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Clinical Trials/CTRI/2024/12/078839
CTRI/2024/12/078839Not yet recruitingNot Applicable

Effect Of Brain Gym Exercises On Sleep And Severity Of Dysmenorrhea In Females

Punita Saini1 site in 1 country50 target enrollmentStarted: February 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
19.00 Year(s) to 24.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • WaLIDD more than 4 DASS21 less than the moderate score.

Exclusion Criteria

  • 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}).

Outcomes

Primary Outcomes

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.

Time Frame: 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 Outcomes

  • Pittsburgh Sleep Quality Index (PSQI)(Pre intervention before 4 weeks)

Investigators

Sponsor
Punita Saini
Sponsor Class
Other [self ]
Responsible Party
Principal Investigator
Principal Investigator

Punita Saini

GD Goenka University

Study Sites (1)

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