Functional Exercises With Water Intake in Primary Dysmenorrhea

July 28, 2022 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Fedral
      • Rawalpindi, Fedral, Pakistan, 46000
        • Behbud Association of Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

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

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)
No Intervention: Group B
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: changes from Baseline to 8th week
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)
Time Frame: Post 8 weeks
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)
Time Frame: changes from Baseline to 8th week
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)
Time Frame: post 8th week
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)
Time Frame: changes from Baseline to 8th week
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)
Time Frame: post 8th week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 7, 2022

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 024433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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