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CTRI Number  CTRI/2025/07/092114 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Mothers Knowledge on Swaddling Techniques for Newborns 
Scientific Title of Study   Assess the effectiveness of Video assisted learning on knowledge regarding swaddling techniques among Mothers of newborn. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Switi A Besekar 
Designation  Post graduate student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of child health nursing, Ground floor, SRMMCON Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  8625058572  
Fax    
Email  switir21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Darshana Wankhede 
Designation  Assistant professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of child health nursing, Ground floor, SRMMCON Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  8421960453  
Fax    
Email  kumaridiya90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Darshana Wankhede 
Designation  Assistant professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of child health nursing, Ground floor, SRMMCON Building, Sawangi Meghe


MAHARASHTRA
442001
India 
Phone  8421960453  
Fax    
Email  kumaridiya90@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi Meghe Wardha, India 442001 
Type of Sponsor  Private medical college 
 
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 
Switi Besekar  Acharya Vinoba Bhave Rural Hospital  Department of Child Health Nursing, 2nd floor, Acharya Vinoba Bhave Rural Hospital Building , Sawangi Meghe
Wardha
MAHARASHTRA 
8625058572

switir21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Datta Meghe Institute Of Higher Education And Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Video assisted learning regarding swaddling techniques among Mothers of newborn  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Video Assisted learning on knowledge regarding swaddling techniques among Mothers of newborn  Mothers of newborn will be given video assisted learning on knowledge regarding swaddling technique for 6 months. Pre and Post score of knowledge will be compared at 6 months 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Primigravida and Multigravida Mother
2.Those who are available at time of time data collection.
3.Those who could read write & understand Marathi.
 
 
ExclusionCriteria 
Details  1.Mother who is health professional
2.Those who attended any program on similar topic
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase knowledge regarding swaddling techniques  Assessment will be done at 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/09/2025 
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 Yet Recruiting 
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  

Abstract

Introduction:
The birth of a newborn is a significant and emotional event. Proper newborn care is crucial for healthy physical and mental development. Infant sleep is a dynamic process essential for growth and is often disrupted by irregular sleep patterns. Swaddling, an ancient technique of wrapping infants snugly in blankets, has been shown to calm babies, reduce crying, and promote longer sleep durations by mimicking the womb environment.

Background:
Swaddling is widely used in neonatal care, especially for preterm infants, to reduce stress and improve sleep and physiological stability. Research suggests it supports self-regulation, reduces pain responses, and improves neuromuscular development. Despite its benefits, safe swaddling techniques must be followed to avoid risks such as hip dysplasia and sudden infant death syndrome (SIDS).

Objectives:
This study aimed to assess pre-test knowledge of swaddling techniques among mothers of newborns, evaluate the effectiveness of video-assisted teaching on their knowledge, and explore associations with demographic variables.

Methodology:
A quantitative, one-group pre-test and post-test design was employed among 120 mothers of newborns in a selected hospital in Nagpur using convenient sampling. Data were collected using a validated knowledge questionnaire and analyzed through descriptive and inferential statistics.

Results:
The study found a significant improvement in mothers’ knowledge scores regarding swaddling techniques following the video-assisted teaching intervention (p<0.05). Demographic factors such as education and parity showed associations with knowledge levels.

Conclusion:
Video-assisted teaching is an effective method to enhance mothers’ knowledge on safe swaddling techniques, which can improve newborn care practices and promote better infant sleep and wellbeing.

Keywords:
Swaddling, Newborn Care, Infant Sleep, Video-Assisted Teaching, Maternal Knowledge, Neonatal Health

 
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