Investigation of the Effectiveness of Mindfulness-Based Yoga Training in Individuals With Fibromyalgia: A Randomized Controlled Trial
Phase: NA
Conditions: Fibromyalgia
Sponsor: Ebru Durusoy

OFFICIAL STUDY PROTOCOL 
Study Title: Investigation of the Effectiveness of Mindfulness-Based Yoga Training in 
Individuals With 
Fibromyalgia: A Randomized Controlled Trial 
ClinicalTrials.gov Identifier: NCT07439900 
Document Date: 22 September 2023 
Protocol Version: Version 1.2 – Updated for ClinicalTrials.gov posting on 27 February 2026 
Principal Investigator: Ebru Durusoy 
Sponsor: Hacettepe University 
1. Background and Rationale 
Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, 
fatigue, 
sleep disturbances, mood disorders, and psychosocial dysfunction. This randomized 
controlled trial 
was designed to evaluate the effectiveness of mindfulness-based yoga (MBY) training 
delivered via 
telerehabilitation on pain, pain-related problems, fibromyalgia symptoms, kinesiophobia, 
biopsychosocial status, and mindfulness levels. 
2. Ethical Approval 
Ethical approval was granted by the Istanbul Gelisim University Ethics Committee (Decision 
No: 
2023-07-129, dated September 22, 2023). The study was conducted in accordance with the 
Declaration of Helsinki. All participants provided written informed consent prior to 
enrollment. 
3. Study Design 
This study is a parallel-group randomized controlled trial. Participants were randomly 
allocated to 
either the intervention group (MBY via telerehabilitation) or the active control group. 
4. Participants 
Inclusion Criteria: 

- Native Turkish speakers who are literate. 
- Aged 18 years and older with a confirmed diagnosis of fibromyalgia. 
- Stable fibromyalgia medical treatment for at least 3 months. 
- No planned medication changes during the study. 
- Access to a computer/tablet/smartphone with active internet connection. 
- Able to participate in video conferencing or having assistance from a relative. 
- Voluntary agreement to participate. 
Exclusion Criteria: 
- Uncontrolled or clinically significant comorbidities (e.g., COPD, congestive heart failure, 
endocrine 
disorders, neurological or psychiatric disorders). 
- Malignancy. 
- History of spinal or extremity surgery resulting in functional loss. 
- Pregnancy. 
- Participation in another rehabilitation program. 
- Any medical condition preventing safe exercise. 
- Refusal to participate. 
5. Sample Size 
Based on previous studies and power analysis, the study was planned with a 95% confidence 
level 
and 80% statistical power. 
6. Interventions 
Intervention Group: Participants received an 8-week mindfulness-based yoga program 
delivered 
via telerehabilitation. Sessions lasted 60–75 minutes, conducted twice weekly through 
exercise logs 
and once weekly via Zoom-based group sessions under the supervision of a certified 
physiotherapist. 

Active Control Group: Participants received 10 sessions of conventional physiotherapy and 
were 
prescribed 20-minute walking exercises three times per week. Participants were encouraged 
and 
monitored via phone calls or messages. 
Patient Education: At the first treatment session, participants in both groups received 
standardized 
patient education regarding fibromyalgia and the intervention process. 
7. Outcome Measures 
Assessments were performed at baseline and at Week 8. 
Primary and secondary outcomes included: 
- Fibromyalgia symptoms: Fibromyalgia Impact Questionnaire (FIQ) 
- Mindfulness: Mindful Attention Awareness Scale (MAAS) 
- Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS) 
- Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) 
- Fatigue: Fatigue Severity Scale (FSS) 
- Pain-related factors: Pain Catastrophizing Scale (PCS) and Central Sensitization Inventory 
(CSI) 
- Kinesiophobia: Tampa Scale of Kinesiophobia (TSK) 
- Biopsychosocial status: Cognitive Exercise Therapy Approach Scale 
All instruments have validated Turkish versions.