A STUDY TO ASSESS THE EFFECTIVENESS OF SOYA MILK IN REDUCING

MENOPAUSAL SYMPTOMS AMONG MENOPAUSAL WOMEN

IN SELECTED RURAL AREAS,
HYDERABAD, TELANGANA”.

BY
NOOLU TANMAI
Dissertation submitted to the
Dr. KNR UNIVERSITY OF HEALTH SCIENCES,WARANGAL
TELANGANA
In partial fulfillment of the requirement for the degree of
MASTER OF SCIENCE IN NURSING
IN
OBSTETRICS & GYNECOLOGICAL NURSING
Under the guidance of
Mrs. M. SHAHNAZ, M.Sc (N), MDHM
Principal
HOD of Obstetrics & Gynecological Nursing

OWAISI COLLEGE OF NURSING, HYDERABAD, TELANGANA

 CERTIFICATE BY THE PRINCIPAL

Certified that this is the bonafide work of MRS NOOLU TANMAIat Owaisi College of
Nursing, Hyderabad, submitted in partial fulfillment of the requirement for the Degree of
MASTER OF SCIENCE IN NURSING from DR K.N.R university of health sciences
Warangal T.S..

Place: PRINCIPAL,

Date : Mrs. M.SHAHNAZ,

M.Sc (N), MDHM
principal,
HOD of Obstetrics and
Gynecological Nursing,
Owaisi College of Nursing,
Hyderabad, T.S.
 CERTIFICATE BY THE GUIDE

Certified that this is the dissertation entitled “Effectiveness of soyamilk in reducing

menopausal symptoms among menopausal women in selected rural areas, Hyderabad,
Telangana.” is a bonafide research work done by Mrs. Virgin James in partial fulfillment of
requirement for the Degree of Master of Science in Nursing.

Place: Hyderabad Signature of the guide

Date: Mrs. M.SHAHNAZ,

M.Sc (N), MDHM
principal,
HOD of Obstetrics and
Gynecological Nursing,
Owaisi College of Nursing,
Hyderabad, T.S.
 DECLARATION BY THE CANDIDATE

I hereby declare that this Dissertation entitled “A study to Assess the Effectiveness of soya
milk in reducing menopausal symptoms among menopausal women in selected rural
areas , Hyderabad, Telangana .”is a bonafide and genuine research work carried out by me,
under the guidance of Mrs. M. Shahnaz, Vice Principal, Department of Obstetrics and
Gynecological Nursing, Owaisi college of Nursing, Hyderabad, Telangana .

Regd No

Place: Hyderabad Signature of the candidate

Date: NOOLU TANMAI
 ENDORSEMENT BY THE EXAMINERS

This is to certify that the dissertation entitled, “A study to Assess the Effectiveness of soya
milk in reducing menopausal symptoms among menopausal women in selected rural
areas , Hyderabad, Telangana .” is a bonafide research work done by Mrs. Noolu Tanmai
M.Sc (N) II year, under the guidance of
Mrs. M.Shahnaz, Principal, Department of Obstetrics and Gynecological Nursing, Owaisi
College of Nursing, Hyderabad, Telangana.

INTERNAL EXAMINER: EXTERNAL EXAMINER:

Name: Name:

Signature: Signature:
 ACKNOWLEDGEMENT

I raise my heart with profound gratitude to Lord Almighty for guidance,

strength and wisdom which was bestowed upon me at every step throughout this
endeavor and for the successful completion of this study.

I am immensely thankful to Management of Owaisi College of Nursing Hyderabad,

for giving me an opportunity to undertake the post graduation course in this esteemed institution
and to conduct the study.
My sincere and whole heartfelt gratitude is expressed to respected principal and
guide to Mrs.shainaz . M.Sc. (N), professor, Head of Department of Obstetrics and
Gynaecological Nursing, for her valuable guidance and enlightening ideas and unceasing
motivation, willingness to help at all times with unlimited patience, encouragement, and
empathy for the successful completion of my research work.

My Heartfelt Thanks to Mrs. Karuna kumari M.S.C (N), associate professor obstetrics
and gynaecological nursing, for her valuable suggestions, timely help, constant guidance, and
her willingness to help all the time.

I extent my deep sense of gratitude to all faculty members of owaisi college of nursing
Hyderabad, for their constant guidance, valuable suggestions and helpful support during the
study.
I would like to extend my gratitude to all experts, who have validated the questionnaire
for their judgment, constructive criticism and enlightening suggestions.
I extend my sincere thanks to Mr. D Krishna kishore , M.Sc., Assistant Professor of Bio-
Statistics, Osmania university , for his guidance and suggestions in validating the tool
and statistical analysis of data.

I extend my sincere thanks to Dr. Medical Officer Rural Health center , Hassan agar
Hyderabad , for their co-operation and support

With folded hands i extended my deep sense of gratitude to my parents

Mr. Noolu uday bhasker rao, Mrs. Noolu Nirmala whose loving arms, care comforts
support, guidance, unending reward less love, pampers in each and every step of my life, which
has brought me to this stage.
 My deepest gratitude goes to my husband Mr. P .Srikanth and My family members
for their unflagging love and support, throughout my life. I will be grateful for having them.

It is my privilege to salute my esteemed college owaisi college, of nursing for grooming me

into post graduate nurse.
I wish to extend my thanks to All My Friends and Classmates for their help and continuous
support.
 ABSTRACT

Background of the study

Menopause may be viewed as transition from middle age to old age. Although menopause is a
universal experience for women. There is no fixed pattern and no chains of events, the onset
and end are unpredictable. .

The word menopause is derived from a Greek word ‘men’ which means ‘month’ and ‘Pause’s’
which means ‘cessation’ (Leon 1990). Menopause means permanent cessation of menstruation
at the end of reproductive life due to loss of ovarian follicular inactivity. it is the point of time
when last and final menstruation occurs .

. The most common and Noticeable symptoms of menopause is hot flush and sweating are the
hall mark of the Cliecmteric in 85% of women other symptoms include severe sweating head
ache disturbed sleep Aginal pain, lack of concentration, phobia, dry vagina loss of libido
urinary symptoms like Dysuria,. stress Incontence , recurrent infection etc.

The conventional treatment for menopause is Hormone replacement therapy. While hormone
therapy (HT) can effectively address many of the symptoms of menopause, women who are
unwilling or unable to take hormonal therapy need non hormonal alternatives for treatment of
menopausal symptoms. When symptoms appear in menopause, many women look to the
natural world for help .Soya is considered as “super food” for relieving menopausal
symptoms because soya bean contains hormones phytoestrogen (phyto means plant) that
mimics the action of natural female oestrogen
.
The present study was carried out to assess the effectiveness of milk consumption in
reducing menopausal symptoms among menopausal women in selected rural areas
Hyderabad ,T.S

OBJECTIVES OF THE STUDY

 To assess the pre test level of menopausal symptoms among menopausal women in
experimental and control group.
 To administer soya milk to the menopausal women in the experimental group.
  To assess the effectiveness of soya milk in reducing menopausal symptoms among
experimental group
 To find out the association between pre test level of symptoms with selected demographic
variables

Methodology
The conceptual framework of the study was developed on the basis of Kenny’s open
system model. The study variable was administration of Soya milk and Hypotheses were
formulated.

The research approach was quantitave approach, experimental study pretest post test control
group design was used to achieve the objectives of the study .the data collection was done
for the period of three weeks . The ethical clearance was obtained from the research
committee
of the owaisi college of Nursing, Hyderabad and the formal permission to conduct the
study was obtained from Medical officer , primary health centre of Hassan agar, Hyderabad

The investigator has used non probability convenient sampling technique to select the samples from
the total population. 60 menopausal women who satisfied the inclusion and exclusion criteria were
assigned in 30 in experimental group and 30 in control group. pretest was collected by using green
clicemetric menopausal rating scale for both the groups. Experimental groups received intervention
of 100ml soya milk twice daily for three weeks . no intervention was given to control group.post test
was conducted by the researcher for both groups by using same menopausal rating scale on first
day of fourth week.
 TABLE OF CONTENTS

CHAPTER CONTENT
NO
I INTRODUCTION 1-2
 Need for the study 3-4
 Conceptual frame work 5-6
 Problem Statement -8-
 Objectives -8-
 Operational Definitions -8-
 Hypothesis -9-
 Assumptions -9-
 limitations -9-

II REVIEW OF LITERATURE
 Literature related to prevelance of menopausal -11-
symptoms.
-12-
 Literature related to incidence of management of
menopausal symptoms
12-13
 Literature related to effect of soya foods in reducing
menopausal symptoms. 13-14

RESEARCH METHODOLOGY
14-16
III  Research Approach
 Research Design 16-17
  Description of Variables
 Settings
 Population -19-
 Sample and Sampling techniques -19-
 Criteria for Sample Selection -22-
 Method of Data Collection -22-
 Development and Description of Tool -23-
 Validity of the Tool -23-
 Reliability of the Tool 23-24
 Pilot Study -24-
 Data collection procedure -24-
 Plan for Data Analysis -26-
 Epilogue -26-
-26-
ANALYSIS AND INTERPRETATION
-27-
 Sample Characteristics
IV 27-28
 Comparison of pre-test and post-test knowledge Scores
-28-
 Mean and Standard Deviation of knowledge scores with
pretest and post test
30-70
 Chi-Square value association between knowledge score
of women with selected Demographic Variables

EPILOGUE FINDINGS, CONCLUSION,

DISCUSSION,IMPLICATIONS, LIMITATIONS &
V RECOMMENDATIONS
 Epilogue findings
 Conclusion
 Discussion
 Implications
72-75
 Recommendations
-75-
 Limitations
-75-
76-78
BIBLIOGRAPHY
-78-
VI
ANNEXURES
VII

79--

List of tables

Frequency and percentage distribution of demographic variables of

women with menopausal symptoms in Control and Experimental
group.

Frequency and percentage distribution of severity of menopausal

symptoms in Control and Experimental group before and after soya
milk consumption

Comparison of Mean and Standard deviation of Menopausal

symptoms among menopausal women before and after
intervention in Control and Experimental group

Comparison of Mean and Standard deviation of post test

Menopausal symptoms among Women between 45-56years among
Control and Experimental group.

Association between post test scores of menopausal symptoms with

their selected demographic variables in control group.

Association between post test scores of menopausal symptoms with

their selected demographic variables in Experimental group.
Conceptual framework based on Kenny’s open system
model.

Schematic Representation of the Research design

Percentage distribution of occupation of women with

Menopausal symptoms.

Percentage distribution of type of family of women with

Menopausal symptoms

Percentage distribution of dietary pattern of women with

Menopausal symptoms
Percentage distribution of marital status of women with
Menopausal symptoms

Frequency and Percentage distribution of severity of

Menopausal symptoms in control and Experimental group
before soya milk consumption

Frequency and Percentage distribution of severity of

Menopausal symptoms in control and Experimental group
after soya milk consumption
Letter seeking experts opinion for Content Validity

List of experts

Certificate of Content Validity of the tool

Letter seeking permission for conducting Pilot study

Letter seeking permission for conducting Main study

Certificate for English Editing

Certificate for Hindi editing

Certificate for Telugu editing

Certificate from Statistician

Research Participants Consent Form

Tool in English

Tool in hindhi

Tool in telugu

Data code sheet

Master code sheet

 Chapter _I
INTRODUCTION
INTRODUCTION

“WOMEN ARE THE LARGEST UNTAPPED RESERVIOR OF TALENT IN WORLD.”

Being a women is very special. Nature takes her through a series of transition in their life
starting from birth to death Changes in health illness of individuals create a process of
transition. The women experiences the process of transition mainly in their reproductive age,
the years of life between menarche and menopause roughly from 12to 49.

Adolescence is a transition period from child hood to adult hood and is

characterized by spurt in physical endocrinal and emotional and mental growth . one of the
major physiological change is onset of menarche, the first menstrual period. It usually starts
between the age of 11to14years of age. The onset of menstruation follows a cycle for every 28
days and the duration lasts from 3-5days. In these days may feel tense, gain water weight ,feel
bloated ,pain in the abdomen ,back or legs that lasts for few hours to days.

Menopause may be viewed as transition from middle age to old age. Although menopause is a
universal experience for women. There is no fixed pattern and no chains of events, the onset
and end are unpredictable. .

The word menopause is derived from a Greek word ‘men’ which means ‘month’ and ‘Pausis’
which means ‘cessation’ (Leon 1990). Menopause means permanent cessation of menstruation
at the end of reproductive life due to loss of ovarian follicular inactivity. it is the point of time
when last and final menstruation occurs .

The age of menopause ranges between 45-55 years average being 50 years. In developed world
, life expectancy for women since 1990 has increased from 51 to 81 years the life expectancy
of the population around the world the life expectancy of the population around the world is
estimated to be 75- 80 years. There are about 37.5 million women reducing or currently at
menopause. There are average of menopause is 5 years, how ever there wide age distribution
ranges from 45- 58 years, around the world, studies have shown that about 75% of women
experiencing menopause will hot flushes. In India already crossed the billion mark with
71millon people over 60 years of age and the number of menopausal women about 43 million.
Average age of menopause 47.5 years in Indian women with an average life expectancy of 71
years.

The most common and Noticable symptoms of menopause is hot flush and sweating are the
hall mark of the Cliecmteric in 85% of women other symptoms include severe sweating head
ache disturbed sleep Aginal pain, lack of concentration, phobia, dry vagina loss of libido
urinary symptoms like Dysuria,. stress Incontence , recurrent infection etc.

Soya bean is a species of legume native to east Asia widely grown for its edible bean,
which has numerous uses. Soya bean is a primary high source of protein fats carbohydrates
vitamins and minerals it contains 43gms of protein per 100gm which is the highest among
pulses soya bean also contain a family of chemical compounds called Phyto estrogens have
chemical structure, similar to the estrogen produced in the body and it is believed that eating
foods rich in Pyhto estrogens can help alleviate low estrogen production. Iso flavones are the
active ingredient in soy bean which have estrogen like properties eating 10gm of soya protein
provides 200mg of soy Iso flavones. A target range 80-160 mg of Iso flavones per day is needed
for menopausal symptoms.

Researchers have founded that women in Japan and the other Asian countries who eat
35 to 45 milligrams of plant estrogen a day in the form of tofu soya milk and other soy products
seems to experience fewer hot flash, the study revealed by the department of family medicine
and community health at university school of medicine in boston.
NEED FOR THE STUDY

Menopause is a normal stage of life experienced by women all over the world. Menopause
means permanent cessation of menstruation due to the loss of ovarian follicular the clinical
diagnosis is confirmed following stoppage of menstruation for twelve consecutive months with
out any other pathology

The stages of menopause have been classified in to premenopausal post menopausal and peri
menopausal period. Premenopausal is the part of the Clicemetric before menopause, when the
menstrual cycle is likely to irregular. Post menopause is the phase of life that comes after the
menopause

The age of menopause ranges between 45-55yearsaverage being 50 years. The median age at
menopause in Europe ranges from 50.1 t0 52.8 in north America from 50.5 to 5i.4 in Latin
America the prevalence of such symptoms varies widely from geographical area selection of
criteria and method of system of identification.

Menopause is said to be universal reproductive phenomenon which can be perceived as

unpleasant this period is generally associated with un avoidable manifestation of aging process
in women. Menopause may be smooth of Cessation of menstrual flow while others face one
or more of menstrual symptoms like

Vasomotor symptoms : hot flashes, night sweating, heart discomforts

Joint and muscular discomforts, dry and itchy skin , Palpitations interrupted sleeping problems

Psychological symptoms: depression irritability, lack of concentration memory Disorder

insomnia ,mood swings, In ability to concentrate

Urogenital symptoms :vaginal dryness, dyspareunia ,atrophic vaginitis genital and urinary
tract infections

Although menopause is a natural process almost all women during and after menopause suffer
from typical symptoms with approximately 40% seeking a medical help for various symptoms
vasomotor urogenital musculoskeletal symptoms. Recent studies failed to show the protective
effect of hormonal therapy in reducing the risk of coronary artery disease and have reveled an
increased risk of heart disease , stroke and invasive breast cancer. Certain foods which are in
estrogen supplements helps in reducing the menopausal symptoms mainly hot flashes.

The dietary supplement like soya beans, wild yam and vitamin e like green leafy vegetables
nuts and almonds as well as plenty of mineral and fiber rich foods, like whole grains and fresh
vegetables and water helps in reducing menopausal symptoms like, hot flushes soya contains
special chemicals known as phyto chemicals that seems to fight against illness and diseases.
Phyto estrogen , a special kind of Phyto chemical appear Ii high quantities in soya products.
These Phyto estrogens are a weaker form of our own natural estrogen, and seem to help combat
the symptoms of menopause.

A recent study under taken in the areas urban field areas of osmania medical college of
Hyderabad on postmenopausal women .the aim of the study is to determine the prevalence of
various menopause related health problems and their relationship with socio demographic
biological and life style pattern. The materials methods were 430 postmenopausal women were
interviewed using pre designed and biologic and lifestyle variables. Menopause related health
problems were enumerated using modified menopause rating scale. The prevalence of any of
the somatic problems wer77%, any of the psychological problems were 37.4%urogenital
problems were 32.1%. There was statistically significant association of age parity, duration of
menopause . The study concluded menopausal health problems need to be addressed as it poses
a major public health problem and are also amenable for preventive strategies to reduce
menopausal symptoms.

Many studies have recommended the use of harmone replacement therapy for the treatment of
menopausal symptoms . Recent studies have revealed that harmone replacement therapy
increased the risk of stroke, breast cancer coronary artery disease . so there is need of natural
approaches to relieve symptoms such as use of herbs, lifestyle modifications and dietary
changes. Some of studies recommended use of soya in reducing menopausal symptoms

A pilot study has been conducted among post menopausal women in reducing menopausal
symptoms residing in selected rural community village bangalore . The aim of the study to
evaluate the effects of soya milk on menopausal symptoms. An evaluative approach with true
experimental pretest post test control group design with random assignment was used . They
were two groups in the study experimental and control group . data was collected using
demographic proforma , menopause rating scale and menopause specific quality of life
questionnaire. Experimental group was given daily supplements of 200 ml of home made soya
milk for a period of six weeks . control group participants did not receive any intervention.
Data collected was analyzed and study results revealed that the experimental group which
received soya milk showed significant difference in the reduction in MRS score (p<0.001) and
MENQOL scores ( p<0.0001)

The researcher has observed that menopausal symptoms affect the quality of life of menopausal
women and felt that there is an effect of soya milk consumption among menopausal symptoms
. considering the above factors, there is a need of study soya milk consumption among
menopausal women.

Conceptual Framework
Conceptual framework deals with abstractions (concepts) that are assembled by virtue of their
relevance to a common theme. Conceptualization is a process of forming ideas which is utilized and
forms conceptual frame for development of research design. It helps the researcher by giving direction
to go about entire research process.

Conceptual frame work facilitates communication and provides for a systematic approach to nursing
research, education, administration & practice.

KENNY’S OPEN SYSTEM MODEL

The study is based on KENNY’S OPEN SYSTEM MODEL. All the living systems are open, in that
there is continuous exchange of matter, energy information.

Open system has changing degree of interaction with the environment from which the System
receives input and gives back out put in the form of matter, energy and information. For survival, all
systems of nursing receive varying type and amount of matter, energy and information.

The main concept of open system model is: Input, Through Put, Output and Feedback. In open system
theory input refers to matter, energy and information that are processed. After processing the input the
system returns to output (matter, energy and information to the environment in an altered state).
Feedback refers to environment response to the systems output used by the system in adjustment
correction and accommodation to the interaction with the environment.

The study is under taken to determine the effect of soya milk consumption on menopausal symptoms

Pre test conducted to assess the symptoms of menopause like hot flushes, sleeplessness, night sweats
etc.

Input – Providing soya milk for reducing the menopausal symptoms.

Through put – Through put is the process of soya milk consumption on menopausal symptom among
women who consumed soya bean.
Post test – Again assessing the symptoms of menopause.

Out put – Refers to effect of soya milk consumption on menopausal symptoms by post test
 INPUT THROUGHPUT OUTPUT

Control group
Assessing the Menopausal
No intervention
menopausal not reduced
P
symptoms
p o
among
r s
menopausal
e t
women Process of
t t
e consumption of e Menopausal
s Experimental group soya milk s symptoms
t administering 100ml t reduced
soya milk twice daily for
three weeks
PROBLEM STATEMENT

A STUDY TO ASSESS THE EFFECTIVENESS OF SOYA MILK CONSUMPTION IN

REDUCING MENOPAUSAL SYMPTOMS AMONG MENOPAUSAL WOMEN IN

SELECTED AREAS AT HYDERABAD T.S.

OBJECTIVES OF THE STUDY

 To assess the pre test level of menopausal symptoms among menopausal women in
experimental and control group.
 To administer soya milk to the menopausal women in the experimental group.
 To assess the effectiveness of soya milk in reducing menopausal symptoms among
experimental group
 To find out the association between pre test level of symptoms with selected demographic
variables

OPERATINAL DEFINITIONS

ASSESS: it refers to measuring the level of symptoms among menopausal women

EFFECTIVENES: it refers to the level of reduction of menopausal symptoms after the oral
consumption of soya milk among menopausal women as measured by using modified menopause rating
scale

SOYA MILK ; it refers to the solution which is prepared which is prepared from soya bean soaked
for 12- 14 hours, blending , straining the milk, and then boiling the milk at 100cand administered a
twice day per three weeks

MENOPAUSAL SYMPTOMS ; it refers to rating the severity symptoms, night sweats, hot flushes, sleep
disturbances fatigue vaginal dryness, depression, headache, irritability, muscle joint pain, breast
tenderness, nervousness, palpitations and dizziness / fainting

MENOPAUSal women ; in this study refers to women with natural menopause at age of 45years.
ASSUMPTIONS

 Menopausal women above 45 years may experience menopausal symptoms

 Soya milk consumption may reduce menopausal symptoms
 Reduction of menopausal symptoms may improve quality of life

DELIMITATIONS

 The study is limited for 6 weeks

 The study is limited to 60 samples
 The study is limited to menopausal women at selected rural areas Hyderabad.

HYPOTHESIS

H1: There will be significant difference between the level of menopausal symptoms and after soya milk
consumption experimental group.

H2: There is a significant difference between the post level of menopausal symptoms among
experimental and control group.

H3 :There is a significant association between the pre test level of menopausal symptoms and selected
demographic variables among experimental and control groups
CHAPTER –II
REVIEW
OF
LITERATURE
REVIEW OF LITERATURE

The review of literature has been arranged in the following section

1. Literature related to prevalence of menopausal symptoms

2. Literature related to management of menopausal symptoms
3. Literature related to effect of soya foods on menopausal symptoms

LITERATURE RELATED TO PREVALENCE OF MENOPAUSAL SYMPTOMS

NABAURN KARMKAR ET AL 2017 ; A descriptive cross sectional study 100 peri

menopausal women (40-60 years) in Dearah village of west Bengal , India during February – march
2014 the menopause specific quality of life questionnaire the study findings were occurrence of
vasomotor symptoms was average with 60%of them reporting hot flashes and 47% sweating. Most
prevalent psychosocial symptoms reported were feeling of anxiety and nervousness (94%) and over all
depression (88%). Physical symptoms were quite varying in occurrence with some symptoms such as
feeling tired 40% reported of avoiding intimacy with a partner and 26% complained vaginal
dryness.The study concluded most of prevalent symptoms are psycho social symptoms

AL DAUGHTER 9(2015) ; A cross sectional study was conducted on menopausal women. The study
aimed to assessment of women for symptoms. The samples were women aged 45-60 years. the methods
used randomized interview . The menopause rating scale assessed the prevalence and severity of eleven
menopausal symptoms. The study concluded that the most prevalent symptoms were joint and muscle
pain (80.7) physical and mental exhaustion (64.7%)and hot flushes and sweating (47.1) the mean over
all quality of life score was higher in peri menopausal women compared to other groups.

BRONS LAW 2014; a study was conducted to assess the life style of women during menopause.
The study aims to find the problems occur during menopause and solution to solve the problems. The
material and methods used were diagnostic survey and non standardized questionnaire developed by
authors. The sample were 100 women among the age group 40-60 years. The study concluded that
among menopausal women one can observe hot flashes head aches insomnia irritability. To avoid this
problems during menopause the women can try to assume a proper diet , rest, physical activity
LEENA SOUZA ANITHA C RAO(2011), A study conducted on health problems of menopausal
women in Karnataka. The objective of the study was to determine the presence of health problems
among the menopausal women in selected in selected areas of Udupi, Karnataka, by using a structured
interview the study revealed tat majority of menopausal women in urban area joint pains hot flashes
(68%) and psychological problems like forget fullness (25%) in ability to concentrate (27%) . the study
concluded that vasomotor symptoms are most prevalent among menopausal women

AROAN R MULIYALI (2009) ; A cross sectional study was conducted on peri menopausal
and post menopausal women residing in rural areas of south India. The aim of the study is to determine
perceptions regarding menopause and prevalence of menopausal symptoms and association of family
environmental factors with menopausal symptoms . The sample used were 100 postmenopausal and
100 peri menopausal women. The methods used were structured questionnaire. The study findings
revealed that 69% of complained of diminishing abilities after menopause. 23% felt that sexual life ends
with the onset of menopause, 16%reported that their husbands had become disinterested in them after
menopause and 11% were apprehensive about loss of feminity. A higher proportion of menopausal
symptoms reported hot flushes, night sweats, urge incontinence and other somatic symptoms. The study
concluded that there was significant association between multiple symptoms, vasomotor symptoms,
urge incontinence, loss of sexual desire and menopause. There fore it is important to determine the
feasibility and impact of alternative therapies in preventive health care
LITERATURE RELATED TO MANAGEMENT OF MENOPAUSAL

SYMPTOMS

JAMES W CARSON.(2009). A study was conducted . the aim of the study is to assess the

effectiveness of yoga intervention on menopausal symptoms in early-stage breast cancer survivors.

Thirty-seven disease-free women experiencing hot flashes underwent the 8-week Yoga Program
(breathing exercises, meditation and gentle yoga poses). The daily report of hot flashes was gathered at
baseline and 3 months after treatment through an interactive telephone system. The results stated that
women who underwent the yoga program shown greater improvements in reduction of hot flash, joint
paint, fatigue and sleep disturbance in early-stage breast cancer survivors.

DR R CHATTA (2007) ; A study was conducted a randomized control study. The aim of the

study is to investigate whether yoga would help women with physical and cognitive symptoms of
menopause. The methods used were randomized control group.They randomly assigned 120
menopausal women 40-55 years old in New York to yoga practice or simple stretching and
strengthening exercise five days a week for eight weeks. Women in the yoga group also listened to
lectures on using yoga to manage stress and other yoga related topics while those in the control group
heard lectures on diet, exercise, the physiology of menopause and stress. After eight weeks women in
the yoga group showed a significant reduction in hot flashes, night sweats and sleep disturbances while
the women in the control group do not. The study concluded Both groups showed improvements in a
test of attention and concentration although improvement in the yoga group was significantly greater.
REVIEW OF LITERATURE RELATED TO EFFECT OF SOYABEAN CONSUMPTION ON
MENOPAUSAL SYMPTOMS

PADMA PRIYA (2017) A pilot study was done. The aim of the study to assess the feasibility
and to evaluate the effects of soya milk on menopausal symptoms and quality life health post
menopausal women residing in rural area. The methods were 2 An evaluative approach with true
experimental pre test post test control group (n=25) and experimental group (n=25). Data was collected
using demographic proforma , menopausal rating scale and menopause specific quality of life
questionnaire. Experimental group was given daily supplements of 200 ml of home made soya milk for
a period of six weeks. control group participants did not receive any intervention. Data collected was
analyzed based on the objectives and hypothesis of the study. study reveals that experimental group
which received soya milk showed significant reduction of menopause symptoms (p,0.001). The study
concluded there is an effectiveness of soya milk were there is significant reduction of menopausal
symptoms.

REENA WILLIAM FRANK (2015) A study was conducted .The aim of the study to assess the
effectiveness of soya bean consumption in reducing menopausal symptoms .The methods were non
equivalent control group design was performed in 60 menopausal women selected using convenient
sampling. Data was collected using baseline proforma and menopausal rating scale. The pretest
menopausal symptoms were assessed in both groups. Soya bean consumption was given for 21 days for
experimental group and post test was done after 21 days in both groups. In pre test 83.3% oh had mild
symptoms and remaining had moderate menopausal symptoms in both groups. In the post 90% of
women had mild symptoms and 10%had no menopausal symptoms were assessed in both groups there
was significant difference between the pretest and post test score of menopausal symptoms in
experimental and control group. Hence the study concluded that there is an effect of soya bean
consumption significant reduction in menopausal symptoms.

RONBINSON ENOW (2013) ; A prospective multicenter study involved 140

menopausal women with Clicemetric symptoms (minimum of hot flashes and/or moderate to severe
night sweats per day). The aim of the study is to determine the effect of soya iso flavones in reducing
menopausal symptoms. These patients received 40 mg supplement of soy iso flavone contained in an
Inclian capsule the dose was increased to two capsules per day when there are more than five hot flashes

or when the women could not sleep because of night sweats. The patients were followed up over 4
month period and the data was analyzed. The results concluded the effectiveness of pharmaceutical
grade of isoflavone in reducing vasomotor symptoms in menopausal symptoms.

HANACHI P GOLKO (2008) ; A study was conducted . The aim of the study is

to assess the effect of soy phytoestrogens and exercise on lipid profiles and menopause symptoms. The
sample were 37 menopausal women in Iran.37 menopausal women randomly assigned to soymilk
(n=15), exercise and soymilk (n=12) and control group (n=10) which were provided daily for 3 months.
The study findings revealed that excercise and soy supplementation decreased of hot flushes by 83%,
nervousness by 30%, vaginal symptoms by 50% and sexual symptoms by 45%. The study concluded
that the consumption of soymilk and exercise for three months helps for the reduction of menopausal
symptoms.

PARICHER HANACHI(2007) ; A recent study was conducted on 37post menopausal

women were randomly assigned to soya milk(n=15),exercise +soya milk(n=100 the daily milk consisted
of 12.5 g of protein with genistien (13mg)and diadzen (4.13mg). Menopausal symptoms were measured
using kupper man index , a standard measure of clicemetric symptoms that has been validated in
menopausal women at baseline and 3 months of daily consumption of soya milk. total antioxidant status
of serum was measured using ferric reducing ability of plasma assay. Result soy milk supplementation,
soya milk and moderate exercise significantly (p<0.05) improved tac level and tlp activity. Vasomotor
symptoms were improved (p<0.05) in the soy milk consumption plus moderate exercise and soya milk
group as compared with control group, this data concluded that consumptionsoyamilkfor 3 months
enhances antioxidant and t a lp status and reduces menopausal symptoms in post menopausal women

CHENG G WILZECK (2007); A double-blind prospective study was conducted. The aim

of the study is to determine the effect of soya Iso flavone treatment for acute menopausal symptoms.
The sample were sixty healthy postmenopausal women who were randomly assigned by computer into
two groups to receive 60 mg soya iso flavones or placebo daily for 3 months. Climacteric symptoms
were recorded before and after treatment, the study results revealed that hot flushes and night sweats
were reduced by 57% and 43%, respectively. The study concluded that soya iso flavones could be used
to relieve acute menopausal symptoms.
 SHETTY J GUPTA(2006) A prospective study was conducted the aim of the study

to evaluate the efficacy of soy iso flavone on menopausal symptoms as an alternative to Hormone
Replacement Therapy. The sample were 46 menopausal women in Karnataka. The samples were 46
menopausal women requesting treatment for climacteric symptoms and no history of uncontrolled
hypertension. The 12 month program me consisted of supplementation of 75 mg soy iso flavone daily
and the Menopausal Kupperman Index was used to assess change in menopausal symptoms. The study
results revealed that menopausal symptoms were significantly lower (P<.001) than the pre treatment
period (P = 0.02).The study concluded that soy is flavone treatment was safe and effective alternative
therapy for menopausal symptoms.
 CHAPTER –III
METHODOLOGY
 RESEARCH METHODOLOGY
The methodology of research study is defined as the way the data are gathered in order to answer the
question to analyze the research problem. The research methodology involves a systemic procedure
by which the researcher starts from initial identification of the problem to its conclusion.

The present study conducted to assess the effectiveness of soya milk upon menopausal symptoms
among menopausal women. The chapter deals in brief description of different steps undertaken by the
researcher for the study. It includes research design research approach setting of the study sampling
technique, sampling criteria,

Research Approach

According to polit (2008) the research approach refers to a general set of orderly
disciplinedprocedures used to acquire dependable and useful information.

An experimental research is the most significant part of any research. The appropriate choice of the
research approach depends upon the purpose of the research study which is under taken.

To accomplish the objective of this study an xperimental approach is considered most appropriate
since the researcher wanted to assess the effectiveness of soya milk upon menopausal symptoms
among menopausal women.

Research Design

A research design is the overall plan for addressing a research question, includingspecification for
enhancing the study integrity.

The design adopted for this study will be pre test post test control group design. The design uses a
control group in order to determine whether the treatment or intervention will make difference.

Group Pre test intervention Post test

Experimental er O1 X O2
 Control cr 01 02

key

R – Randomization

O1 _ Pre assessment of menopausal symptoms

O2 – Post assessment of menopausal symptoms

X _ Intervention ( administration of soya milk )

E _ Experimental group

C _ control group

An experimental research design was adopted for conducting this study. It fulfills the criteria such as
manipulation, control, and randomization.

Randomization was carried out to select the 30 sample and to assign the control and experimental
group. Soya milk was given as manipulation in experimental group.

In this study pretest, posttest control group design was adopted. The researcher assessed the
prevalence of menopausal symptoms among menopausal women using green clicematric menopausal
rating scale.

Then control and experimental group were selected then manipulated the independent variable that is
soya milk which will administered only to the experimental group. Then the menopausal symptoms
were assessed by rating scale for both groups.
 SCHEMATIC REPRESENTATION OF THE STUDY

Experimental Study

Quantitative Approach

Pre test post test Control Group Design

Target Population Menopausal Women

Accessible Population Menopausal Women With Menopausal Symptoms In Selected Areas Huussanagar

Phase -I sampling technique non probability convenient sampling

Phase –II Data collection 30 menopausal women with menopausal symptoms

Data collection Tool structured questionnaire and green clicematric menopausal rating scale

Experimental Group - 15 Control Group - 15

Pre assessment of menopausal Pre Assessment of menopausal women

symptoms
Administration Of Soya Milk 100ml Routine care of symptoms
For Three Weeks

Reassessment Of Menopausal Symptoms

Data Analysis And Interpretation Through descriptive and inferential Statistics

Report and findings

Research variables:

An abstract concept when defined in term that can be measured is called a variable. Variables are
characteristics that vary among the subject being studied.

POLIT (2008)

Description of variables:

Independent variables:

The independent variable is the variable that stands alone and does not depend on any other. It is the
cause of action.

In this study soya milk administered to menopausal women is the independent variable.

Dependent variable:

Dependent variable is the effect of the action of independent variables and cannot exist by itself (Polit
2008).

The level of menopausal symptoms experienced by menopausal women is the dependent variable in
the study.

Setting of the study

According to Polit (2008) setting refers to physical location and condition in which the data collection
takes place in the study.The study was conducted in Hassan agar Rajendra,nagar. Hassan agar is in
Hyderabad in Telangana state India. It is situated from distance of 1 km from owaisi college of nursing
the rural health center covers the population 30.325 and most spoken language are Urdu Hindi and
Telugu.
POPULATION:

The population is the entire set of individual or object having some common characteristics.

The population for the present study comprised of menopausal Women in selected rural Hyderabad

The target population

It is the group of population that the researcher aims to study and to whom the study finding will be
generalized. In this study the target population for this study comprises of menopausal women at
selected rural area Hassan agar Hyderabad

Accessible population

Is the list of population that researcher finds in in the study area. The accessible population in this
study is menopausal women menopausal symptoms residing in Hassan agar.

SAMPLE:

According to Polit (2008) sample is a subset of a population selection, selected to participate in the
research study

In this study the sample refers to, menopausal women with menopausal symptoms in selected rural
area Hassan agar.

Sample Size:

A sample size of 60 menopausal women between at selected rural area in Hassan agar 30samples will
be assigned for the experimental group and 30 for the control group. .

SAMPLING TECHNIQUE:

Sampling technique refers to the process of selecting a portion of the population to represent the entire
population (polit 2008).

In the present study non probability convenient sampling technique will be used .
In this method subjects are selected convenient Accessibility and proximity of the researcher
(Sharma)

The researcher will select 60 menopausal women ,available and accessible at the time of study.

SAMPLING CRITERIA:

The sample selected was based on the following inclusion and exclusion criteria.

Inclusion Criteria:

 Women who have attained menopause.

 Women who are available at the time of study
 Women who can understand Telugu and Hindi
Exclusion criteria:

 women who have not attained menopause

 women who are not willing to participate in the study

METHODS OF DATA COLLECTION

Data collection is a precise systematic gathering of information, relevant to the research purpose.The
investigator will obtain permission concerned authority . informed consent will be obtained from the
subjects. The study participants will be selected by convenient sampling. The sample will be equally
distributed in experimental and control group. The pretest will be conducted by assessing menopausal
symptoms by green clicematric menopausal rating scale. Soy milk 100ml is administered to them for
three weeks twice daily. The post test will be conducted after three weeks.
Data collection period:

The study will be conducted for the period of four weeks

DEVELOPMENT & DESCRIPTION OF THE TOOLS:

Development of tool:
A structured interview schedule was developed based on the objectives of the study. Various sources
of literature and opinion from the Subject experts are items in the questionnaire. All these helped
ultimately in developing the tool.

Description of the tool:

The instrument used in this study consists of two sections,

SECTION A- Demographic profile: - educational status, religion of menopausal women, it consists

of questions.

SECTION – B green clicematric menopause rating scale

It was developed to measure the frequency of menopausal symptoms. It was developed by geralad
greene. It is like 4-1tem likert type. It consists of 21 items grouped into 3 domains

a) psychological

b) physical

c) vasomotor

PSYCHOLOGICAL

 Feeling tense or nervous

 Difficulty in sleeping
 Excitable
 Attacks of panic, anxiety
 Difficulty in concentrating
 Feeling tired
 Loss of interest in many things
 Feeling unhappy or depressed
 Crying spells
 Irritability
 Disturbing memory lapses
 Sleeping disorder
 Feeling of dread
 PHYSICAL

 Feeling dizzy or faint

 Pressure or tightness of abdomen
 Bloating
 Burning tongue
 Changes in finger nail
 Changes in body order
 Increase in allergies
 Itching and crawly skin
 Reduced skin elasticity
 Increased wrinkling
 Gum problems
 Hair loss
 Increased tension in muscles
 Muscle and joint pains
 Electric shock syndrome
 Weight gain

VASOMOTOR

 Hot flushes
 Sweating at night
 Vaginal dryness
 vaginal itching and irritation
 Loss of interest in sex
 Dyspareunia
 Recurrent urinary tract infection

Each symptom is rated to according to the severity using a four point rating scale.

Scores are assigned as follows

Not at all =o

A little bit =1

Quite a bit= 2

Extremely = 3
VALIDITY OF THE TOOL:

The validity refers to the degree to which an instrument measures what it is supposed to
measure. The content of the tool was validated by one Medical expert, Five Nursing Experts
and one statistical expert. The expert’s suggestions were incorporated and the tool was finalized
and used by the investigator for the main study.

RELIABILITY:

Reliability is the degree of consistence that the instrument or procedure demonstrate. The
reliability of the tool was elicited by using test – retest method. Six menopausal women were
taken as sample and test – retest method was done. The reliability of the tool is r = 0.79, which
was found reliable for the study.

ETHICAL CONSIDERATION:

The proposal of the study was approved by the experts prior to the pilot study by the
Research and Ethics Committee of Deccan medical college kanchanbagh, Hyderabad

PILOT STUDY

Pilot study is a small scale version or trail run for the major study. Its function is to obtain
information of improving the project or for assessing its feasibility. The principle focus is
assessment of the adequacy of measurement. Pilot study was conducted a rural area Bhavani
nagar Hyderabad. Formal consent was obtained from the participants after explaining the
purpose and nature of the study. The tool was administered to 6 menopausal women and pretest
score were obtained. The soya milk 100ml twice daily is was administered after the pre-test
for Seven days. later post test was conducted with same tool to the same group of sample. The
tool and intervention was found to be reliable and understandable to the participants.
DATA COLLECTION PROCEDURE

Data collection is a precise systematic gathering of information, relevant to the research

purpose. The main study was conducted at Hassan agar, Hyderabad. The written permission
was obtained from medical officer of PHC after explaining the nature and importance of the
study and duration of data collection. Total 60 women based on what sampling criteria were
selected for study. The purpose of the study was to assess the effectiveness of soya milk in
reducing menopausal symptoms. The procedure was explained confidentiality and consent was
obtained , from the samples The sample were divided equally 30 into experimental group and 30 into
control group. Pre- test was conducted for both experimental and control group and then the soya
milk 100ml was administered twice daily was given to experimental group for three weeks. Then post
test was conducted after three weeks with the same tool.

PREPARATION AND ADMINISTRATION OF SOYA MILk

The soya bean (Glycine max) belongs to the legume family. Legumes features phyto . Legumes
features phyto nutrients that lend some unique befits to the women in their menopausal stage. The
soya products are highly rich in iso flavones, the most widely studied class of pyto nutrients. Each
gram of soya bean and traditional soya foods provides approximately 3.5mg of iso flavones.

Purposes

 Soy products are good source of protein and has been consumed by Asian populations
 The effects of soy iso flavones observed on physical and physiological symptoms helps to
reduce hot flashes and night sweats.
50 gm of soya contains:

o Phyto estrogen-20 mg
o Energy-20 mg
o Energy-223 cal
o Carbohydrates-10.45gm
o Fat-9.75gm
o Protein -21.6gm
o Vitamin A-1 moq.
o Vitamin B-0.133mg
o Vitamin c-3mg
o Vitamin k- 2.7mg
o Calcium 120mg
o Magnesium -140 mg
PROCEDURE FOR PREPARATION OF SOYA MILK

• Soak 5o gm of soya bean in water the previous night.

• The next day morning blend it and extract of 100ml of soya milk soya milk should be taken
by filtering it in cheesecloth.
• The obtained extract must be boiled at 100c
• After the milk is cooled then it s administered

Intervention protocol

Protocol Experimental group Control group

place Client house in selected Selected house in

areas of Hassan agar hassanagar

Intervention Soya milk 100 ml Routine care

duration Three weeks Three weeks

frequency Twice a day -

Time Morning and night -

Administered Investigator Self

by

Data entry and data analysis

The data were entered in Excel sheet and completed in two weeks. The data was rechecked and were
analyzed by using SPSS windows. The data were analyzed by using both descriptive and inferential
statistics.

 Organize the data

 Frequency and percentage distribution of the demographic variables.
 Data on menopausal symptoms levels among control and experimental group were analyzed
by t test.
 Association between groups score was analyzed using Pearson chi square
test.

 Difference between groups score was analyzed using student’s independent t-test.
 Difference between pretest and posttest score was analyzed using
Student’s paired-test.