- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520136
Evaluation of the Effect of a Structured Yoga Exercise in Young Women With Primary Dysmenorrhea
Evaluation of the Effect of a Structured Yoga Exercise Program on Pain, Menstrual Symptoms, and Quality of Life in Young Women With Primary Dysmenorrhea
Abstract
Primary dysmenorrhea is a common gynecological condition affecting women of reproductive age and negatively impacting quality of life. It is characterized by cramping pain in the lower abdomen that may radiate to the lower back and thighs, leading to decreased daily functioning, academic performance, and psychological well-being. In addition to pharmacological treatments, complementary approaches are increasingly used in the management of dysmenorrhea. Yoga, a mind-body exercise that combines physical movement with mental focus, has been suggested as an effective method for reducing stress and pain associated with dysmenorrhea.
The aim of this study is to evaluate the level of awareness about dysmenorrhea in young women with primary dysmenorrhea and to investigate the effects of a yoga program on pain, quality of life, and menstrual attitudes following an educational session provided to all participants. Pain severity, quality of life, and menstrual attitudes will be assessed using validated questionnaires and scales, including the Visual Analog Scale (VAS), awareness questionnaire, functional and emotional dysmenorrhea scale, Menstrual Attitude Scale, and quality of life questionnaire.
This study aims to determine whether yoga exercises reduce dysmenorrhea symptoms and improve quality of life in young women with primary dysmenorrhea. Additionally, the study is expected to increase awareness about dysmenorrhea and provide evidence for the effectiveness of yoga as a non-pharmacological intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the effects of yoga exercise on dysmenorrhea symptoms in young women with primary dysmenorrhea. Additionally, the study aims to examine the effects of yoga exercises on participants' quality of life. Although dysmenorrhea is highly prevalent among young women, the use of non-pharmacological approaches for its management is considered limited. Therefore, a structured yoga exercise program will be applied to the participants in this study.
Pain intensity, quality of life, and menstrual attitudes of the participants will be evaluated. During the data collection process, Personal Information Form, Visual Analog Scale (VAS), Functional and Emotional Dysmenorrhea Scale, Menstrual Attitude Scale, and quality of life questionnaire will be used. Assessments will be performed before and after the exercise program.
This study aims to determine whether a yoga exercise program is effective in reducing pain and improving quality of life in young women with primary dysmenorrhea.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Recruiting
- Ankara University, Haymana Vocational School
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Contact:
- Ayşegül ATLI
- Phone Number: 05397610221
- Email: atlia@ankara.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy young women with primary dysmenorrhea
- Aged between 18-25 years
- Having a regular menstrual cycle (30-35 days)
- Menstrual bleeding duration of 3-10 days
Exclusion Criteria:
- Having secondary dysmenorrhea
- Participation in regular physical activity or other exercise programs
- Use of medication
- Diagnosed with polycystic ovary syndrome
- Having bleeding disorders
- Positive pregnancy test
- Being in the breastfeeding period
- Primary dysmenorrhea attributed to medical disorders or other causes
- Participants who miss three consecutive sessions or four alternating sessions during the study will be excluded from the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: control grup
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Experimental: Yoga Group
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Participants in the intervention group will receive a structured yoga exercise program.
The yoga program will include breathing exercises, relaxation techniques, and selected yoga postures targeting the pelvic region.
The exercises will be performed regularly for the duration of the study.
Pain intensity, quality of life, and menstrual attitudes will be evaluated before and after the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity (VAS)
Time Frame: Baseline and immediately after the 8-week intervention
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The Visual Analog Scale (VAS) was used to assess menstrual pain intensity.
Participants rated their pain on a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain severity.
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Baseline and immediately after the 8-week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome Measure: Participant Experiences
Time Frame: after 8 weeks of intervention
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A subset of participants from the yoga group participated in semi-structured interviews after the intervention to explore their perceptions and experiences related to therapeutic yoga.
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after 8 weeks of intervention
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Functional and Emotional Dysmenorrhea Scale
Time Frame: baseline and after 8 weeks of intervention
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The Functional and Emotional Dysmenorrhea Scale (FEDS) is a 14-item self-report questionnaire designed to assess the functional and emotional impact of primary dysmenorrhea.
Each item is scored on a 5-point Likert scale, with total scores ranging from 14 to 70.
Higher scores indicate greater functional and emotional impairment associated with dysmenorrhea.
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baseline and after 8 weeks of intervention
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Health-Related Quality of Life
Time Frame: Baseline and Week 8
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Assessed using the 36-Item Short Form Health Survey (SF-36).Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
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Baseline and Week 8
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Menstrual Attitudes
Time Frame: Baseline and Week 8
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The Menstrual Attitude Questionnaire (MAQ) is a self-report questionnaire that assesses attitudes toward menstruation across multiple dimensions.
The questionnaire consists of 33 items rated on a 7-point Likert scale, with total scores ranging from 33 to 231.
Higher scores indicate stronger endorsement of menstrual attitudes represented by the questionnaire.
Because the MAQ includes both positively and negatively worded subscales, higher scores should be interpreted according to the direction of each subscale rather than as uniformly better or worse attitudes.
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Baseline and Week 8
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Collaborators and Investigators
Sponsor
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- YOGA52U
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
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