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CTRI Number  CTRI/2024/08/072882 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Fetus targeted maternal activities ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of fetus targeted maternal activities on feto-maternal attachment among pregnant women 
Scientific Title of Study   Effect of fetus targeted maternal activities on feto-maternal attachment among pregnant women in selected tertiary care hospital of Bhopal – A randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya kumari 
Designation  M.Sc. Nursing (Obstetrics and gynecology nursing) 
Affiliation  All India institute of medical sciences, Bhopal 
Address  Nursing college AIIMS Bhopal Saket Nagar, Bhopal, Madhya Pradesh, India

Bhopal
MADHYA PRADESH
462020
India 
Phone  9785617430  
Fax  9785617430  
Email  priyak.mscnursing23@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lily Podder 
Designation  Associate Professor, (Obstetrics and gynecology department) Nursing college 
Affiliation  All India institute of medical sciences, Bhopal 
Address  Nursing college AIIMS Bhopal Saket Nagar, Bhopal, Madhya Pradesh, India

Bhopal
MADHYA PRADESH
462020
India 
Phone  9970709068  
Fax  9970709068  
Email  assocprof.nursing@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Lily Podder 
Designation  Associate Professor, (Obstetrics and gynecology department) Nursing college 
Affiliation  All India institute of medical sciences, Bhopal 
Address  Nursing college, AIIMS Bhopal Saket Nagar, Bhopal, Madhya Pradesh, India

Bhopal
MADHYA PRADESH
462020
India 
Phone  9970709068  
Fax  9970709068  
Email  assocprof.nursing@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
All India Institute of medical sciences, Bhopal, Madhya Pradesh Pin code: 462020 India 
 
Primary Sponsor  
Name  Priya kumari 
Address  Nursing college AIIMS Bhopal Saket Nagar, Bhopal, Madhya Pradesh, India Pin code: 462020 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lily Podder  All India Institute of Medical sciences, Bhopal  Room no. 31, Antenatal OPD, AIIMS Bhopal
Bhopal
MADHYA PRADESH 
9970709068

assocprof.nursing@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee- Student Research (IHEC-SR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pregnant women  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL GROUP  Will receive routine care according to hospital policy 
Intervention  Fetus targeted maternal activities  Fetus targeted maternal activities: It is structured interventions designed by the researcher midwife which involve the following activities: 1. Maternal touch to sense the fetal movements in the womb by touching the abdomen (at three areas that is Upper abdomen (10 minutes), Left and Right lateral side (10 minutes), Lower abdomen (10 minutes)) for 30 minutes a day. 2. Positive affirmations sentences focusing on the fetal well-being and positive health outcome after the delivery. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  59.00 Year(s)
Gender  Female 
Details  Include Primigravida women who is:
Willing to participate
above the age of 18 years
below the age of 60 years
available at the time of data collection.
at, or crossed 28 weeks gestation with normal course of pregnancy.
possessing a smart phone
 
 
ExclusionCriteria 
Details  Include Pregnant women who:
Has medical & surgical complication which might complicate the pregnancy.
Is diagnosed with any psychological disorder.
Have crossed 32 weeks+6 days of gestation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feto-maternal attachment  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title of the study: “Effect of fetus targeted maternal activities on feto-maternal attachment among pregnant women in selected tertiary care hospital of Bhopal – A randomized Controlled Trial”.

Background of the study:

 The maternal-fetal attachment is the emotional bond that develops between a pregnant woman and her developing foetus. It involves feelings of affection, connection, and concern for the wellbeing of the developing foetus, fostering a strong maternal connection even before birth. (Wulff V 2021 et. al.)(1)

 Low maternal-foetal attachment, can contribute to various problems. It may impact the emotional and psychological well-being of both the mother and the developing foetus. Issues such as stress, anxiety, and depression can arise, potentially affecting prenatal care, birth outcomes, and the overall health of the child. (Glover V 2017 et.al.)(2)

The development of maternal–fetal attachment greatly affects the postnatal child-care environment and child development. It may influence mother–infant attachment after delivery and the maternal ability to care for the infant. (Glover V 2017 et.al.)(2)

NEED AND PURPOSE:

 In India, in which the mortality rate for women is 97 per 100,000 live births and the neonatal mortality rate is 20 deaths per 1,000 live births. (WH0,2020)

 Feto-maternal attachment is vital for the emotional, psychological, and physical wellbeing of both the mother and the fetus. It sets the foundation for a positive pregnancy experience and can contribute to healthier outcomes for both during pregnancy and after childbirth. ( Nishikawa M 2013 et. al.)(4)

 Healthy feto-maternal attachment may serve to allow women to adopt optimal health practices earlier, thereby on a larger scale contribute toward reduction of obstetric maternal and child morbidity and mortality.

In response to that strong evidence base for feto-maternal attachment there is need to took that study.

Objectives of the study:

1.To assess the feto-maternal attachment among pregnant women.

 2.To determine the effect of fetus targeted maternal activities on feto-maternal attachment among pregnant women.

3.To find out the association between feto-maternal attachment and selected socio demographic variables among pregnant women.

HYPOTHESIS:

H01: There is no significant difference in feto-maternal attachment at 0.05 level of significance.

H02: There is no significant association between feto-maternal attachment and selected socio demographic variables at 0.05 level of significance.

OPERNATIONAL DEFINITIONS:

 Effect: In Present study it refers to the extent to which fetus targeted maternal activities has an impact on the feto-maternal attachment among pregnant women will be assessed by structured tools and records.

 Fetus targeted maternal activities: It is structured interventions designed by the researcher midwife which involve the following activities:

 1. Maternal touch to sense the fetal movements in the womb by touching the abdomen (at three areas that is Upper abdomen (10 minutes), Left and Right lateral side (10 minutes), Lower abdomen (10 minutes)) for 30 minutes a day.

2. Positive affirmations sentences focusing on the fetal well-being and positive health outcome after the delivery.

Feto-maternal attachment: In present study it refers to the emotional bond that develops between a pregnant woman and her developing fetus. It involves feelings of affection, connection, and concern for the wellbeing of the developing fetus, fostering a strong maternal connection even before birth. It will be measured by the Standardized scale (Maternal antenatal attachment scale)

Pregnant women: In the present study, it refers to primigravida women who has crossed or is at 28 weeks of gestation but less than 33 weeks of gestation.

Material and methods:

Research Approach: Quantitative, true experimental.

Research design: Prospective Randomized Control Trial.

Research Variables:

Independent Variable: Fetus targeted maternal activities.

Dependent Variable: Feto-maternal attachment.

Research setting: Antenatal OPD of selected tertiary care hospital in Central India, AIIMS Bhopal.

POPULATION:

â–ªTarget population: Pregnant women who has crossed or is at 28 weeks of gestation but less than 33 weeks of gestation visiting Antenatal OPD.

â–ª Accessible population: Pregnant women who has crossed or is at 28 weeks of gestation but is less than 33 weeks of gestation visiting Antenatal OPD of selected tertiary care hospital in Bhopal.

â–ª Sample Population: Pregnant women who has crossed or is at 28 weeks of gestation but is less than 33 weeks of gestation vising Antenatal OPD of selected tertiary care hospital in Bhopal and present at the time of data collection.

• SAMPLE

☐ INCLUSION CRITERIA

Include Primigravida women who is:

â–ªWilling to participate

â–ªabove the age of 18 years

â–ªavailable at the time of data collection.

â–ªat, or crossed 28 weeks gestation with normal course of pregnancy.

â–ªpossessing a smart phone

☐ EXCLUSION CRITERIA

Include Pregnant women who:

â–ªHas medical & surgical complication which might complicate the pregnancy.

â–ªIs diagnosed with any psychological disorder.

â–ªHave crossed 32 weeks+6 days of gestation.

DESCRIPTION OF TOOL

 It consists of 2 sections:

ʉۢ Section 1:

o Part A - Demographic variable Performa

 o Part B - Clinical variable Performa

• Section 2: Maternal antenatal attachment scale (Standardized tool and available in Open Domain).

 Creator Condon, John T. (2015)

Description: The Maternal Antenatal Attachment Scale (MAAS) is a 19 item self-report questionnaire for the assessment of mother-to-infant attachment during the antenatal period.

The MAAS is used to assess the quality of the mother-fetus relationship in terms of overt (i.e., conscious) thoughts, feelings, attitudes and behaviors of the mother towards the fetus.

DESCRIPTION OF INTERVENTION PROTOCOL

Name of Intervention Protocol: structured intervention designed by the researcher midwife.

Intervention will include:

Total time period for the intervention: 21 days

Total duration of intervention is 30 mins.

Frequency of the intervention: Once (After food and Before bed).

Instructions:

v Before starting the intervention find a comfortable position to perform (sit with back support on chair, couch, or bed)

v Take a deep Breath.

v Relax your body – close your eyes if you are comfortable doing so or you can keep your eyes open, place your both hand on your abdomen.

Step 1. For first 10 mins put your both hands on the upper part of abdomen and feel for fetal movements and speak 5 following positive affirmation sentences to the fetus:

       i.          I am dedicated and loving mother.

     ii.           I love my baby unconditionally.

   iii.          I will have a strong and healthy baby.

   iv.           I love my baby and my baby loves me

     v.          My baby is safe and secure.

 

Step 2. For second 10 mins put your both hands on the Right and left lateral sides of abdomen and feel the fetal movements and speak 5 following positive affirmation sentences to the fetus:

         i.          My baby is growing strong and healthy.

       ii.          I will make the right decisions for my baby.

     iii.          I know how to take care of my baby.

     iv.          I will breast feed my baby.

       v.           I eat nourishing healthy foods so help my baby grow.

 

Step 3. For the last 10 mins put your both hands on the lower part of your abdomen and feel the fetal movements and speak following 5 positive affirmation sentences to the fetus:

          i.          I am accepting my pregnancy experiences.

        ii.           My baby will be born healthy and at the perfect time.

      iii.           My baby will be born without any complications.

       iv.           I am capable of delivering this baby.

         v.           I welcome my baby with love and happiness.

 SUMMARY

Feto-maternal attachment is an imperceptible connection and maintain a bond between mother and baby in her womb which is considered as an important part of fetal development and this attachment can be affected by different factors.

Fetus targeted maternal activities has an important role in developing this feto-maternal attachment.

This study intends to find the effect of fetus targeted maternal activities on feto-maternal attachment, in order to improve the Maternal-fetal attachment.

 
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