- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314021
Primary Dysmenorrhea and Mobilization.
Comparison of the Structured FEMOB Mobilization Technique and the MOPEXE Exercise Model in Women With Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34000
- Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- primary dysmenorrhea
Exclusion Criteria:
- a contraindicated condition
Study Plan
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 |
|---|---|
|
Active Comparator: FEMOB
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes. Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes. Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes. FEMOB is a mobilization model that includes temporo-mandibular, occipito-sacral, and sacroiliac joint mobilizations along with abdominal myofascial release and kinesio taping. |
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes.
Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes.
Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes. 5 minute-Meditation Therapy 10 minute-Progressive Relaxation training ( Bernstein-Borkovec Method) 5 min - Breathing Exercises (Diaphragmatic Breathing Exercise, Pursed lip breathing Exercise) 35 min -Motor Imagery Technique Focused Pelvic Floor Exercises-MOPEXE 5 min - Meditation Therapy Twice a week for 60 minutes 12 weeks Participants will be evaluated online at the beginning of the research and at the end of the 12-week program.
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes.
Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes.
Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes.
|
|
Active Comparator: MOPEXE
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes. Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes. Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes. 5 minute-Meditation Therapy 10 minute-Progressive Relaxation training ( Bernstein-Borkovec Method) 5 min - Breathing Exercises (Diaphragmatic Breathing Exercise, Pursed lip breathing Exercise) 35 min -Motor Imagery Technique Focused Pelvic Floor Exercises-MOPEXE 5 min - Meditation Therapy Twice a week for 60 minutes 12 weeks Participants will be evaluated online at the beginning of the research and at the end of the 12-week program. |
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes.
Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes.
Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes.
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes.
Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes.
Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes.
FEMOB is a mobilization model that includes temporo-mandibular, occipito-sacral, and sacroiliac joint mobilizations along with abdominal myofascial release and kinesio taping.
|
|
Other: CONTROL
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes.
Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes.
Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes.
|
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes.
Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes.
Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes. 5 minute-Meditation Therapy 10 minute-Progressive Relaxation training ( Bernstein-Borkovec Method) 5 min - Breathing Exercises (Diaphragmatic Breathing Exercise, Pursed lip breathing Exercise) 35 min -Motor Imagery Technique Focused Pelvic Floor Exercises-MOPEXE 5 min - Meditation Therapy Twice a week for 60 minutes 12 weeks Participants will be evaluated online at the beginning of the research and at the end of the 12-week program.
Transcutaneous Electrical Nerve Stimulation (TENS) treatment will be applied to the lumbar and suprapubic areas using 2 channels and 4 electrodes.
Conventional TENS (120 Hz) will be applied simultaneously to the lumbar and suprapubic areas for 30 minutes.
Hot pack application will be done sequentially to the lumbar and suprapubic areas for 15 minutes each, for a total of 30 minutes.
FEMOB is a mobilization model that includes temporo-mandibular, occipito-sacral, and sacroiliac joint mobilizations along with abdominal myofascial release and kinesio taping.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
McGill pain scale short form
Time Frame: 5 minutes
|
The characteristic of pain felt by the patients during menstruation was evaluated using the McGill Pain Questionnaire-Short Form,With the McGill Melzack Pain Questionnaire, the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of viable pain for the individual are determined.
High score indicates high level of pain
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menstrual Attitude Questionnaire
Time Frame: 5 minutes
|
The Turkish version of the Menstrual Attitude Scale (MBI) will be applied to determine the attitudes and behaviors of the participants during the menstrual period. Menstruation attitude scale includes 5 subtitles. These subheadings are;
|
5 minutes
|
|
Functional and Emotional Dysmenorrhea Scale
Time Frame: 5 minutes
|
This is a 14-item, 5-point Likert-type scale used to measure dysmenorrhea functionally and emotionally.
There are no reverse items in the scale.
The scale was developed to provide functional and emotional measurement of dysmenorrhea.
As the scores obtained from the scale increase, the extent to which patients are functionally and emotionally affected by dysmenorrhea also increases.
|
5 minutes
|
|
Menstrual Symptom Questionnaire
Time Frame: 5 minutes
|
The scale consists of 22 items that inquire about menstrual symptoms and is scored on a five-point Likert scale, from never (1) to always (5).
The scale, which consists of three sub-dimensions, is evaluated in the sub-dimension of 'Negative effects/somatic complaints' with items 1-13, the sub-dimension of 'Menstrual pain symptoms' with items 14-19, and the sub-dimension of 'Coping methods' with items 20-22.
An increase in the mean score indicates an increase in the severity of menstrual symptoms related to the relevant sub-dimension.
|
5 minutes
|
|
The Menstrual Distress Questionnaire
Time Frame: 5 minutes
|
This is a self-reported assessment tool designed to comprehensively evaluate the physical and emotional symptoms experienced by individuals during their menstrual period.
The scale consists of 25 questions, each with 5 sub-items, covering common symptoms such as abdominal pain, headache, nausea, irritability, and mood swings.
Each item is scored using a Likert-type rating system to determine the frequency or severity with which the participant experiences the relevant symptom.
As the total score on the scale increases, the intensity of the symptoms experienced during menstruation and their negative impact on daily life also increase.
In this context, high scores indicate increased symptom severity and decreased quality of life.
The scale offers a holistic assessment by encompassing both the somatic and emotional dimensions of menstruation-related symptoms.
|
5 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-4605
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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