrkhah M, Taghizadeh M. The impact of aloe vera &

calendula on perineal healing after episiotomy in primiparous women: A

randomized clinical trial. [Online]. 2013 Dec; Available from: URL:https://www.

ncbi.nlm.nih.gov/pmc/articles/ PMC4134148/

4. Seyyed AH, Seyyed AM & Saied A. The review on properties of aloe vera in

healing of cutaneous wounds. [Online].2015 may 19; Available from: URL:https:

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5. S. Jayshree. A study to assess the effectiveness of fresh aloe vera gel application

on pain relief & healing of episiotomy wound among postnatal mothers. [Online].

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6. Episiotomy Rates Vary Widely Worldwide [Online]. 2017 May 5; Available from:

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8. Buzzi M, Freitas F & Winter M. A prospective, descriptive study to assess the

clinical benefits of using Calendula officinalis hydroglycolic extract for the topical

treatment of diabetic foot ulcers. [Online]. 2016 Mar; Available from: URL: https://

www.ncbi.nlm.nih.Gov/pubmed/26978856

9. Sharma. SK. A textbook of nursing research & statistics. 3rded. New Delhi:

Elsevier; 2018.p. 43, 44, 45, 116, 163, 251.

10. Masoumeh R, Afsaneh K, Khosravi A, Purzahra. Prevalence and factors

associated with episiotomy in Shahroud City, Iran. International Journal of

Womens Health & Reproductive Science. 2016; 4(3):125-9.

11. Izuka EO, CC Dim & Izuka CE Obiora. Prevalence and predictors of episiotomy

among women at first birth in Enugu, Nigeria. Annals of Med and Health Sciences

Research 2014 Nov-Dec; 4(6):928-32.

12. Kartal B, Kizilirmark A. Demir G. Retrospective analysis of episiotomy prevalence

in Turkey. Jou Turk Ger Gyn Assoc 2017 Dec 15; 18(4):190-94.

13. Singh S, Thakur T, Chandhiok N, Singh B. Pattern of episiotomy & its immediate

complications among vaginal deliveries in 18 tertiary care hospitals in India. Ind

Jou Med Res.2016 jun 21; 143(4):p.474-80.

14. KAI-Ghammari. Predictors of routine episiotomy in primigravida women in

Oman.[Online].2016;Availablefrom:URL:https://www.ncbi.nlm.nih.gov

/m/PubMed/26856503

15. Pebolo FP. Prevalence and factors associated with episiotomy practice among

primiparous women in mulago national referral hospital, Uganda. International

journal of pregnancy & child birth.2019 Aug; 5(6):197-201.

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16. Hamdia MA. Warda HA. Namir GA. Prevalence & risk factors of episiotomy &

perineal tear in the maternity teaching hospital of Erbil city, Iraq. [Online] 2019;

Available from: URL:ejnm.hmu.edu.krd

17. Tefera T, Kebede B, Mekonen T. Prevalence of episiotomy & factors associated

with practice of episiotomy at St. Paul’s hospital, Addis Ababa, Ethiopia. Ethiopian

Journal of Reproductive Health.2019 July;11(3):215-20

18. Frequency of episiotomy & complications in the obstetrics service in

Colombia.2016. Available from URL:www.scielo.org.com

19. Jahdie F, Eghdampour F, Haselie A, Kheyrkhah M, Hagani H, Abasi Z. Effect of

calendula ointment in wound healing of episiotomy among primiparous women

admitted in Lolagar Hospital, Tehran. Jou Nor Khora Uni Med sci 2013; 4(5):117-

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20. Jahdie F. Impact of calendula ointment on cesarean wound healing: A

randomized controlled clinical trial. [Online]. 2018 Sep-Oct; Available from:

URL:https://pubmed.ncbi.nlm.nih.gov/30598929

21. Panahi Y, Sharif MR & Sahebkar A. Randomized comparative trial on

thetherapeutic efficacy of topical Aloe vera cream & calendula officinalis ointment

on Diaper Dermatitis in children. Scientific World Journal.2012 Apr 19;3(4):127-32

22. Pommier P, Gomez F, Sunyach MP, Hombers AD, carrie C, Mont- barbo N.

Phase III randomized trial of Calendula officinalis compared with Trolamine for the

prevention of acute dermatitis during irradiation for breast cancer. Journal of

clinical oncology.2004 Apr 15; 22(8):120-25

23. Buzzi M, Freitas F, Winter MB. Pressure ulcer healing with Plenusdermax

Calendula officinalis extract. [Online]. 2016 Mar-Apr; Available from:

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 URL:http://www.scielo.br/scielo.php?pid=S003471672016000200250&script=sciar

ttex& tIng=en

24. Duran V. Results of the clinical examination of an ointment with marigold

(calendula officinalis) extract in the treatment of venous leg ulcers. [Online]. 2005;

Available from: URL:pubmed.ncbi.nlm.nih.gov

25. Kaur B. Dixit U. Calendula in healing of extraction wounds in children. [Online].

Available from: URL:jkpractitioner.com>article7

26. Pooja, Priyadarshani. An experimental study to evaluate the effectiveness of aloe

vera gel application on episiotomy wound healing among mothers in early

puerperal period of selected maternity hospital, Jaypur, Rajasthan. International

Journal of Research Trends and Innovation.2018 May 3(5);220-26.

27. Menezes PM. Effectiveness of aloe vera gel versus lavender oil on episiotomy

wound among postnatal mothers in a selected hospital, Mangalore. International

Journal of Nursin and Midwifery Research.2017 4(3); 275-80

28. Athavale VS, Khandalkar SN, Mahawar M, ShettY I, Lad A. A Comparative study

between aloe vera gel dressing and conventional dressing in chronic wounds.

[Online].2017 4(10); Available from: URL:https://www/ijsurgery.com/index.php/isj/

article/view/1858

29. Effectiveness of aloe vera gel in healing of pressure ulcers among patients

admitted at Rajiv Gandhi government general hospital, Chennai. [Online]. 2014

Apr; Available from: URL:http://repository-tnmgrmu.ac.in/9539/1/ 300116314

thenmozhi.pdf

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30. Eghdampour F. The Impact of Aloe vera and Calendula on Perineal Healing after

Episiotomy in primiparous women. [Online]. 2013. Available from:

URL:pubmed.ncbi.nlm.nih.gov

31. Baghdadi M. Rafiei H. Rashvand F. Oveisi S. effect of aloe vera gel, calendula

officinalis ointment & simple prophylactic sacral dressings for pressure injury

development. [Online]. Available from: URL:www.dovepress.com

32. Azvedo J. Is aloe vera effective for wound healing? [Online]. Available from:

URL:cdn.publisher.gn1.link

33. Singh V. Use of aloe vera & turmeric paste as a supplementary medicine in oral

submucosal fibrosis. [Online]. 2019. Available from: URL:pubmed.ncbi.nlm.nih.

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34. Singh N. Effectiveness of aloe vera & antioxidant along with physiotherapy in the

management of oral sub mucus fibrosis. [Online]. 2016. Available from:

URL:pubmed.ncbi.nim.nih.gov

35. Hambire C. Hambire U. Comparative evaluation of 2% curcumin & 2% aloe vera

gel in the management of chronic recurrent oral ulcers. [Online]. 2020 Jun.

Available from: URL:www.informaticsjournals.com

36. Sherafetmanesh S. Ekramzadeh M. Phytotherapeutic effects of aloe vera.

[Online]. Available from: URL:jnsd.tums.ac.ir

37. Efficacy of aloe vera on wound healing & postoperative pain following periodontal

flap surgery. [Online]. Available from: URL:https://www.jorr.org

38. Athavale V. Khandalkar S. Mahawar M. A comparative study between aloe vera

gel dressing & conventional dressing in chronic wounds. [Online]. Available from:

URL:www.ijsurgery.com

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39. Methodology. [Online]. Available from: URL:en.m.wikipedia.org

40. Research approach. [Online]. Available from: URL:www.projectguru.in

41. What is meant by the setting of the study? [Online]. Available from:

URL:www.editage.com

42. Sample size and power. [Online]. Available from: URL:www.iwh.on.ca

43. Six criteria for survey sample design evaluation. [Online]. Available from:

URL:files.eric.ed.gov

44. Patidar V. Research tool and data collection method. [Online] 2015 sep. Available

from: URL:https://www.slideshare.net/vipinpatidar792/research

45. Feasibility study. [Online]. Available from: URL:en.m.wikipedia.org

46. Data collection definition. [Online]. Available from: URL:www.questionpro.com

47. Data analysis. [Online]. Available from: URL:ori.hhs.gov

80
ANNEXURES

81
ANNEXURE-A

82
ANNEXURE-B

83
84
85
 ANNEXURE-C

LETTER REQUESTING PERMISSION FOR VALIDATION OF RESEARCH TOOL

(Principal’s Letter)

To,

----------------------------------------------

----------------------------------------------
Subject: - Content validity of Research Tool

Respected Sir / Madam,

Ms. Komal Prabhakar Petkaris a bonafide post graduate student
studying in our College of Nursing, Wanless Hospital, Miraj Medical Center, Miraj.
He has selected the below mentioned topic for her dissertation to be submitted to
Maharashtra University of Health Sciences, Nashik as a requirement of M.Sc (N) Nursing
Programme.

TOPIC: - “A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF

CALENDULA OINTMENT VERSUS ALOE VERA GEL ON EPISIOTOMY WOUND
AMONG POSTNATAL MOTHERS ADMITTED IN SELECTED HOSPITALS”.

Regarding the study she is in need of expert opinion and suggestions to validate the
research tool. I kindly request you to provide her necessary co-operation regarding the
same.

Thanking You
Yours sincerely,

86
 ANNEXURE-D

LETTER REQUESTING PERMISSION FOR VALIDATION OF RESEARCH TOOL

(Student’s Letter)

To,

----------------------------------------------

----------------------------------------------

Subject: - Request for opinion & suggestions to establish content

validity of research tool

Respected Sir / Madam,

I, Ms. Komal Prabhakar Petkar. Final Year MSc. Nursing
student of College of Nursing, Wanless Hospital, Miraj Medical Center, Miraj have
selected the topic mentioned below for my dissertation to be submitted to Maharashtra
University of Health Sciences, Nashik in partial fulfillment as a requirement for M.Sc (N)
Nursing Programme.

TOPIC: - “A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF

CALENDULA OINTMENT VERSUS ALOE VERA GEL ON EPISIOTOMY WOUND
AMONG POSTNATAL MOTHERS ADMITTED IN SELECTED HOSPITALS”.

I kindly request you to go through the items and give your valuable opinion and
suggestions to develop the content validity of the tool. Please suggest modifications,
additions and deletions if any.

I have hereby enclosed the following:

1. Research proposal.
2. Data collection tool.

Thanking You Yours sincerely

87
 ANNEXURE-E

CERTIFICATE OF VALIDATION OF RESEARCH TOOL

This is to certify that the research tool selected by Ms. Komal Prabhakar Petkar. Final
Year M.Sc Nursing student of College of Nursing, Wanless Hospital, Miraj Medical
Center, Miraj.

Title: - “A COMPARATIVE STUDY TO ASSESS THE EFFECTIVENESS OF

CALENDULA OINTMENT VERSUS ALOE VERA GEL ON EPISIOTOMY WOUND
AMONG POSTNATAL MOTHERS ADMITTED IN SELECTED HOSPITALS” to be used
in his study has been submitted for content validity.

I have gone through the contents of the data collection tool, enclosed herein in
terms of its relevance and have given my suggestions for the tool.

I have found it to be valid / not valid for conducting the research.

Overall remark:-

Date:-

Place:-

Signature of the Expert:

Name of the Expert: -

Designation of the Expert:-

88
 LIST OF EXPERTS WHO VALIDATE TOOL

SR. NAME OF THE EXPERT DESIGNATION HOSPITAL/COLLEGE

NO.
1. Dr. Mrs. Mangala Rajput. M.D, D.G.O.,Professor. Wanless Hospital,
Department of Obgyn. Miraj

2. Dr. Mrs. BhagyashreChitale. MBBS, MS, Sr. Consultant. Wanless Hospital,

Department Of Obgyn. Miraj
3. Dr. Somashekhar Patil. M.D, D.G.O Somashekhar Hospital, Miraj
Department of Obgyn.

4. Dr.Kedgaokar P.hD. H.O.D Vasantdada Patil Ayurvedic Medical

College, Sangli

5. Dr. Mr. Satish Kakade. Associate Professor. Krishna Institute College of Nursing,
Department of Statistician. Karad.

6. Dr. Jyoti A. salunke Professor & Dean Krishna Institute College of Nursing,
Department of Obgyn. Karad.

7. Ms. Jessey J. Jacob Associate professor & HOD of Samarth Nursing College BKL
Obgyn. Walawalkar Hospital, Dervan.

8. Mrs. Archana Dhanawade. Associate Professor. Bharati Vidyapeeth Deemed

Department of Obgyn. University College of Nursing, Sangli.

9. Mrs. Vijaya Kale Associate Professor Bharati Vidyapeeth Deemed

Department of Obgyn University College of Nursing, Sangli.

10. Mrs.Nitanjali Patil. Associate Professor. Krishna Institute College of Nursing,

Department of Obgyn Karad.

11. Ms. Soniya Bhore. Lecturer. Gulabrao Patil College of Nursing,

Department of Obgyn. Miraj.

12. Mrs. Padma Associate Professor. MINS college of nsg, Latur.

Department of Obgyn
13. Mrs. Laxmi Lecturer. Krishna Institute College of Nursing,
Department of Obgyn. Karad.

14. Mrs. Vishranti B. Giri Lecture College of nursing GMCH,

Department of Obgyn Aurangabad.
89
 ANNEXURE-F

CRITERIA CHECKLIST FOR EVALUATION OF TOOL REQUESTING SUGGESTION

AND OPINIONS FROM EXPERTS

Dear Sir/Madam,
Kindly go through the tool and give your response in the criterion table against
each section. I request you to kindly give your valuable suggestion on the content of the
tool. I also request you to give your expert comments on tool you agree/ disagree which
will help in modification of the tool.

SR. CONTENT RELEVANT ORGANIZED MEASURABLE REMARK

NO APPROPRIATELY
Agree Disagree Agree Disagree Agree Disagree

1. Section I-
Socio
demograp
hic
Variables

2. Section II-
REEDA
SCALE
and
modified
observatio
nal
Checklist
(REEDA
Scale)

90
ANNEXURE-G

91
 ANNEXURE-H

CONSENT OF PARTICIPANTS (ENGLISH)

Code no:

Dear subject,

I Ms. Komal Prabhakar Petkar postgraduate student of Maharashtra

University of health sciences, Nashik. As a part of my study I am doing research on, “A

comparative study to assess the effectiveness of calendula ointment versus aloe

vera gel on episiotomy wound among postnatal mothers admitted in selected

hospitals”.

I assure you that the information collected will be used for my research purpose

only & will be kept confidential. The successful completion of the study largely depends

on your cooperation & participation.

ThankingYou

Yours faithfully,

Consent form of the participant.

I hereby give my consent for the above said study knowing that all the information

provide to me would be treated with utmost confidentially by the investigator. I have been

explained about this study & i am willing to participate.

Signature of the Subject.

92
 ANNEXURE-I
CONSENT OF PARTICIPANTS (MARATHI

93
94
95
 ANNEXURE-J

RESEARCH TOOL (ENGLISH)

SECTION-I

Date-
Time-
Code No-

INSTRUCTIONS:

1. Please place tick mark [ ] against the most correct response in the space

provided.

2. Answer all the questions.

3. Your answer will be kept confidential.

DEMOGRAPHIC PROFILE

I. Age (in years)

a) 20-24 ()

b) 25-30 ()

c) 31-35 ()

d) 36-40 ()

96
 II. Education

a) Illiterate ()

b) Primary education ()

c) Secondary education ()

d) Graduate ()

III. Type of work

a) Sedentary ()

b) Moderate ()

c) Heavy ()

IV. Parity

a) Primipara ()

b) Multipara ()

97
 SECTION-II

REEDA scale

The REEDA Scale (Redness, Edema, Ecchymosis, Discharge and Approximation) is a

scale for grading the severity of perineal trauma associated with episiotomy or laceration

associated with delivery.

Parameters:

(1) Redness

(2) Edema

(3) Ecchymosis

(4) Discharge

(5) Approximation

Parameters Findings Points

Redness None 0

within 0.25 cm of the incision bilaterally 1

within 0.50 cm of the incision bilaterally 2

above 0.50 cm of the incision bilaterally 3

Edema None 0

Perineal < 1 cm from the incision 1

Perineal and/or vulvar between 1-2 cm from 2

the incision

98
 perineal and/or vulvar, > 2 cm from the incision 3

Ecchymosis None 0

within 0.25 cm bilaterally or 0.5 cm unilaterally 1

Between 0.25 cm to 1 cm bilaterally or 2

between 0.5 to 2 cm unilaterally

> 1 cm bilaterally or > 2 cm unilaterally 3

Discharge None 0

Serum 1
Serosanguinous 2

bloody, purulent 3

Approximation Closed 0

skin separation <= 3 mm 1

skin and subcutaneous fat separation 2

skin, subcutaneous fat and fascial layer 3

separation

Score interpretation:

As per guides and statistician’s suggestion scoring should be equally distributed in

each group it will be easy to assess and analyze the data and with the help of formula

(mean-SD & mean + SD) the scoring is unable to distribute equally in each group & there

will be higher score in category-Healed which is not suitable for study.

To measure the episiotomy wound status REEDA scale was used which has four

categories.

0 - Healed

1-5 - Moderately healed

99
6-10 - Mildly healed

11-15 - Not healed

Total score is 15.

Higher the score, is more severe the perineal trauma

100
 ANNEXURE-K

PROCEDURE OF APPLICATION OF CALENDULA OINTMENT / ALOE VERA GEL

ON EPISIOTOMY WOUND:-

Purpose:

1. To cleanse the perineal skin.

2. To reduce the chances of infection of episiotomy wound.

3. To reduce body odor and improve self-image.

4. To promote the feeling of well-being.

Articles:

A clean tray containing:

1. Kidney tray

2. Big bowl with cotton balls.

3. Gauze pieces.

4. Gloves.

5. Normal saline in a bottle.

6. Sanitary pad.

7. Calendula ointment

8. Aloe vera gel

Procedure:

 Explain the procedure to the mother, the purpose and how she has to cooperate.

 Assemble articles at the bedside or in the treatment room.

 Ask the mother to empty her bladder and wash the perineal area with plain water

before coming for perineal care.

101
  Provide privacy.

 Assist the mother to assume lithotomy position with knees bent and drape the

area using diamond draping method.

 Wash hands and dry with towel.

 Put on gloves.

 Pour normal saline in big bowl.

 Take cotton swab dip in normal saline and squeeze excess solution

into kidney tray.

 Separate vestibule with non-dominant hand and clean vestibule starting from

clitoris to fourchette. For each stroke take new swab.

 Clean episiotomy wound

 Dry episiotomy with gauze pieces.

 Take sterile guaze piece. Take3 cc Calendula ointment/ aloe vera gel in center of

guaze piece & apply over episiotomy wound for one hour thrice a day for three

days.

 Place sanitary pad from front to back.

After care:

 Discard gloves.

 Wash hands.

 Make the mother comfortable.

 Replace articles.

 Record the findings of episiotomy wound

102
 OBSERVATIONAL CHECKLIST TO MEASURE THE EPISIOTOMY WOUND (MODIFIED REEDA SCALE)
Instruction- the investigator will mark (√) in the appropriate box accordingly.
Sr. No Parameters Points Day 1 Day 2 Day 3 Day 4
(Pr-t) (Po-t)
M A E M A E M A E

1 Redness on episiotomy wound 0

1
2
3
2 Edema around episiotomy wound 0
1
2
3
3 Ecchymosis around suture area 0
1
2
3
4 Discharge from episiotomy wound 0
1
2
3
5 Approximation of episiotomy edges 0
1
2
3
O1 O2

KEY: Pr-t (pre-test), Po-t (Post-test), M-Morning intervention, A-Afternoon intervention, E-evening intervention, O-Observation

103
 ANNEXURE-L

MASTER SHEET

Table 1: Assessment of episiotomy wound by REEDA scale in

experimental group ‘A’ (Calendula ointment)

(Pre-test and post-test score)

Sample No. Experimental group ‘A’

Pre-test score Post-test score

1 10 1

2 10 0

3 10 1

4 10 0

5 11 1

6 10 1

7 10 1

8 10 0

9 10 1

10 10 1

11 10 1

104
12 10 0

13 11 0

14 9 1

15 10 1

16 10 1

17 10 0

18 10 1

19 10 1

20 10 0

105
 Table 2: Assessment of episiotomy wound by REEDA scale in
experimental group ‘B’ (Aloe vera gel)
(Pre-test and post-test score)

Sample No. Experimental group ‘B’

Pre-test score Post-test score

1 10 1

2 9 1

3 10 0

4 10 1

5 10 0

6 9 1

7 10 1

8 10 1

9 10 1

10 10 0

11 10 1

12 9 0

13 10 1

14 9 1

106
15 9 1

16 10 1

17 10 1

18 10 0

19 10 1

20 11 1

107
 ANNEXURE-M

ABBRIVATIONS

1. REEDA- Redness, Edema, Ecchymosis, Discharge, Approximation

2. O- Observation

3. X- Intervention

4. H- Hypothesis

5. H0- Null hypothesis

6. H1- Research Hypothesis

7. ƒ- Frequency

8. %- Percentage

9. n- Total population

10. SD- standard deviation

11. Pr-t (pre-test

12. Po-t (Post-test)

13. M-Morning intervention

14. A-Afternoon intervention

15. E-Evening intervention

16. O-Observation

17. r-Reliability

18. S.D- Standard deviation

19. t-Test statistic

20. p-Probability

108
ABSTRACT

109
 ABSTRACT

BACKGROUND OF THE STUDY

“Life doesn’t come with a manual. It comes with a mother”.

Episiotomy rates vary widely worldwide, depending on the procedure is used

restrictively/routinely. The worldwide episiotomy rate was 27%-54% are nulliparous and

6% are multiparous women (WHO 2003). In India the birth rate is very high, 56% of

women had an episiotomy compared to the 46% of white women. Midwives have a very

important role to play in the care of perineal wounds following childbirth. Various

intervention are found to reduce episiotomy pain and enhance the healing process which

include administration of analgesics, cleanliness, topical application by dry heat and moist

heat, application of calendula ointment & aloe vera gel, sitz bath performance of kegal

exercise, perineal care and complementary therapies. It is important that midwives

recognize the need for research-based practice in episiotomy care.

OBJECTIVES OF THE STUDY

1. To assess the episiotomy wound among postnatal mothers in both the

experimental groups.

2. To assess the effectiveness of calendula ointment on episiotomy wound among

postnatal mothers in experimental Group A.

3. To assess the effectiveness of aloe vera gel on episiotomy wound among

postnatal mothers in experimental Group B.

4. To compare the effectiveness of calendula ointment versus aloe vera gel on

episiotomy wound among postnatal mothers in both the experimental groups.

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RESEARCH METHODOLOGY

The study was conducted in postnatal wards of selected Maternity Hospital by

using Experimental two group pre-test post-test research design. The quantitative

evaluative approach was considered most appropriate for this study. A purposive

sampling technique was used to obtain a sample of 40 postnatal mothers (20 postnatal

mothers in experimental group A and 20 postnatal mothers in experimental group B). Pre-

test was done in both the experimental groups using REEDA scale. Calendula ointment

and aloe vera gel was applied for both the experimental groups at the interval of 6 hours a

day (3 times a day) for 3 days. The post test was done on 4th day in both the experimental

groups using REEDA scale. The reliability for the research tool of observational checklist

was elicited by using Inter-rater reliability test (r=0.97) which is highly reliable. Data was

calculated using paired and unpaired ‘t test.

RESULT

The result shown that a mean difference was 0.65 ± 0.75. Hence, there was no

significant difference between the effectiveness of calendula ointment versus aloe vera

gel (t=0.68 with p value >0.001).

CONCLUSION

The study concluded that after application of Calendula ointment and Aloe vera gel

episiotomy wound healing was improved in both the experimental groups. Both calendula

ointment and aloe vera gel was effective on episiotomy wound.

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CERTIFICATE OF GUIDE

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AUTHORSHIP DECLARATION

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