| CTRI Number |
CTRI/2025/08/093862 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to see how a sleep improvement program helps pregnant women sleep better during their regular check-ups |
|
Scientific Title of Study
|
Effect of sleep health behaviour intervention on sleep quality among antenatal mothers attending Antenatal OPD in AIIMS Bhubaneswar |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gomathi B |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
First floor, College of Nursing AIIMS Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9675370182 |
| Fax |
|
| Email |
con_gomathi@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gomathi B |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
First floor, College of Nursing AIIMS Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9675370182 |
| Fax |
|
| Email |
con_gomathi@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Mahato |
| Designation |
M.Sc Nursing 1st year |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No-02, Ground floor, PG-1B, AIIMS Residential Complex, Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
6291479250 |
| Fax |
|
| Email |
mahato.manisha01@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
AIIMS BHUBANESWAR |
| Address |
SIJUA, BHUBANESWAR,KHURDHA ODISHA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Gomathi B |
AIIMS Bhubaneswar |
Obstetrics , Gynecology and Neonatology Ward F-2, Sijua, Patrapada, 751019
Khordha
ORISSA |
09675370182
con_gomathi@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Antenatal mothers attending antenatal OPD in AIIMS Bhubaneswar |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
Antenatal care as per hospital policy |
| Intervention |
Sleep health behavior intervention |
Potential participants in between gestational age of 20 -32 weeks are identified in
gynecology OPD during their antenatal check up and selected by convenient
sampling method by collaborating with healthcare providers (gynecologists ,nurses )
to refer mothers who are meeting the inclusion criteria . Eligible participants are provided detailed information about the study including
objectives of the study ,expected duration of participation ,nature of
intervention ,potential risks and benefits Written informed consent is taken from the participants for willingness to part in the
study Random allocation of participants in intervention group ( sleep health behavior
intervention and Routine care) and control group ( routine care ) is achieved by using
SNOSE method
After allocation of participants ,sociodemographic data of mothers are collected using
sociodemographic proforma and baseline data on sleep quality is taken from both
intervention and control group is taken using Pittsburgh sleep quality index (PSQI ) On the same day intervention group only given sleep health behavior education on
sleep hygiene practice and demonstrated relaxation technique ( breathing exercise , progressive muscle relaxation ) and one video on the demonstrated exercise and
checklist will be provided to them. One whatsApp group will be formed with the intervention group and researcher
including experts also to guide mothers .For adherence purpose , adherent checklist will be provided .Intervention group mothers will be called weekly with their adherent checklist and
checklist will be checked for all components of education
Intervention group and control group mothers will be called 4 week after the
intervention and sleep quality tool will be administered |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant woman of gestational age between 20 to 32 weeks at the time of enrolment
Pregnant mother who are willing to participate
Pregnant women who are able to understand odia language
Pregnant women who are using smart phone |
|
| ExclusionCriteria |
| Details |
History of psychiatric illness( Bipolar disorder , severe depression)
Antenatal mothers with diagnosed sleep disorders requiring medical treatment
More than 2 nightshift per week during the study period |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality |
At baseline and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="2"
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
|
The study aims to assess the effect of sleep health behavior intervention on sleep quality among antenatal mothers attending antenatal OPD in AIIMS Bhubaneswar. A randomized controlled trial design will be used . Mothers will receive the training and perform the intervention at home . Sleep quality of antenatal mothers will be assessed at baseline and after 4 weeks interval to determine the effectiveness of the intervention |