| CTRI Number |
CTRI/2024/04/065289 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Jacobson Relaxation Technique in Dysmenorrhea |
|
Scientific Title of Study
|
Effect of Jacobson Relaxation Technique on Sleep Quality and Fatigue in Dysmenorrhoea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharlin Singhal |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
Haryana
India
Hisar
HARYANA
125001
India |
| Phone |
9350251124 |
| Fax |
|
| Email |
sharlinsinghal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheswar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and University
Hisar
Haryana
India
Hisar
HARYANA
125001
India |
| Phone |
9416665373 |
| Fax |
|
| Email |
jyotisabharwal35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti PT |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheswar University of Science and Technology |
| Address |
Guru Jambheshwar University of Science and University
Hisar
Haryana
India
Hisar
HARYANA
125001
India |
| Phone |
9416665373 |
| Fax |
|
| Email |
jyotisabharwal35@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharlin Singhal BPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technologyy |
| Address |
New Delhi-Sirsa Highway Hisar- 125001 Haryana India |
| Type of Sponsor |
Other [Goverment University] |
|
|
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 |
| Sharlin Singhal |
Room no.5 OPD Department of Physiotherapy |
Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
Hisar
HARYANA |
9350251124
sharlinsinghal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Deep breathing exercise |
| Intervention |
Jacobson technique |
Jacobson Relaxation Technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
menarche at or after 12 years
Regular cycle of menstruation [25 to 30 days]
Does not take analgesics
Regular menstruation phase[5 to 8 days]
Menstrual cycles of around 28 to 30 days for the last six months |
|
| ExclusionCriteria |
| Details |
Practicing another exercise
Unable to participate in the study dur to health deviations
Diagnosed with PMS
Physically challenged |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep Quality Scale |
The outcome will be assessed before the treatment and after the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue Assessment Scale |
The outcome will be assessed before the treatment and after the treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="3"
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
|
It is a randomised controoled trial with a duration of 2 weeks and involving 60 patients that will be divided into two groups based on lottery method. Its intervention involves jacobson relaxation technique and deep breathing exercise . Pre and post intervetion reading of the outcome variables include sleep quality scale and fatigue assessment scale will be taken. The intervention will be given for 5 days in a week for 15 to 20 minutes for 2 weeks. |