| CTRI Number |
CTRI/2024/08/072525 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Cold Hip Bath on primary dysmenorrhea |
|
Scientific Title of Study
|
Effect of Cold Hip Bath on Pain, Menstrual Symptom, and Sleep Quality in University Students with Primary Dysmenorrhea: A Randomized Control Trial |
| 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 Sunita Sahish |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Shree Guru Gobind Singh Tricentenary University Gurugram, Haryana, India
Department of Naturopathy and Yogic Science, Room Number-310, B-Block, 3rd Floor, Gurugram, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
9664424906 |
| Fax |
|
| Email |
sunitasahish9493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Shree Guru Gobind Singh Tricentenary University Gurugram, Haryana, India
Department of Naturopathy and Yogic Science, Room Number-310, B-Block, 3rd Floor, Gurugram, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
8445464731 |
| Fax |
|
| Email |
suniljigyasu128@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Shree Guru Gobind Singh Tricentenary University Gurugram, Haryana, India
Department of Naturopathy and Yogic Science, Room Number-310, B-Block, 3rd Floor, Gurugram, Haryana, India
Gurgaon
HARYANA
122505
India |
| Phone |
8445464731 |
| Fax |
|
| Email |
suniljigyasu128@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Naturopathy and Yogic Sciences, SGT University Gurugram, Haryana, India 122505 |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Faculty of Naturopathy and Yogic Sciences, SGT University Gurugram, Haryana, India 122505 |
| Type of Sponsor |
Private medical college |
|
|
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 Sunita Sahish |
SGT University |
Department of Naturopathy & Yogic Science Hospital, SGT University
Gurgaon
HARYANA |
9664424906
sunitasahish9493@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Faculty of Naturopathy and Yogic Sciences SGT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E308||Other disorders of puberty, (2) ICD-10 Condition: E288||Other ovarian dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold Hip Bath |
The Hip Bath tub filled with cold water temperature 18-24°C generally 4-6 gallons of water are enough to cover hip duration 15 minutes. |
| Comparator Agent |
Control group |
Student will come to college on daily basis to attain the regular classes and follow daily regular activity and we are not giving any intervention called (control group) at the university and we will take pre and post data. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Age 18-30
Primary Dysmenorrhea.
University students.
Willing to participate. |
|
| ExclusionCriteria |
| Details |
Secondary Dysmenorrhea
Neurological disorder such as epilepsy, learning disabilities, neuromuscular disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Visual analogue scale (VAS)
2. Menstrual Symptom Questionnaire(MSQ) |
30 Days Pre and Post data will be collect |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh Sleep Quality Index (PSQI) |
30 Days Pre and Post data will be collect |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
23/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 randomized control trial (RCT) used Cold hip bath (Hydrotherapy) as an intervention to assess the effectiveness of cold hip bath in reducing intensity of menstrual pain with primary dysmenorrhea. As tool Visual analogue scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Pittsburgh Sleep Quality Index )PSQI) will be use in this study. |