| CTRI Number |
CTRI/2024/04/065855 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Brain gym exercises on menstrual distress |
|
Scientific Title of Study
|
Effect of brain gym exercises on menstrual distress- A randomized controlled 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 |
Anushka Sawant |
| Designation |
Post Graduate Student |
| Affiliation |
Kaher Institute of physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no 39 Sagar Floor KLE Dr Prabhakar Kore Hospital and MRC, Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8828995848 |
| Fax |
|
| Email |
anu.sawant1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Bulbuli |
| Designation |
Associate Professor |
| Affiliation |
Kaher Institute of physiotherapy |
| Address |
Advanced physiotherapy centre,room no 39 sagar floor KLE Dr Prabhakar Kore Hospital and MRC Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Bulbuli |
| Designation |
Associate Professor |
| Affiliation |
Kaher Institute of physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no 39 sagar floor
KLE Dr Prabhakar Kore Hospital and MRC Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
Nehru nagar Belagavi |
| 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 |
| Anushka Sawant |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Advanced physiotherapy centre, room no 39, sagar floor, KLE Dr Prabhakar kore hospital and MRC Belgaum Karnataka 590010
Belgaum
KARNATAKA |
8828995848
anu.sawant1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, (2) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain gym exercises and Conventional Exercises |
Brain gym exercises and Conventional Exercises will be given for 4 weeks |
| Comparator Agent |
Conventional exercises |
Conventional exercises will be given for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Females within the age group of 18-25 years with one or more characteristics of menstrual distress
Female willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Females having secondary dysmenorrhea.
Females having menstrual abnormalities. Females taking pain-relieving medications.
Diagnosed cases of Polycystic ovary syndrome (PCOS).
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Menstrual Distress Questionnaire
2. Retrospective Symptom
Scale (RSS)
3. WaLIDD score |
at baseline
post intervention ( after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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 2 |
|
Date of First Enrollment (India)
|
27/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
Aim: To determine the effect of brain gym exercises on menstrual distress. Inclusion criteria: Females within the age group of 18-25 years with one or more characteristics of menstrual distress. Female willing to participate in the study Exclusion criteria: Females having secondary dysmenorrhea. Females having menstrual abnormalities. Females taking pain-relieving medications. Diagnosed cases of Polycystic ovary syndrome (PCOS).
Outcome measures Menstrual Distress Questionnaire Retrospective Symptom Scale (RSS) WaLIDD score
Procedure The study participants will be randomly allocated into two different groups. Group A will be administered with conventional exercises and Group B will be administered with bran gym exercises and conventional exercises
|