Functional Exercises With Water Intake in Primary Dysmenorrhea

Study Overview
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Brief Summary
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Dysmenorrhea and its associated symptoms are very common in women. In Pakistan, almost 78% of women report Primary Dysmenorrhea. This will be a randomized controlled trial with two parallel groups. one group will be receiving functional exercises along with water intake and the other will be receiving no interventions.

Detailed Description
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Mostly in the reproductive years of age women suffers from the Pain of Menstruation which is known as Dysmenorrhea. In Pakistan every other girl is silently suffers from this disease leading to the inefficiency and one of the main cause of school and work absenteeism. This novel study is designed to target the menstrual symptoms of women with functional exercises combine with optimal intake of water. The objective of this study is to determine the effects of functional exercises with water intake on menstrual symptoms and pain in Primary Dysmenorrhea. This is a Randomized controlled study. Before the study, all the participants will go through baseline evaluation, and then allocated to the groups. The exercise protocol consisting of the combination of exercises with regular intake of water (in bouts) will be informed to them. Females fulfilling the criteria and willing to participate in exercise trial will be recruited in the study. Outcome will be assessed at baseline and post treatment after 8th week.

Official Title
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Effect of Functional Exercises With Water Intake on Sleep Quality and Menstrual Symptoms in Primary Dysmenorrhea

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Other: Exercise and Water Intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group 15-35 Patients with pain at a severity level of 5 on NPRS during menstruation. Primary Dysmenorrhea diagnosis made on WALIDD score Patients having regular menstrual cycle Exclusion Criteria: Patients having some previous surgical history Patients diagnosed with Secondary Dysmenorrhea Abnormal Cognition Involved in any regular physical activity for last 6 months

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two parallel groups in the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>The exercise protocol for this group will be abdominals, pelvic stretching and kegels exercises (PFM) for three days/week lasting about 30 minutes with approximately 1600-1800ml (8-10 glasses) intake of water for 8 weeks (two consecutive menstrual cycles) Exercises include: Piriformis stretching (5 repetitions×20 seconds) Adductor stretching (5 repetitions×20 seconds) Sit-ups (10 repetitions×3 sets) Bridging (10 repetitions×3 sets) Kegels exercises (10 repetions×3 sets) Pelvic elevation (10 repetitions×3 sets) Pelvic rotation (10 repetitions×3 sets) Cobra pose (5 repetitions×20 seconds) | Other: Exercise and Water Intake<br>* The exercise protocol for this group will be abdominals, pelvic stretching and kegels exercises (PFM) for three days/week lasting about 30 minutes with approximately 1600-1800ml (8-10 glasses) intake of water for 8 weeks (two consecutive menstrual cycles) Exercises include: Piriformis stretching (5 repetitions×20 seconds) Adductor stretching (5 repetitions×20 seconds) Sit-ups (10 repetitions×3 sets) Bridging (10 repetitions×3 sets) Kegels exercises (10 repetions×3 sets) Pelvic elevation (10 repetitions×3 sets) Pelvic rotation (10 repetitions×3 sets) Cobra pose (5 repetitions×20 seconds)<br>|
| No Intervention: Group B<br>The participants in this group will be asked neither to do any exercise nor to change their daily basis routine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS) | The Numeric Pain Rating Scale (NPRS) (an outcome measure) is a one-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or worst pain imaginable). The intrarater reliability with ICC = 0.67. | changes from Baseline to 8th week | 
| Numeric Pain Rating Scale (NPRS) | The Numeric Pain Rating Scale (NPRS) (an outcome measure) is a one-dimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or worst pain imaginable). The intrarater reliability with ICC = 0.67. | Post 8 weeks | 
| Menstrual Symptom Questionnaire (MSQ) | The menstrual symptom questionnaire is a Psychometric test used to determine the menstrual symptoms. The questionnaire consists of 24 items | changes from Baseline to 8th week | 
| Menstrual Symptom Questionnaire (MSQ) | The menstrual symptom questionnaire is a Psychometric test used to determine the menstrual symptoms. The questionnaire consists of 24 items | post 8th week | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburg Sleep Quality Index (PSQI) is used to evaluate sleep quality with score ranging from 0 to 21. Higher scores indicate poor sleep quality | changes from Baseline to 8th week | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburg Sleep Quality Index (PSQI) is used to evaluate sleep quality with score ranging from 0 to 21. Higher scores indicate poor sleep quality | post 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional exercises, water intake, Menstrual Pain, Sleep