- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07241637
Effect of Tele-Yoga on Pain, Fatigue, and Quality of Life in Endometriosis
The Effect of Tele-Yoga Application on Chronic Pelvic Pain, Fatigue and Quality Of Life In Women With Endometriosis Diagnosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Endometriosis is a chronic, estrogen-dependent condition affecting approximately 10% of women of reproductive age worldwide. In Türkiye, it is estimated that around 2.4 million women are diagnosed with endometriosis. The disease is commonly associated with symptoms such as chronic pelvic pain (CPP), dysmenorrhea, dyspareunia, and infertility, among which CPP is the most prevalent. Endometriosis-related pain is typically recurrent and progressive, significantly impairing women's daily activities and overall quality of life.
Fatigue is another frequently reported symptom among women with endometriosis. Evidence indicates that fatigue is substantially more common in this population compared to the general female population and has a detrimental impact on both physical and psychological well-being. The coexistence of chronic pain and fatigue further exacerbates the negative effects of endometriosis on quality of life.
In recent years, there has been growing interest in Complementary and Integrative Health Approaches (CIHA) for managing pain and fatigue associated with endometriosis. The National Institute for Health and Care Excellence (NICE) guidelines emphasize the importance of multidisciplinary and mind-body-based strategies in endometriosis management. Yoga, recognized by the World Health Organization (WHO) as a complementary health practice, integrates physical postures, breathing exercises, and meditation. It is a low-cost, non-invasive intervention known to promote relaxation and reduce pain, stress, and fatigue.
Telerehabilitation enables the remote delivery of such interventions through digital technologies, improving accessibility and continuity of care. However, there is a limited number of studies investigating telerehabilitation-based yoga interventions among women experiencing chronic pelvic pain due to endometriosis.
Therefore, this project aims to examine the effects of Tele-yoga on chronic pelvic pain, fatigue, and quality of life in women diagnosed with endometriosis. The findings of this research are expected to contribute to developing holistic, accessible, and evidence-based management strategies for women living with endometriosis
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye)
- Ankara University Nursing Faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Voluntary willingness to participate in the study.
- Ability to communicate effectively, with no language barriers.
- Completion of at least primary school education.
- Aged 18 years or older.
- Premenopausal.
- Mild (1-3) or moderate (4-6) chronic pelvic pain.
- Not pregnant.
- No use of any complementary and integrative health practice during the study period.
- No regular exercise (defined as exercising more than three times per week).
- No physiotherapy within the previous 3 months.
- No pelvic surgery within the previous year.
- No planned surgical treatment for endometriosis.
- No other injury or medical condition causing pelvic pain.
- Access to a computer, smartphone, or tablet with a camera and a stable internet connection to participate in the online sessions.
Exclusion Criteria
- Participant's request to withdraw from the study at any stage.
- Failure to attend all tele-yoga sessions.
- Initiation of regular exercise or physiotherapy during the study period.
- Pregnancy during the study period.
- Decision to undergo surgical treatment during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Tele-Yoga Group
The researcher conducted live online tele-yoga sessions with participants diagnosed with endometriosis who had chronic pelvic pain using a computer or tablet.
The intervention consisted of 16 individual sessions delivered twice weekly over eight weeks, with each session lasting 60 minutes.
Sessions were conducted via Google Meet between the researcher and each participant.
The schedule for the following week's sessions was determined after the second session each week.
All sessions were conducted in a private setting chosen by the participant to ensure privacy and comfort, and no screenshots or video recordings were taken.
Each session began with breathing exercises and a 10-minute meditation in the Sukhasana pose, followed by a 10-minute warm-up of stretching and mobilization exercises.
This was followed by a 35-minute yoga sequence integrating various asanas with breathing techniques and concluded with 5 minutes of deep relaxation in the Savasana pose.
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Tele-yoga is a telerehabilitation method that enables the delivery of yoga-based rehabilitation services through electronic systems.
Initially developed for emergency management, this approach has become effective in daily practice with the increasing cost of treatment and the privatization of healthcare services.
Yoga is a practice that can be adapted to the individual needs of each woman.
In women with endometriosis, yoga helps develop a different response to pain through mindful attention to painful areas, relaxation postures, breathing techniques, and movement sequences
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No Intervention: Control Group
No intervention was applied to the control group.
Participants were followed for eight weeks and completed the study scales at the end of the eighth week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Rating Scale (NRS)
Time Frame: The scale was administered to all groups before the intervention began and after the intervention was completed (at the end of the eighth week).
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In patients diagnosed with endometriosis, the Numerical Rating Scale (NRS) is used to assess pain intensity by having the patient rate their perceived pain on a scale from 0 to 10.A value of 0 is considered "no pain," while a value of 10 is considered "the worst pain imaginable."
Patients are asked to circle the number representing the amount of pain they experience during the assessment.
As the number on the scale increases, the pain increases.
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The scale was administered to all groups before the intervention began and after the intervention was completed (at the end of the eighth week).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Fatigue Severity Scale (FSS)
Time Frame: The scale was administered to all groups before the intervention and after the intervention was completed (at the end of the eighth week).
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The Fatigue Severity Scale (FSS) is used to determine how fatigued the patient has felt over the past week, including the day the test is administered.
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The scale was administered to all groups before the intervention and after the intervention was completed (at the end of the eighth week).
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The Endometriosis Health Profile-5 (EHP-5)
Time Frame: The scale was administered to all groups before the intervention began and after the intervention was completed (at the end of the eighth week).
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The Endometriosis Health Profile-5 (EHP-5) is used to assess the impact of endometriosis on women's quality of life.
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The scale was administered to all groups before the intervention began and after the intervention was completed (at the end of the eighth week).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Funda Özdemir, Ankara University
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraU-HEM-RK-02
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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