| CTRI Number |
CTRI/2025/04/086001 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Progressive Muscle Relaxation technique] |
| Study Design |
Other |
|
Public Title of Study
|
The Efficacy of Progressive Muscle Relaxation in Promoting Healthy Pregnancy Outcomes, Reducing Pregnancy-Related Stress, and Enhancing Sleep Quality. |
|
Scientific Title of Study
|
Impact of progressive muscle relaxation technique on outcome of pregnancy, reduction of stress and quality of sleep among primigravida mothers in selected maternity hospital Bangalore |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
J Vijayalakshmi |
| Designation |
PhD Scholar |
| Affiliation |
R.R College of Nursing |
| Address |
Department of OBG Nursing, Room No. 8, First floor, Nursing Block, R.R college of Nursing, Raja Reddy Layout, Near Chikkabanavara railway station, Hesaragatta road, Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
6360707138 |
| Fax |
|
| Email |
vedanthviji2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya |
| Designation |
Professor |
| Affiliation |
R.R College of Nursing |
| Address |
HOD, Department of OBG Nursing, Room No. 8, First floor, Nursing Block, R.R college of Nursing, Raja Reddy Layout, Near Chikkabanavara railway station, Hesaragatta road, Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9980522399 |
| Fax |
|
| Email |
sukanya63@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
J Vijayalakshmi |
| Designation |
PhD Scholar |
| Affiliation |
R.R College of Nursing |
| Address |
Department of OBG Nursing, Room No. 8, First floor, Nursing Block, R.R college of Nursing, Raja Reddy Layout, Near Chikkabanavara railway station, Hesaragatta road, Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
6360707138 |
| Fax |
|
| Email |
vedanthviji2020@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
J Vijayalakshmi |
| Address |
R.R college of Nursing, Raja Reddy Layout, Near Chikkabanavara railway station, Hesaragatta road, Bangalore-560090 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DrAnand CHO |
Hosahalli Referral Hospital |
BBMP, 1st floor, 6H9, 8th Cross, 1st Main road, Govindaraja Nagar ward, Govindaraja Nagar, MC Layout, Vijayanagar, Bengaluru-560040
Bangalore
KARNATAKA |
9480683910
vasanthviji2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RR College of Nursing |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primigravida mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Progressive Muscle Relaxation Technique |
Intervention with routine care Progressive muscle relaxation technique including Video assisted demonstration by the researcher on day 1 and enaction by the participant for 2 days and subsequent visits, as well as self practice once in a day for 20 to 30 minutes till delivery |
| Comparator Agent |
Routine care |
No intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida mothers who are at Low risk and attending regular antenatal clinic
between 24 and 26 weeks of gestation willing to participate in the study
Planning to have intranatal and post-natal care in the follow-up setting
With minimal to moderate level of stress
Able to understand English and kannada
|
|
| ExclusionCriteria |
| Details |
Primigravida mothers who are having severe muscule and skeletal disorders
Practicing any other relaxation method routinely
With hearing or visual impairment
With a bad obstetrical history
With severe psychological disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maternal and fetal outcome of Pregnancy |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of stress and Quality of sleep |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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)
|
12/05/2025 |
| 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="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
|
This study is a randomized controlled trial to assess the impact of progressive muscle relaxation technique on the outcome of pregnancy, reduction of stress, and quality of sleep among primigravida mothers in selected maternity hospitals in Bangalore. A simple random sampling technique was adopted to assign samples in both experimental and control groups. Hypotheses H1: There will be a significant difference between pretest and posttest levels of scores among primigravida mothers in experimental group receiving progressive muscle relaxation technique and the control group. H2: There will be a significant association between outcome of pregnancy, stress and quality of sleep among primigravida mothers with selected demographic variables in experimental and control group. |