| CTRI Number |
CTRI/2024/12/078839 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| 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 Brain Gym Exercises On Sleep And Severity Of Menstrual Pain In Females |
|
Scientific Title of Study
|
Effect Of Brain Gym Exercises On Sleep And Severity Of Dysmenorrhea In Females |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Punita Saini |
| Designation |
MPT scholar |
| Affiliation |
GD Goenka University |
| Address |
D Goenka Memorial Health and wellness Centre/ Neurology Department/Room no. 421 A
GD Goenka University Sohna Gurgaon Road Sohna, Haryana 122103
Gurgaon HARYANA 122103 India |
| Phone |
8302965527 |
| Fax |
|
| Email |
punnisaini1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sheetal Malhan |
| Designation |
Associate Professor |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University Sohna Gurgaon Road Sohna Haryana
Gurgaon HARYANA 122103 India |
| Phone |
9927959575 |
| Fax |
|
| Email |
sheetal.malhan@gdgu.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Manish Kumar |
| Designation |
Associate Professor |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University Sohna Gurgaon Road Sohna Haryana
Gurgaon HARYANA 122103 India |
| Phone |
9582553124 |
| Fax |
|
| Email |
manish.kumar4@gdgu.org |
|
|
Source of Monetary or Material Support
|
| GD Goenka University Sohna Gurgaon Road Sohna Haryana India 122103 |
|
|
Primary Sponsor
|
| Name |
Punita Saini |
| Address |
GD Goenka University Sohna Gurgaon Road Sohna Haryana India 122103 |
| 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 |
| Dr Punita Saini |
GD Goenka University |
GD Goenka Memorial Health and wellness Centre/ Neurology Department/Room no. 421 A Gurgaon HARYANA |
8302965527
punnisaini1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Waves Women Empowerment Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain gym exercises |
With every brain gym ex. for 3-5 min., 2 times a day, 5 dynamic sessions each week, each lasting 30 minutes. For 4 weeks |
| Comparator Agent |
general counselling |
breathing ex. for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
WaLIDD more than 4
DASS21 less than the moderate score |
|
| ExclusionCriteria |
| Details |
Females on oral contraceptives, birth pills.
Ongoing psychological counselling, cognitive damage, and undertaking psychotic drugs.
Pregnant or breastfeeding females.
Females on hormonal replacement therapy.
Females having any neurological disorders like MS, narcolepsy etc.
Females suffering from any psychological disorders like anxiety, depression, etc, (DASS 21- with the scoring of more than- depression {10-13}, anxiety {8-9} and stress {15-18}). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WaLIDD Score will be used to measure the severity of dysmenorrhea. The score will be used pre intervention as a baseline assessment and after the intervention to check the effect of intervention. |
WaLIDD Score will be used as a baseline assessment prior to the intervention and after 4 weeks of intervention this score will be used to measure the effect of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh Sleep Quality Index (PSQI) |
Pre intervention before 4 weeks
post intervention after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/02/2025 |
| 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="0" Months="1" 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
Modification(s)
|
This study is
designed to address pain and poor sleep experienced during menstruation by
using a randomized selection process for participants. Each participant will be
evaluated based on their scores on the WaLIDD (Working Ability, Location,
Intensity, Days of pain, and Dysmenorrhea) scale and the DASS-21 (Depression
Anxiety Stress Scale) to ensure they meet the criteria for inclusion.
Participants scoring less than 4 on the WaLIDD scale or those in the
"moderate" category or more on the DASS-21 will not be included in
the study, as the focus is on those with more severe symptoms. This approach
ensures that the study targets individuals who could benefit most from
potential relief strategies.
Intervention
· Participants
will be randomly selected using the chit method to ensure a fair and unbiased sampling
process. Each participant will be evaluated using the WaLIDD (Working Ability,
Location, Intensity, Days of Pain, and Dysmenorrhea) scale and the DASS-21
(Depression Anxiety Stress Scale) to determine eligibility.
· Inclusion
Criteria:
Participants scoring 4 or higher on the WaLIDD scale and falling in the
"normal" or "mild" category on the DASS-21 will be
included, as the study focuses on individuals with severe menstrual pain but
without significant psychological distress.
· Exclusion
Criteria:
Participants scoring less than 4 on the WaLIDD scale or classified as
"moderate" or higher on the DASS-21 will not be included.
· Eligible
participants will be divided into two groups:
· Experimental
Group: Participants will be asked to fill the WaLIDD and PSQI to measure the
pre- intervention scores. Then the Brain Gym exercises over the course of 4
weeks, participants will be told:
o
Perform Brain Gym exercises for 3–5
minutes, twice daily. Attend 5 dynamic sessions per week, each lasting 30
minutes.
· Control
Group: same for the pre- intervention scores WaLIDD and PSQI will be filled. Participants
will be given general counselling. For e.g. breathing ex.
· Pre-and
post-intervention assessments will be conducted for both groups using the
following tools:
· WaLIDD
Scale to measure menstrual pain severity.
· Pittsburgh
Sleep Quality Index to assess the participant’s sleep quality
· The
comparison of pre- and post-intervention scores between the experimental and
control groups will help evaluate the effectiveness of Brain Gym exercises on
reducing menstrual pain severity and improving sleep quality.
·
The
comparison of these scores will help us to evaluate the impact of Brain Gym
exercises on menstrual pain severity and sleep quality. |