From

Ms Kessiya Mariam Thomas

Ms Athira K

Ms Olivia Johnson

To

Chairperson IEC

Aster MIMS Calicut

Subject: Submission of proposal for IEC

Respected Madam,

As a part B.Sc. Nursing Program,3rd Year students of MIMS College of Nursing, we are interested in conducting

research, titled “A study to assess the knowledge, attitude and perception regarding preconception care among

primi mothers attending antenatal clinic of tertiary care hospitals at Calicut”

Here by Sending the research proposal along with duly filed ethical clearance application form. Kindly Consider this

for the IEC clearance.

Thanking You

Yours Sincerely

Kessiya Mariam Thomas

Athira. K

Olivia J
 Application Form for Initial Review

Malabar Institute of Medical Sciences

IEC Ref.No:

General Instructions : a) Fill all questions. Mark NA if not applicable. Bold your answers.

b) Attach additional sheets if required

SECTION A – BASIC INFORMATION

1. Administrative Details

(a) Name of Organization: MIMS college of nursing, Malappuram

(b) Name of Ethics Committee: IEC, Aster MIMS, Calicut

(c) Name of Principal Investigator: Ms Athira K

Ms Kessiya Mariam Thomas
Ms Olivia Johnson

(d) Department/Division: 3rd year Bsc.Nursing

(e) Date of submission: 25/09/23

(f) Type of review requested: Full committee review

(g) Title of the study: Assess the knowledge, attitude and perception regarding preconception care among primi

mothers

Acronym/short title,(if any):NA

(h) Protocol number (If any): ……NA………Version number: ................ NA……

(i) Details of Investigators:

 Name Designation and Department and Address for

Qualification Institution Communication

Principal Investigator

Ms..Athira K 3rd year Bsc Nursing Mims College of Mims College of

Ms Kessiya Mariam Nursing,Puthukode,Mal Nursing,Puthukode,M

Thomas appuram alappuram

Ms.Olivia Johnson

Co-investigator/ guide

Ms CHINCHU K Senior lecturer Department of Mims College of

foundation of Nursing. Nursing, Puthukode,

Mims College of Malappuram

Nursing, Puthukode,

Malappuram

(j) Number of studies where applicant is a :

(i) Prinicipal Investigator at time of submission:Three

(ii)Co- Investigator at time of submission:One

(k) Duration of the study :2weeks

2. Funding Details And Budget.

(a) Total estimated budget for site :

At site:5000/- In India: Globally:

(b) Self – funding Institutional funding Funding agency (specify)

SECTION B – RESEARCH RELATED INFORMATION

3. Overview of Research

(a) Lay summary (within 300 words):

The main purpose of the study is to assess the knowledge, attitude and perception regarding preconception care

among primi mothers attending tertiary care hospitals, Calicut, who meets the inclusion and exclusion criteria. The

sample consists of 50 primi mothers, selected using non probability convenient sampling technique. The research

approach is quantitative, descriptive research design. After obtaining informed consent the data will be collected using

the proposed tools. Data will be analysed using descriptive and inferential statistics.

(b) Type of study :

Basic Sciences Clinical Cross Sectional

Retrospective Epidemiological Case Control

Prospective Public Health Cohort

Qualitative Socio- behavioural Systematic Review

Quantitative Biological samples/ Date

Mixed Method Any others (specify)

4. Methodology

(a) Sample size/ number of participants (as applicable) :50

At site In India Globally

Control group Study group

Justification for the sample size chosen (100 words); In case of qualitative study, mention the criteria used for

saturation

(b) Is there an external laboratory/ outsourcing involved for investigation? Yes No

(c) How was the scientific quality of the study assessed?

Independent external review Review by sponsor/ Funder Review within PI's Institution

Review within multi-centre No review

Date of Review :28/09/23

Comments of scientific committee, if any (100 words) :

SECTION C: PARTICIPANT RELATED INFORMATION

5. Recruitment And Research Participants (a)

Type of participants in the study :
Health volunteers Patients Vulnerable persons/ Special groups

Others (specify): primi mothers

Who will do the recruitment? :Investigators

Participant recruitment method used: Posters/ leaflets/Letters TV/Radio ads/ social media/ Institution website

Patients/ Family / Friends visiting hospitals

Telephone Others (specify):Direct contact

 (b) i. Will there be vulnerable persons/ special groups involved ? Yes No NA

ii. If yes, type of vulnerable persons/ special groups

Children under 18 yrs Pregnant or lactating women

Differently abled (Mental/ Physical) Employee/ Students/ Nurses/ Staff

Elderly Institionalized

Economically and socially disadvantaged Reugees/ Migrants/ Homeless

Terminally ill (stigmatized or rare diseases)

Any other (Specify) :

iii. Provide justification for inclusion/exclusion :

INCLUSION CRITERIA:Primi mothers of age group 18-30years

Primi mothers who are able to read and write Malayalam

EXCLUSION CRITERIA:Primi mothers of age group below 18years and above 30 years

Primi mothers who are not willing to participate in this study Primi mothers

who do not know malayalam iv. Are there any additional safeguards to

protect research participants? :NO

(c) Is there any reimbursement to the participants? Yes, No NA

If yes, Monetary Non- monetary Provide details

(d) Are there any incentives to the participants? Yes, No NA

If yes, Monetary Non- monetary Provide details

(e) Are there any participant recruitment fee/ incentives for the study provided to the PI/ Institution ? Yes

No NA

If yes, Monetary Non- monetary Provide details

6. Benefits And Risks

(a). i. Are there any anticipated physical/ social/ psychological discomforts/ risk to participants?
 Yes No

If yes, categorize the level of risk:

Less than Minimal risk Minimal risk

Minor increase over minimal risk or low More than minimak risk or high risk

ii. Describe the risk management strategy :NA

(b) What are the potential benefits from the study? Yes No If yes direct Indirect For participant: The

primi mothers may understand regarding preconception care

And there by ensuring the fetal wellbeing.

For the society/ community-Study findings may help to reveal if there exist a positive or negative relationship

between knowledge, attitude and perception regarding preconception care and sociodemographic variable or

not .

For improvement in science: Study finding may help to scientifically identify level of knowledge, Attitude,

Perception regarding preconception care among primi mothers. Please describe how the benefits justify the

risks:

(c) Are adverse events expected in the study? Yes No NA

If Yes (specify):

7. Informed Consent

(a). Are you seeking waiver of consent? NO

If yes, please specify reasons and skip to item no.8

(b) Version number and date of Participant Information Sheet (PIS):

Version nuber and date of Informed Consent Form (ICF):

(c) Type of consent planned for:

Signed consent Verbal/Oral consent Witnessed consent

Audio- Video consent (AV) Consent from LAR (If so, specify from whom)
 For children<7 yrs parental/ LAR consent

Verbal assent from minor (7-12 yrs) along with parental consent

Written assent from minor (13-18 yrs) along with parental consent

Other (specify):

(d) Who will obtain the informed consent? Principal investigator

(e) Participant Information Sheet (PIS) and Informed Consent Form (ICF):

English Local Language Other (specify):

List the languages in which translations were done:

If translation has not been done, please justify:

(f) Elements contained in the Participant Information Sheet (PIS) and Informed Consent Form ICF)
Simple language Data/sample size Compensation for study related injury

Risks and discomforts Need to recontact Statement that consent is voluntary

Alternatives to participation Confidentiality Commercialization/Benefit sharing

Right to withdraw Study involves research benefits search storage of samples Benefits
Return of research results Use of photographs/ Identifying data

Purpose and procedure Payment for participation Contact information of PI and Member

Secretary of EC

Other (Specify):

8. Payment/ Compensation

(a) Who will bear the costs related to participation and procedures ?

PI Institution Sponsor Other agencies (specify):

(b) Is there a provision for free treatment of research related injuries? Yes No NA

If yes, then who will provide the treatment?

(c) Is there a provision for compensation of research related SAE? Yes No N/A
 If yes, specify.

Sponsor Institutional/Corpus fund Project grant Insurance

d) Is there any provision for medical treatment or management till the relatedness is determined for injury to the

participants during the study period? Yes No N/A

If yes, specify :

(e) Is there a provision for ancillary care for unrelated illness during the study period?

.Yes No N/A If yes, please specify

9. Storage And Confidentiality :

(a) Identifying Information: Study Involves samples/data. YES No N/A

If Yes, specify :

Anonymous/Unidentified Anonymized: Reversibly coded

Irreversibly coded Identifiable

If identifiers must be retained, what additional precautions will be taken to ensure that access is limited /data is

safeguarded? (e.g. data stored in a cabinet, password protected computer etc.) :

(b) Who will be maintaining the data pertaining to the study? :PI

(c) Where will the data be analyzed and by whom? :PI

(d) For how long will the data be stored? 6 months

(e) Do you propose to use stored samples/ data in future studies? Yes No Maybe

If yes, explain how you might use stored materila/data in the future ?
10. Publication, Benefit Sharing And IPR Issues :

(a) Will the results of the study be reported and disseminated? Yes No NA

If yes, specify.:

(b) Will you inform participants about the results of the study? YES, No NA

(c) Are there any arrangements for continued provision of the intervention for participants, if effective, once the

study has finished? If yes describe in brief (50 words) Yes No NA

(d) Is there any plan for post research benefit sharing with paricipants? Yes No NA

If yes, specify:

(e) Is there any commercial value or a plan to patent/ IPR issues? If yes, please provide details

Yes No NA

(f) Do you have any additional information to add in support of the application, which is not included

elsewhere in the form? Yes No NA

RESEARCH PROPOSAL

TITLE OF THE STUDY

A study to assess the knowledge attitude and perception regarding preconception care among primi mothers.

INTRODUCTION: Preconception care is any intervention provided to women and couples of childbearing age,

regardless of pregnancy status or desire, before pregnancy, to improve health outcomes for women, newborns and

children . It is an integral part of antenatal care because this care programme has potential to assist women by reducing

risk, promoting healthy lifestyle and improving readiness for pregnancy. As well as it is important to minimize fetal

malformation .There is growing evidence that preconception care may have an important role in preventing short and

long term adverse health consequences for women and their offspring every minute. Preconception health encompasses

a wide range of areas including women’s genetic risks, overall health status, reproductive history, exposure to

environmental toxins, and lifestyle. Moreover, risk factors such as pre -existing health conditions,exposure to dangerous

substances, and engagement in high-risk behaviors (e.g., substance use/abuse, excessive weight gain, etc.) may increase

the potential for adverse pregnancy and birth outcomes

Preconception care helps in addressing pre-pregnancy health risks and health problems that could have negative

maternal and fetal consequences. Therefore, it has potential to further reduce global maternal and mortality and

morbidity especially in low income countries where the highest burden of pregnancy

Rationale of conducting study

Preconception health encompasses a wide range of areas including women’s genetic risks, overall health status,

reproductive history, exposure to environmental toxins, and lifestyle. Moreover, risk factors such as pre -existing

health conditions, exposure to dangerous substances, and engagement in high-risk behaviours may increase the

potential for adverse pregnancy and birth outcomes. Preconception care helps in addressing pre-pregnancy health

risks and health problems that could have negative maternal and fetal consequences. Therefore, it has potential to

further reduce global maternal and mortality and morbidity especially in low-income countries where the highest

burden of pregnancy related deaths and disability occurs. Twelve percent of women smoke during pregnancy
contributing to fetal addiction to nicotine. Thirteen percent consume alcohol during pregnancy leading to fetal

alcohol spectrum disorder.

The benefit of preconception care is the improvement of public health which gain through the improvement of

individuals health. Preconception care focus only the physical preparation for pregnancy Parenting and also on the

social, psychological and spiritual elements.

Review of Literature

Review of literature is grouped under the following

1. Literature related to knowledge ,Attitude, Perception regarding preconception care

A cross sectional study was conducted to assess knowledge, Attitude and practice regarding

preconception care among 135 women attending rural clinic in Kelantan. A self-administered questionnaire was

administered to 135 respondents from 18 to 45 years of age. The questionnaire consisted of four domains,

assessing socio-demographic data and knowledge, attitudes and practice of preconception care. Results: The

mean (SD) knowledge, attitude and practice scores were 11.37 (3.94), 15.39 (2.12) and 10.13 (2.30),

respectively. In total, 98.5% of the respondents had good attitudes, 45.2% had good practices, and 51.9% had

good knowledge of preconception care

A descriptive cross-sectional study was conducted using a mixed methods approach to assess the

Knowledge and perceptions of preconception care among health workers and women of reproductive age in

Mzuzu City. A total of 253 women of reproductive age from nine townships of Mzuzu City responded to the

questionnaire and 20 health workers were interviewed.Results of the study shows that A total of 136 (54%)

respondents had heard of preconception care. About 57.7% (n = 146) demonstrated a good level of knowledge

of preconception care while 42.3% (n = 107) had poor knowledge

Objective

1. To Assess the knowledge regarding preconception care among primi mothers

2. To Assess the Attitude regarding preconception care among primi mothers

3. To Assess the Perception regarding preconception care among primi mothers

 4. Find out the relationship between knowledge and attitude regarding preconception care among primi

mothers.

5. Find out the relationship between knowledge and perception regarding preconception care among primi

mothers.

6. Find out the relationship between attitude and perception regarding preconception care among primi

mothers.

7. Find out the association of knowledge regarding preconception among primi mothers with selected

sociodemographic variables

8. Find out the association of attitude regarding preconception care among primi mothers with selected

sociodemographic variables

9. Find out the association of perception regarding preconception care among primi mothers with selected

socio-demographic variables Operational definition

1. Knowledge: In the present study knowledge refers to the level of awareness of preconception care.

2. Attitude: In the present study Attitude refers to the way of thinking or feelings of primi mothers regarding

preconception care.

3. Perception: In the present study perception refers to the ability of being aware or to notice and understand

regarding preconception care by primi mothers.

4. Preconception care:In the present study preconception care is defined as a set of interventions that aim to

identify and modify biomedical ,behavioural and social risks to the women’s health or pregnancy outcome

through prevention and management

5. Primi mothers:A women who has giving birth to one child or who is giving birth for the first time

Assumptions

• Primi mothers may have some knowledge about preconception care

• Primi mothers may have positive attitude towards Preconception care

 • Primi mothers may have good perception towards Preconception care

Hypothesis

H1: There will be significant relationship between knowledge and attitude regarding Preconception care among primi

mothers

H2: There will be significant relationship between knowledge and perception regarding Preconception care among

primi mothers

H3: There will be significant relationship between attitude and perception regarding Preconception care among primi

mothers

H4: There will be significant association of the knowledge of primi mothers regarding preconception care with

selected socio-demographic variable.

H5: There will be significant association of the attitude of primi mothers regarding preconception care with
sociodemographic variables.

H6: There will be significant association of the perception of primi mothers regarding preconception care with

selected socio-demographic variable.

INCLUSION CRITERIA

• Primi mothers of age group 18-30 yrs.

• Primi mothers who are willing to participate in this study.

• Primi mothers who are able to write and read.

EXCLUSION CRITERIA

• Primi mothers of age group below 18yrs and above 30yrs.

• Primi mothers who are not willing to participate in this study.

• Primi mothers who do not know Malayalam.

Materials and methods

• Research approach: Quantitative approach

 • Research design: Descriptive research design

• Setting: OPDs of tertiary care hospitals, Calicut.

• Sampling technique: Convenient sampling technique

• Sample size:50

TOOLS:

TOOL 1: Sociodemographic proforma

TOOL 2: Self structured Questionnaire to assess the knowledge regarding preconception care among primi mothers

TOOL 3: Five-point Likert scale to asses the attitude regarding preconception care among primi mothers

TOOL 4: Three-point Likert scale to assess the perception regarding preconception care among primi mothers

METHOD OF DATA COLLECTION: After obtaining IEC clearance, consent to conduct study will be taken

from opds of tertiary care hospital Calicut. Subjects will be selected using convenient sampling technique.

Contact details of the selected sample will be taken and data will be collected using checklist and questionnaire,

after seeking informed consent from each participant.

ETHICAL CONSIDERATIONS

1. Ethical clearance will be obtained from the Institutional Ethical Committee, Aster MIMS Hospital,

Calicut.

2. An informed written consent will be obtained from thestudy participants in their own language. 3.

Confidentiality and anonymity of the study participants will be maintained

Project timeline:

Week 1: Problem selection and IEC submission

4. Week 2: Data collection

 5. Week 3: Data analysis

6. Week 4: Project submission

7. Budget: 5000/-Participants will be given full autonomy to participate and withdraw from the study.

REFERENCES

1. Mtondera Munthali, Isabel Kazanga Chiumia, Chrispin Mandiwa & Saul Mwale Knowledge and perceptions of

preconception care among health workers and women of reproductive age in Mzuzu City, Malawi: a cross-sectional

study 18, Article number: 229 (2021)

2. Rosnani kasim,Nani draman,Azidah abdul kadir,Rosediani Muhamed owledge, Attitudes and Practice of

Preconception Care among Women Attending Appointments at a Rural Clinic in Kelantan DOI:10.5959/eimj.v8i4.475

TOOL 1 SOCIO DEMOGRAPHIC PERFORM

* Instructions:

Please read the questions carefully and put a tick mark in the appropriate (✓) bracket .

*Answer all the questions

*Give only one answer to each question.

Sociodemographic Performa:

1.Age in years

a) 18-21

b) 22-27

c) 28-35

1. Reliegion
 a) Hindu

b) Muslim

c) Christian

3.Educational status

a) Primary

b) High school

c) Higher secondary

d) Graduation and above

4.Occupation
a) Private employ

b) Government employ

c) Self-employed

d) Unemployed

5.monthly income

a) <Rs.15000

b) Rs.15000-Rs.30000

c) Rs.30001-RS.60000

d) Rs.60001-Rs.1,00,000

e) >Rs.1,00,000

6. Type of family
 a) Nuclear

b) Jointed

c) Extended

7. Marital status

a) Married b) Unmarried

8. Duration of marriage

a) <6 months

b) 6 months -1 year

c) 1-3 years d) >3 years

9Number of conceptions?

a) Nil

b) One c) More than one

TOOL 2

SELF STRUCTURE QUESTIONNAIRE TO ASSESS KNOWLEDGE REGARDING PRECONCEPTION

CARE

1,Risk of high risk pregnancy is

a) Age below 18 years

b) Small body size

c) First pregnancy at age 35years and above

2, Recommendation for good birth spacing practices

a)one year?

b) between 2 to 4year

c) more than 5 year

3) Knowledge of diet during pregnancy?

a) Eat a balanced diet but more frequently than more non pregnant women

b)Eat a diet with higher iron content

c)Eat diet with higher calcium content

d) Eat less fat

4) Risk of maternal anemia for baby?

a) Low birth weight

b) Pale

c)Good appetite

d)Increase Blood pressure

5) What is preconception care?

a)The care the couple needed to take during pregnancy

b)The care the couple needed to take before pregnancy

c)The care couple neede to take After delivery

d) The care couple needed to take before conceiving 6)

Why does preconception care more important?

a)Major development occurs in first 2-8 weeks

b) Major development occur In 12-18 weeks

c) Major development occur in after 18 weeks 7)

What is the duration of preconception period?

a) 3months to one year before conception

b)6months before conception

c)5year before conception

8) What is the minimum duration recommended in between each pregnancy? a)

1year

b) between 2-4 year

c) 5year

9) What is the risk of untreated hypothyroidism in women?

a) Gastric complaints

b) Infertility

c) Nerve problems

10) Have you take vaccination against measles and rubella like infection.if yes,what is the minimum time that the

women has to wait for conception after receiving the vaccination? a)1month
b) 2month

c)3month

11) Which element has to be taken during preconception period to prevent neural tube defect in newborn? a)

Folic acid

b) Vitamin A

C)Zinc

12) How the intake of omega 3 fatty acid benefit newborn?

a) Formation of new cells

b) Improve digestion

c) Easy movement

13) What is the recommended dose of fatty acid during preconception period? a)

4mg daily

b) 2mg daily

c) 1mg daily

14) What do you mean by obesity?

a) BMI of less than 19.9

b) BMI of 30 and above

c) BMI of 25.9

15) Why an under weight women should gain weight before conception?

a) To prevent low birth weight

b)Have lower weight babies

c)To prevent infection

16) Which of the following is a best practice for women with chromic medical illness such as Diabetes mellitus

,Hypertension and thyroid problem?

a) attend medical checkup for planning

b)Planning to not get pregnant

c)Receive advice from friends and family

17) Which of the following is a rich source of folic acid?

a) Milk and milk products

b)Green leafy vegetables

c)Liver

18) Which complication may occur in fetus due to gestational diabetes?

a) Congenital malformation

b) Low birth weight

c)Anemia

19) Which of the following metal is higher exposure during pregnancy can lead to malformation

like mental retardation and still birth?

a)Copper

b)Mercury

c)Lead
20) What adverse effect result due to maternal smoking before pregnancy? a)Low birth weight

b)Sudden infant death syndrome

c)Congenital cardiovascular disease

21) Which aong the following is the best treatment measure for women with chronic diabetes mellitus during

preconception care?

a) Adding protein rich food in diet

b) Oral hypoglycemic agent

c) Insukin therapy

22) What is the appropriate duration for supplementing folic acid for achieving a healthy fetal outcome?

a)4 weeks prior to conceptiob upto 12weeks of pregnancy

b) 3months prior to conception

c) 6months prior to conception

23) Which system of the baby will be severely affected due to increased intake of animal livr and liver products by

women before pregnancy?

a) Respiratory system

b) Gatrointestinal system

c) Cardiovascular system

24) Which among the following is the best source of zinc?

a)Vegetables

b) Meat
c) Oyster

25) How the intakes of omega 3 fatty acid benefit newborn?

a)Formation of new cells

b) Improve digestion

c) Easy movement

ANSWER KEY

1.C 2.B 3.A 4.A 5.B 6.A 7.A 8.B 9.B 10.A
11.A 12.A 13.A 14.B 15.A 16.A 17.B 18.A 19.C 20.B
21.C 22.A 23.C 24.B 25.A
 TOOL- 3 FIVE POINT LIKERT SCALE TO ASSESS THE ATTITUDE REGARDING PRECONCEPTION

CARE AMONG PRIMI MOTHERS

QUESTIONS STRONGLY AGREE NEITHER DISAGREE STRONGLY

AGREE AGREE DISAGREE

NOR

DISAGREE

1.preconception care provide the

most incredible opportunity to
optimize couple’s health particularly
women’s health before conception

2. Providing preconception care

services is considered as luxury
services .

3 .The focus of preconception care

should not be directed to healthy
people but to people with infectious
disease.

4. Preconception health is part of

the reproductive condition.

5. Preconception health is part of

the reproductive condition.

6. All health care providers can

easily integrate the elements of
preconception care in their daily
practice to all eligible individuals.

7. The process of other competing

demands providing preconception
care is not priority intervention
among health workers.

8.Omission of preconception care

leads to an irreversible damage to
fetus.
TOOL-4 Three point likert scale to Assess perception regarding preconception care

among primi mothers

SL QUESTIONS NEITHER
AGREE NOR
NO. AGREE DISAGREE DISAGREE

1. Exercising regularly is
necessary in preconception
care

2. Smoking or tobacco
consumption of your partner
affects the fetus life

3. Recommended dose of folic

acid intake is a part of

preconception care.

4. Immunization against tetanus

and rubella is necessary before
conception.

5. Habit of taking over the

counter medications is harmful

6. Taking measures to maintain

menstrual hygiene is a part of
preconception care

7. An underweight women should

 gain weight before conception.

8. A balanced diet should be

consumed during preconception
period.

9. Mental health of a women

affect the health of fetus

10. Taking proper treatment for

conditions such as diabetic
mellitus ,hypertension and
thyroid disorders is necessary
 PARTICIPANT INFORMATION SHEET

Title of the study: Assess knowledge,Attitude and perception regarding preconception care among

primi mothers.

Sponsor name: Nil

Language: Malayalam

Principal investigator: Ms Athira K

Ms Kessiya Mariam Thomas

Ms Olivia
JohnsonMs.Athira.K
Designation: 3rd year B.Sc Nursing

Institution: MIMS college of nursing

Please read this form carefully. If you do not understand the language or any infor- mation in the document,

please discuss it with the study investigator. Your participation in this study is voluntary, and you can

enquire about all details before giving your written consent to participate in this study.

1. INTRODUCTION

You are invited to participate in this study as it is aiming at assessing knowledge,Attitude,Perception

regarding preconception care among primi mothers.

 2. Purpose of the study

Purpose of the study is to Assess knowledge,Attitude and perception regarding preconception care among

primi mothers

Who can take part?

INCLUSION CRITERIA

• Primi mothers of age group 18-30 yrs.

• Primi mothers who are willing to participate in this study.

• Primi mothers who are able to write and read.

EXCLUSION CRITERIA

• Primi mothers of age group below 18yrs and above 30yrs.

• Primi mothers who are not willing to participate in this study.

• Primi mothers who do not know Malayalam.

4. Information about the study

● Total no of participants:50
 ● Duration of study:2 weak

5. What will happen in the study

• Basic information will be collected using socio-demographic datasheets.

• Mothers will be given the tool for assessing the knowledge,attitude,perception regarding
preconception care among primi mothers. Confidentiality will be maintained.
6. Your role/responsibility in the study

● Provide accurate information whenever asked

● Inform the study investigators about any problem experienced during the study

● Follow the investigators instructions

● If you want to discontinue from the study, study investigators to be informed

7. What all are the risk: nil

8. Cost of participating in the study: nil

9. Compensation for injury: nil

10. Confidentiality of information

Information from the study records including your name, address, result of test, study results

will be kept confidential and will be reviewed only by authorized personnel from the sponsor or

their representative, and ethics committee or regulatory bodies. The data will not be made available

to another individual unless you specifically give permission in writing. Information and results

from the study may be presented at meetings or published including your name and personal

identifications. No reference will be made in oral or written reports, which could link you to the

study.
12. New information about the study
Any new information available during the course of study will be informed to you if it has

relevance to your decision regarding continuing in the study. Results of your participation will be

disclosed to you if you indicate your desire for it.

13. Voluntary participation

Your participation in the study is voluntary, you can decline to participate at any time and you

need not give any reason for the same and such withdrawal shall be without penalty and without

loss of benefits to which you are otherwise untitled. If you withdraw from the study before data

collection is completed, your data collected until you indicated withdrawal would be used in the

study report. This investigator may stop the research or your participation in it at any time for some

or other reason without permission.

14. Whom to contact in case of any questions

If you experience adverse effects because of participating in the study, you may contact the

principal investigators as detailed above. If you have any questions about this form or any study

related issues, you may also contact the following person

Principal Investigator: Ms Athira K

Ms Kessiya Mariam Thomas

Ms Olivia Johnson

Address : 3rd Year BSc Nursing

MIMS College of nursing, Puthukod
 INFORMED CONSENT FORM

Project title: ASSESS KNOWLEDGE,ATTITUDE AND PERCEPTION REGARDING

PRECONCEPTION CARE AMONG PRIMI MOTHERS

I confirm I have read the Participant Information Sheet for the above study and its contents were explained

and I have had the opportunity to ask questions and received satisfactory answers

I understand that my participation in the study is voluntary and that I have the right to withdraw at anytime

without giving any reason, without my medical care or legal rights being affected.

I agree to take part in the above study. I confirm that I have received a copy of the Participant Information

Sheet along with this signed and dated informed consent form.

Name of the Research Participant:

Age of the Research Participant:

Address of the Research Participant:

Signature of the research subject Date

Name & Signature of the witness Date

Name & Signature of the person explaining the consent Date.