| 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
|
|
|
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
|
|
|
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 |