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Motor Imagery Focused Pelvic Floor Exercises and Relaxation the Treatment of Dysmenorrhea Comparison of Exercises

Primary Purpose

Dysmenorrhea, Gynecologic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MOPEX Exercise
Relaxation Exercise
Combine Exercise
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Dysmenorrhea, Menstrual symptom, Imagination, Relaxation, Pelvic floor exercises, exercise

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Üsküdar UnıversıtyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Motor imagery focused pelvic floor exercise (MOPEXE)

Relaxation exercise (RE) group

Combined exercise group (CEG)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
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.
McGill pain questionnaire- short form
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.
Menstruation attitude scale (MBI)
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: Menstruation as a debilitating phenomenon (12 items), Menstruation as a disturbing phenomenon (6 items), Menstruation as a natural phenomenon (5 items), Noticing/anticipating that menstruation will occur (5 items), Denial of the effects of menstruation (7 items) The scale is evaluated by scoring between 1 and 7, and the Turkish form has been converted into scoring between 1 and 5. Participants are asked to mark the most appropriate option (1. Strongly disagree, 2. Disagree, 3. Undecided, 4. Agree, 5. Totally agree).
Functional and emotional dysmenorrhea scale (FEDS)
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06011928
Brief Title
Motor Imagery Focused Pelvic Floor Exercises and Relaxation the Treatment of Dysmenorrhea Comparison of Exercises
Official Title
Motor Imagery Focused Pelvic Floor Exercises and Relaxation the Treatment of Dysmenorrhea Comparison of Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the effects of motor imagery focused pelvic floor exercises and relaxation exercises used in the treatment of dysmenorrhea on pain and menstrual symptoms.
Detailed Description
Quantitative research methods were used in the study and it was a randomized type study. The sample of the study consisted of women between the ages of 18-30 who volunteered to participate in the study, showed symptoms of dysmenorrhea and can be accessed online. The names of female participants who volunteered to participate in the study and met the inclusion criteria were written on papers and put in a bag. Papers will be randomly selected by the evaluator by drawing lots. Participants will be randomly divided into 3 groups: motor imagery focused pelvic floor exercise group, relaxation exercise group, and combined group. Among the participants who agreed to participate in the study, the sociodemographic and menstrual characteristics information form and the Visual Analogue Scale value of 5 and above on the day when the menstrual cycle is most severe were included in the study, and the McGill Pain Questionnaire-Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) they will be asked to fill in. After the groups are formed, video home exercise programs will be delivered online (whatsApp, mail, etc.) to the participants. Individuals will be asked to apply the created video home exercise program individually in their own environment. Before the participants start their exercise programs, exercise programs will be taught by online interview. You will be asked to do the exercises for 8 weeks, 3 days a week. After the 8-week exercise program is over, the participants will be asked to fill in the McGill Pain Questionnaire- Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) on the day when the menstrual pain is most severe. Pre- and post-intervention data were statistically analyzed and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Gynecologic Disease
Keywords
Dysmenorrhea, Menstrual symptom, Imagination, Relaxation, Pelvic floor exercises, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor imagery focused pelvic floor exercise (MOPEXE)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Relaxation exercise (RE) group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Combined exercise group (CEG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MOPEX Exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Relaxation Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Combine Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
10 weeks
Title
McGill pain questionnaire- short form
Description
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.
Time Frame
10 weeks
Title
Menstruation attitude scale (MBI)
Description
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: Menstruation as a debilitating phenomenon (12 items), Menstruation as a disturbing phenomenon (6 items), Menstruation as a natural phenomenon (5 items), Noticing/anticipating that menstruation will occur (5 items), Denial of the effects of menstruation (7 items) The scale is evaluated by scoring between 1 and 7, and the Turkish form has been converted into scoring between 1 and 5. Participants are asked to mark the most appropriate option (1. Strongly disagree, 2. Disagree, 3. Undecided, 4. Agree, 5. Totally agree).
Time Frame
10 weeks
Title
Functional and emotional dysmenorrhea scale (FEDS)
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
dysmenorrhea is a female disease
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda KOÇOĞLU
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Üsküdar Unıversıty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34383437
Citation
McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.
Results Reference
background
PubMed Identifier
35419791
Citation
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.
Results Reference
background
PubMed Identifier
18620466
Citation
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.
Results Reference
background
PubMed Identifier
31538328
Citation
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.
Results Reference
background
PubMed Identifier
37555833
Citation
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.
Results Reference
background
PubMed Identifier
34360122
Citation
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.
Results Reference
background

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Motor Imagery Focused Pelvic Floor Exercises and Relaxation the Treatment of Dysmenorrhea Comparison of Exercises

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