| CTRI Number |
CTRI/2025/05/086947 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
motherhood experience, household work and Quality of sleep in postnatal women |
|
Scientific Title of Study
|
Association Among Motherhood Experience Household Work Quality Of Sleep In Postnatal Women . |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GUNALSRI R |
| Designation |
Student |
| Affiliation |
SRM Institute of Science and Technology kattankulathur |
| Address |
Room no-PT 13 5th floor SRM College of Physiotherapy SRM Institute of Science and Technology Kattankulathur Chengalpattu Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6382996930 |
| Fax |
|
| Email |
srigunal2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T S SUBICHA |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology,Kattankulathur |
| Address |
Room no -PT 14 Experts paradise 5th floor SRM College of Physiotherapy SRM Institute of Science and Technology Kattankulathur Chengalpattu Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7200337170 |
| Fax |
|
| Email |
subichat@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
T S SUBICHA |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology,Kattankulathur |
| Address |
Room no -PT 14 Experts paradise 5th floor SRM College of Physiotherapy SRM Institute of Science and Technology Kattankulathur Chengalpattu Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7200337170 |
| Fax |
|
| Email |
subichat@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRMIST, Kattankulathur, Tamil Nadu,India 603203 |
|
|
Primary Sponsor
|
| Name |
GUNALSRI R |
| Address |
Room no - PT 13,5th floor, SRM college of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, chengalpattu ,603203 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| GUNALSRI R |
SRM Medical college amd Hospital, kattankulathur |
Room no-PT 13 5th floor SRM College of Physiotherapy SRM Institute of Science and Technology Kattankulathur Chengalpattu Tamil Nadu
Kancheepuram
TAMIL NADU |
06382996930
srigunal2004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postnatal mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
43.00 Year(s) |
| Gender |
Female |
| Details |
20 - 43 years who gave their consent for the study are included, Postnatal mothers are included, women at their 6th month postnatally, Singleton Birth |
|
| ExclusionCriteria |
| Details |
Women above 43 years, Multiple childbirth and having history of sleep disorders or Psychiatric illness and who are taking medications that affect sleep quality and experiencing during pregnancy are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the relationship between motherhood experience, household workload, and the quality of sleep among postnatal women within the first six months postpartum. |
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Examine the relationship between household work and motherhood experience in postnatal women. |
single time point |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2025 |
| 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="0"
Months="6"
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
|
This cross - sectional study aims to explore the association among motherhood experience ,household work and quality of sleep in postnatal women .The study will be conducted at the vaccination center, SRM Medical college and Research Centre ,Kattankulathur. Postnatal women attending the center within six months postpartum will be selected using purposive sampling. Data will be collected using a structured questionnaire ( Experience Of Motherhood to assess motherhood experience , IPAQ- International Physical activity questionnaire to assess the household work , SQS-Sleep Quality Scale to assess the quality of sleep ). Informed Consent for their Data collection will be obtained before the Assessing the mothers. Finally, the results will be analyzed with the assistance of a statistician. |