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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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