Combined Effects of Barre and Gym Ball Exercises in Primary Dysmenorhoea

Not Applicable

Recruiting

• Conditions: Dysmenorrhea Primary

• Registration Number: NCT06750393
• Lead Sponsor: Riphah International University

Brief Summary

Group A will be given Barre and gym ball exercises. Group B will be given Barre exercises. All these sessions will be of 30-minute 3session per week for 12 weeks.

Detailed Description

This will be a randomized controlled trial conducted on 42 participants. Data will be collected from USKT (University of Sialkot) and UMT (University of Management and Technology Sialkot by using non-probability convenience sampling technique. WaLLiD score scale is used to determine the severity of dysmenorrhoea. Girls between the age of 17 to 25 with history of dysmenorrhea will be included in this study. Participants who has history of secondary dysmenorrhea, Diagnosed with polycystic ovarian syndrome will be excluded from this study. A sample of 42 will be divided in to two groups with 21 participants in each group. Group A will be given Barre and gym ball exercises. Group B will be given Barre exercises. All these sessions will be of 30 minute 3session per week for 12 weeks. Pre and post assessment of pain, distress , severity of dysmenorrhoea and quality of life will be done by using numeric pain rating scale, menstrual distress questionnaire, WaLLiD scale and Q-LES-Q-SF questionnaire. Data will be analyzed by using SPSS version 26.0.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• Female suffered from primary dysmenorrhea diagnosed through WaLLiD score range from 5-12
• Female having 5 and above score on Numerical Pain Rating Scale
• Female having regular menstrual period form at least 3 months
• Female having a history of dysmenorrhea occurring at least three times in the past six months

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Exclusion Criteria

• Females using hormonal contraception.
• Females who are married.
• Females with secondary dysmenorrhea
• Females diagnosed with polycystic ovarian syndrome
• Females having menstrual issues
• Females who take analgesic
• Females having BMI > 25
• Participants who show unwillingness to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numeric Pain rating Scale	12th week	Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain. Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable. It has good reliability of 0.79 and validity of 0.96.
Menstrual distress questionnaire (MEDI-Q):	12th week	The Menstrual Distress Questionnaire (MEDI-Q) is a newly developed tool that has been validated for comprehensive evaluation of menstrual-related distress .It consists of 25 items that cover different areas of menstruation-related symptoms, such as pain, discomfort, psychic or cognitive changes, and gastrointestinal disturbances. In this scale 0 -16 score indicates Mild symptoms, indicating minimal distress,17-34 indicates Moderate symptoms, indicating moderate distress.35-56 indicates Severe symptoms. It is reliable tool with reliability 0.84 and validity 0.95.
Quality Of Life Enjoyment And Satisfaction Questionnaire Short Form(Q-LESQ-SF)	12th week	Short-Form (Q-LES-Q-SF) was derived from the general activities scale of the original 93- item questionnaire. It consists of 16 items but only 14 item scores are computed, the last two are stand-alone items. Q-LES-Q-SF is rated on a 5-point scale as 1-very poor, 2-poor, 3-fair, 4-good, and 5-very good. 70 is the maximum score. It is a reliable and valid tool with values 0.9 and 0.93.
WaLLiD Score	12th week	WaLLiD score was designed to diagnose dysmenorrhea and predict medical leave score as a standard survey that validated and constructed the classification of the severity of dysmenorrhea. The interpretation of the WaLLiD questionnaire is as follows: 0 = No dysmenorrhea 1-4 =Mild dysmenorrhea 5-7 = Moderate dysmenorrhea 8-12 = Severe dysmenorrhea WaLLiD score is reliable tool with value of 0.723

Trial Locations

Locations (1)

University of Sialkot, University of Management Technology; 🇵🇰 Sialkot, Pjunjab, Pakistan