Investigation of the Effectiveness of Mindfulness-Based Yoga Training in Individuals With Fibromyalgia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in Fibromyalgia Impact
Study Overview
Brief Summary
This randomized controlled trial was conducted between March, 2024 and December 30, 2024 to evaluate the effectiveness of an 8-week Mindfulness-Based Yoga (MBY) program in individuals aged 18 years and older who were diagnosed with fibromyalgia.
Participants who met the eligibility criteria provided written informed consent prior to enrollment. Eligible participants were randomly assigned in a 1:1 ratio to either the MBY intervention group or the active control group using a simple randomization method based on a lottery draw.
The MBY intervention was delivered via telerehabilitation and consisted of structured 75-minute sessions integrating mindfulness practices, breathing exercises, body awareness techniques, and gentle yoga postures. Participants engaged in recorded sessions twice per week and participated in one supervised web-based group session per week led by a trained physiotherapist.
The active control group received standard physiotherapy services provided by the hospital and were instructed to perform regular walking exercises. Both groups received education regarding the treatment process at the beginning of the study.
Assessments were conducted at baseline and at the end of the 8-week intervention period to evaluate clinical and psychosocial outcomes.
This study was registered retrospectively after completion of participant enrollment.
Detailed Description
Methods
The sample of this study consisted of voluntary patients aged 18 years and older who were diagnosed with fibromyalgia and admitted to Avcılar Murat Kölük State Hospital. The study was conducted between march, 2024and December 30, 2024.
Prior to participation, individuals were informed about the purpose and procedures of the study and provided written informed consent. At baseline, demographic and physical characteristics, medication use (type and dosage), and lifestyle characteristics (alcohol and smoking status, and regular physical activity/exercise habits) were recorded.
Based on previous studies and power analysis calculations, the study was planned with a 95% confidence level and 80% statistical power.
Eligible participants were randomly assigned to either the Mindfulness-Based Yoga group or the active control group using a sealed-envelope randomization method.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Due to the nature of the intervention, participants and care providers were not blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Native Turkish speakers who are literate
- •Aged 18 years and older with a confirmed diagnosis of fibromyalgia
- •Stable medical treatment for fibromyalgia for the past 3 months
- •No planned medication changes during the study period
- •Access to a computer, tablet, or smartphone with an active internet connection
- •Able to participate in video conferencing independently or with assistance
- •Voluntarily agree to participate in the study
Exclusion Criteria
- •resence of uncontrolled or clinically significant comorbid conditions (e.g., chronic obstructive pulmonary disease, congestive heart failure, endocrine disorders, neurological or significant psychiatric conditions)
- •Diagnosis of malignancy
- •History of spinal or extremity surgery resulting in functional limitation
- •Participation in another rehabilitation program
- •Any medical or physical condition contraindicating exercise
- •Refusal to participate in the study
Arms & Interventions
Mindfulness-Based Yoga
Participants in this arm received an 8-week telerehabilitation-based Mindfulness-Based Yoga program. The intervention included 75-minute sessions integrating breathing exercises, mindfulness practices, body awareness techniques, and gentle yoga postures. Participants completed two recorded sessions per week and one supervised web-based group session per week led by a trained physiotherapist.
Intervention: Mindfulness-Based Yoga (Behavioral)
Active Control (Conventional Physiotherapy)
Participants in this arm received 10 sessions of conventional physiotherapy provided by the hospital. In addition, they were instructed to perform 20-minute walking exercises three times per week. Participants were monitored and encouraged through phone or message reminders.
Intervention: Conventional Physiotherapy (Other)
Outcomes
Primary Outcomes
Change in Fibromyalgia Impact
Time Frame: Baseline and Week 8
Assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR), a validated self-report instrument measuring functional status, overall impact, and symptom severity in individuals with fibromyalgia. Higher scores indicate greater disease impact.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ebru Durusoy
Msc
Hacettepe University