- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06011928
MOPEXE and RE in Treating Dysmenorrhea
Comparison Of Motor Imagery Focused Pelvic Floor Exercises And Relaxation Exercises For Treating Dysmenorrhea: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ömer ŞEVGİN
- Phone Number: +905069787535
- Email: omer.sevgin@uskudar.edu.tr
Study Locations
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Istanbul, Turkey
- Üsküdar Unıversıty
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Contact:
- Ömer ŞEVGİN
- Phone Number: +905069787535
- Email: omer.sevgin@uskudar.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a normal menstrual cycle (24-35 days),
- never having given birth
- According to the Visual Analogue Scale (VAS), the pain level during the menstruation period is 10.
- to give a score of 5 or more out of cooperative and oriented
- Volunteer to participate in the study.
Exclusion Criteria:
- Having an active sexual life
- Receiving psychiatric treatment for stress disorder or anxiety, using birth control pills,
- Those with irregular menstrual cycles (less than 21 days or longer than 35 days)
- those with a menstrual cycle period),
- undergoing any gynecological surgery,
- A mental, cardiovascular, pulmonary, or orthopedic disorder that may interfere with exercise have a disease
Study Plan
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 |
---|---|
Active Comparator: Motor imagery focused pelvic floor exercise (MOPEXE)
Internal imagery technique, one of the imagery techniques, will be applied to the participants. Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds. |
Exercises to be done in order:
Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds |
Active Comparator: Relaxation exercise (RE) group
One of the relaxation methods, Progressive Relaxation Exercises will be used.Exercises will be required to be applied 3 days a week, as 1 set of 10 repetitions per day.
|
Progressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling.
will be displayed.
Each muscle is contracted for 5 seconds and relaxed for 10 seconds.
will be held.
Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced.
After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened.
|
Active Comparator: Combined exercise group (CEG)
With the video home exercise program, the participants performed progressive relaxation exercises, respectively.
then they will be provided with motor imagery focused pelvic floor exercises.
A rest period of 5 minutes will be applied between two different exercise programs.
|
Exercises to be done in order: Pelvic tilt in supine position Bridge building Pelvic stretching Ball spin Cat-camel exercise Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds. Progressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling. will be displayed. Each muscle is contracted for 5 seconds and relaxed for 10 seconds. will be held. Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced. After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale
Time Frame: 10 weeks
|
The VAS was used on the most severe day of the menstrual cycle to determine the severity of pain, which is one of the inclusion criteria of the participants before starting the study.
Subjects were asked to mark the degree of pain they felt on a straight line of 100 millimeters (mm).
A 0 at the beginning means no pain and a maximum of 10 at the end of the line means unbearable pain.
The point determined on the line expresses the intensity of pain that people feel during menstruation.
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10 weeks
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McGill pain questionnaire- short form
Time Frame: 10 weeks
|
It is a questionnaire used to describe the severity and quality of the pain that a person feels during menstruation.
A high score indicates a high level of pain.
The questionnaire consists of three parts.
In the first part, there are 15 descriptive word groups, 11 of which are to evaluate the emotional/perceptual dimension of pain and 4 to evaluate the emotional/emotional dimension of pain.
Words are rated from 0 to 3 (0= None at all, 1= Mild, 2=Moderate, 3= Severe).
In the first part, three pain scores are obtained: sensory pain score, perceptual pain score and total pain score.
Pain quality scores are obtained with sensory/perceptual 0-33 points, emotional/emotional 0-12 points, and a total of 0-45 points.
The second part is the display of the pain intensity of his work on a scale.
A low value indicates a low level of pain, and a high value indicates severe.
The third section has five word groups ranging from 'mild pain' to 'unbearable pain' to describe one's pain.
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10 weeks
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Menstruation attitude scale (MBI)
Time Frame: 10 weeks
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It is used to evaluate the positive / negative aspects of menstruation. The scale is a Likert-type scale consisting of 33 items and five subscales. The subscales and the items of the subscales are as follows:
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10 weeks
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Functional and emotional dysmenorrhea scale (FEDS)
Time Frame: 10 weeks
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Evaluates dysmenorrhea functionally and emotionally.
It consists of 14 items and 2 sub-dimensions.
In the scale, each item is scored between 1 and 5 (1.
Not at all similar to my situation, 2.
Not similar to my situation, 3. Similar or not similar to my situation, 4. Considered similar to my situation, 5. Very similar to my situation).
The presence of a high score indicates that the level of functional and emotional impact of dysmenorrhea is high.
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10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Selda KOÇOĞLU, Uskudar University
Publications and helpful links
General Publications
- Armour M, Ee CC, Naidoo D, Ayati Z, Chalmers KJ, Steel KA, de Manincor MJ, Delshad E. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2019 Sep 20;9(9):CD004142. doi: 10.1002/14651858.CD004142.pub4.
- Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.
- McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.
- Boztas Elverisli G, Armagan N, Atilgan E. Comparison of the efficacy of pharmacological and nonpharmacological treatments in women with primary dysmenorrhea: randomized controlled parallel-group study. Ginekol Pol. 2022 Apr 14. doi: 10.5603/GP.a2022.0009. Online ahead of print.
- Daley AJ. Exercise and primary dysmenorrhoea : a comprehensive and critical review of the literature. Sports Med. 2008;38(8):659-70. doi: 10.2165/00007256-200838080-00004.
- Fuentes-Aparicio L, Cuenca-Martinez F, Munoz-Gomez E, Molla-Casanova S, Aguilar-Rodriguez M, Sempere-Rubio N. Effects of Therapeutic Exercise in Primary Dysmenorrhea: An Umbrella & Mapping Review Therapeutic Exercise in Primary Dysmenorrhea. Pain Med. 2023 Aug 9:pnad104. doi: 10.1093/pm/pnad104. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UskudarU65
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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