| CTRI Number |
CTRI/2020/06/025984 [Registered on: 19/06/2020] Trial Registered Prospectively |
| Last Modified On: |
04/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Intervention of Progressive muscle relaxation technique ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness of progressive muscle relaxation technique among the pregnant mothers above 32 weeks of pregnancy on reactivity and time consumption of non stress test attending Obstetrics and Gynaecology OPD, PGIMER Chandigarh 2019-2021 |
|
Scientific Title of Study
|
A randomised control trial to assess the effectiveness of progressive muscle relaxation technique among the antenatal mothers above 32 weeks of gestation on reactivity and time consumption of non stress test attending Obstetrics and Gynaecology OPD, PGIMER Chandigarh 2019-2021 |
| Trial Acronym |
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|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
L NGAHNEILAM |
| Designation |
MSc Nursing |
| Affiliation |
National Institute of Nursing Education PGIMER Chandigarh |
| Address |
National Institute of Nursing Education, 1st Floor , MSc Nursing students room no. 206 , PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09911726530 |
| Fax |
|
| Email |
neilam.lenthang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSukhjit Kaur |
| Designation |
Tutor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Dept. of Obstetrics and Gynaecology Nursing ,National Institute of Nursing Education, Ground floor , Room no.134 PGIMER ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09914536469 |
| Fax |
|
| Email |
Dr.sukhjitkaur13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
L Ngahneilam |
| Designation |
Msc Nursing Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, 1st Floor , MSc Nursing students room no. 206 , PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09911726530 |
| Fax |
|
| Email |
neilam.lenthang@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education, PGIMER , chandigarh |
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education Chandigarh |
| Address |
National Institute of Nursing Education, Post Graduate Institute of Medical and Research ,Sector 12 Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| L Ngahneilam |
Post Graduate Institute of Medical Education and Research |
Antenatal OPD , 2nd floor, C Block ,Room no. 2034, Dept. of Obstetrics and Gynaecology, New OPD building
Chandigarh
CHANDIGARH |
09911726530
neilam.lenthang@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee(Intramural) PGIMER |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Progressive Muscle Relaxation Technique |
1.The antenatal Mothers above 32 weeks of gestations are taught of progressive muscle relaxation exercise prior to undergoing a Non stress Test
2. It will last for a period of 30 -40 minutes .
3. The Non stress test will be performed to asses the effectiveness to the experimental group |
| Comparator Agent |
standard care |
The subjects in the comparison group (control group ) will undergo the routine Non stress test |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal mothers above 32weeks of gestation attending antenatal OPD , PGIMER, Chandigarh |
|
| ExclusionCriteria |
| Details |
Antenatal mother with Psychotic disorder |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Effect of progressive muscle relaxation exercise on the non stress test result |
30-40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mothers anxiousness and apprehension is reduced.
2. feels relaxed after performing progressing muscle relaxtion technique.
|
30 - 40 minutes |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this study, 60 antenatal mothers will be taught a progressive muscle relaxation technique which they will perform prior to Non stress test , which will take a time period of 10-30 minutes , after which the effectiveness of progressive muscle relaxation technique will be assessed on the reactivity and time consumption of non stress test . On the other hand 60 antenatal mothers who are in control group will be provided only the routine care and non stress test will be performed . The result is Reactive if the fetal heart rate has two episode of accelerations that are 15 seconds duration and 15 bpm above baseline of the fetal heart rate in 10 minutes extendible to 30 minutes (Acceleration : It refers to a visually apparent abrupt increase in fetal heart rate and peak which must be greater than or equal to 15 beats per minutes for 15 seconds) It is effective if the reactivity of the non stress test is within a time period of 30 minutes which is observed by a graphical record of the Non stress test . It is non reactive if there is less than 2 accelerations or acceleration less than 15 beats per minute or less than 15 seconds duration over a 30 minutes period .
Thus , we will be able to assess the effectiveness of progressive muscle relaxation technique among the antenatal mother on the reactivity and time consumption of non stress test .
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