- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530381
Effects of Pilates Exercises Applied With Face-to-Face and Telerehabilitation on Menstrual Pain
March 13, 2025 updated by: Duygu Şahin Altaç, Halic University
Comparison of the Effects of Pilates Exercises Applied With Face-to-Face and Telerehabilitation Methods on Menstrual Pain
Pain is one of the most common symptoms of menstrual syndrome that significantly affects quality of life.
The aim of our study is to compare the effect of Pilates on menstrual pain and the effectiveness of the applications within themselves.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
20 women experiencing severe pain during menstruation were randomized into two groups.
The same exercise program is applied to 10 participants face-to-face, and to 10 participants via telerehabilitation.
Exercises are applied for 6 weeks, 2 days a week.
Visual Analog Scale (VAS) is used for pain assessment, SF-36 Short Form is used to assess quality of life, and Menstrual Attitude Scale is used to assess symptoms in the premenstrual/menstrual period.
Evaluations are performed twice in total, before and after treatment.
Statistical analysis will be performed with SPSS 24.0 program.
If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation.
If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.
Study Type
Interventional
Enrollment (Actual)
20
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
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-
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Istanbul, Turkey
- Halic University
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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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- People between the ages of 18-30 who have a continuing menstrual cycle.
- Women with menstrual pain VAS>5.
- People with regular menstrual cycles.
Exclusion Criteria:
- Being in menopause.
- Using birth control pills.
- Taking hormone therapy.
- Having exercise intolerance.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Pilates Exercises Applied With Face-to-Face
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The exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period.
Exercises are performed face to face.
|
|
Experimental: Group 2
Pilates Exercises Applied With Telerehabilitation
|
The exercise program includes a warm-up period; exercises performed in the supine position, bridge, side-lying position, prone position, quadripedal position and sitting positions, and a cool-down period.
Exercises are performed as telerehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: at baseline and at week 6.
|
VAS is used for subjective assessment of pain.
VAS scores are evaluated on a scale of 1-10.
1-3 indicates mild pain, 4-6 indicates moderate pain, 7-8 indicates severe pain, and 9-10 indicates very severe and unbearable pain.Individuals with VAS>5 are included in the study.
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at baseline and at week 6.
|
|
Short-Form 36 (SF-36)
Time Frame: at baseline and at week 6.
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The SF-36 scale is used for quality of life assessment.
This scale basically includes 8 subject scales.
Each subject title is scored between 0-100.
The scale has positive scoring, as the score increases, the quality of life also increases.
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at baseline and at week 6.
|
|
Menstrual Attitude Scale (MAS)
Time Frame: at baseline and at week 6.
|
MAS is used to evaluate symptoms in the premenstrual/menstrual period.
MAS consists of 5 main topics and a total of 33 sub-items.
MAS is a scale that includes both positive and negative items.
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at baseline and at week 6.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duygu Şahin Altaç, PT, MSc., Halic 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
- Unsal A, Ayranci U, Tozun M, Arslan G, Calik E. Prevalence of dysmenorrhea and its effect on quality of life among a group of female university students. Ups J Med Sci. 2010 May;115(2):138-45. doi: 10.3109/03009730903457218.
- Daley A. The role of exercise in the treatment of menstrual disorders: the evidence. Br J Gen Pract. 2009 Apr;59(561):241-2. doi: 10.3399/bjgp09X420301. No abstract available.
- Kirthika S V, S S, G MK, S R, Rnv D, P SS. Comparing Pilates and Gym Ball Exercises for Primary Dysmenorrhea Management: An Empirical Study. Cureus. 2024 Apr 28;16(4):e59184. doi: 10.7759/cureus.59184. eCollection 2024 Apr.
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)
June 10, 2024
Primary Completion (Actual)
July 22, 2024
Study Completion (Actual)
September 10, 2024
Study Registration Dates
First Submitted
July 28, 2024
First Submitted That Met QC Criteria
July 28, 2024
First Posted (Actual)
July 31, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28.07.2024-MÜ
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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