CTRI

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CTRI Number

CTRI/2025/12/099321 [Registered on: 17/12/2025] Trial Registered Prospectively

Last Modified On:

16/12/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Single Arm Study

Public Title of Study

Effect Of Brain Gym Exercise On Sleep Quality In Young Girls With Dysmenorrhea

Scientific Title of Study

Effect Of Brain Gym Exercise On Sleep Quality In Young Girls With Primary Dysmenorrhea- A Quasi Experimental Study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Gauri Sakharekar
Designation	Intern
Affiliation	PES Modern College of Physiotherapy
Address	Department of physiotherapy PES Modern College of Physiotherapy Shivajinagar Pune-411005 Maharashtra India Department of physiotherapy PES Modern College of Physiotherapy Shivajinagar Pune-411005 Maharashtra India Pune MAHARASHTRA 411005 India
Phone	9422878866
Fax
Email	gaurisakharekar@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shruti Mankar
Designation	professor
Affiliation	PES Modern College of Physiotherapy
Address	Department of physiotherapy PES Modern College of Physiotherapy Shivajinagar Pune-411005 Maharashtra India Department of physiotherapy PES Modern College of Physiotherapy Shivajinagar Pune-411005 India Pune MAHARASHTRA 411005 India
Phone	7276020635
Fax
Email	mankarshutee@gmail.com

Details of Contact Person
Public Query

Name	Dr Shruti Mankar
Designation	professor
Affiliation	PES Modern College of Physiotherapy
Address	Department of physiotherapy PES Modern College of Physiotherapy Shivajinagar Pune-411005 Maharashtra Department of physiotherapy PES Modern College of Physiotherapy Shivajinagar Pune-411005 Maharashtra India Pune MAHARASHTRA 411005 India
Phone	7276020635
Fax
Email	mankarshutee@gmail.com

Source of Monetary or Material Support

PES Modern college of physiotherapy OPD Shivaji Nagar Pune 411005 India

Primary Sponsor

Name	NIL
Address	NIL
Type of Sponsor	Other [NIL]

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
Gauri Sakharekar	PES Modern college of physiotherapy	Department of physiotherapy PES modern college pf physiotherapy Shivaji Nagar pune Pune MAHARASHTRA	9422878866 gaurisakharekar@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethical Committee PES Modern College Of Physiotherapy	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Primary Dysmenorrhea

Intervention / Comparator Agent

Type	Name	Details
Intervention	Brain Gym Exercises	Brain Gym Exercises are movements that connect body and mind, consists of physical and mental strategies. Brain gym Exercises are known to have an effect on sleep quality, attention, memory and concentration. Brain Gym Exercises for 3 times per week for 8 weeks, session duration of 25-30 minutes .
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	19.00 Year(s)
Age To	21.00 Year(s)
Gender	Female
Details	Girls with primary dysmenorrhea, diagnosed by using WaLIDD Score. Young girls with sleep disturbed diagnosed using PSQI.

ExclusionCriteria

Details

Girls with PCOS
Girls with secondary dysmenorrhea
Girls having primary dysmenorrhea but sleep is not affected
Girls with any other gynecological conditions
any neurological condition
psychological condition such as anxiety, depression.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Pittsburg Sleep Quality Index , Number of sleep hours	Pittsburg Sleep Quality Index 4 weeks and 8 weeks Number of sleep hours 4 weeks and 8 weeks

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="45"
Sample Size from India="45"
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)

08/01/2026

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="5"
Days="30"

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

This quasi experimental single arm study investigates the effect of an 8 week Brain Gym exercise intervention on sleep quality among 45 young girls aged 19 to 21 years with primary dysmenorrhea and disturbed sleep in Pune India. Participants diagnosed with mild moderate primary dysmenorrhea WaLIDD score 1 to 7 and sleep disturbance PSQI score 0 to 3 will receive 24 sessions of slow paced Brain Gym exercises 3 sessions per week involving deep breathing and whole body relaxation techniques. Primary outcome is Pittsburgh Sleep Quality Index PSQI total score and secondary outcome is average sleep duration hours per night measured at baseline 4 weeks and 8 weeks. Exclusion criteria include PCOS secondary dysmenorrhea neurological psychological conditions current exercise programs or dysmenorrhea medications. Statistical analysis will use Wilcoxon signed rank test for PSQI scores and paired t test for sleep duration conducted over 6 months in a Pune rehabilitation setting.