NCT07439900

Mindfulness-Based Yoga for Individuals With Fibromyalgia: A RCT

Investigation of the Effectiveness of Mindfulness-Based Yoga Training in Individuals With Fibromyalgia: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Ebru Durusoy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. The Mindfulness-Based Yoga group received an 8-week telerehabilitation-based Mindfulness-Based Yoga program. Each session lasted 75 minutes. Participants completed recorded exercise sessions twice per week and attended one supervised web-based group session per week conducted by a trained physiotherapist. The active control group received 10 sessions of conventional physiotherapy provided by the hospital and were additionally instructed to perform 20-minute walking exercises three times per week. Participants were encouraged and monitored via telephone calls or text messages. All interventions were delivered by a physiotherapist trained in the relevant field. At the first treatment session, both groups received education regarding the treatment process and exercises, as well as disease-related information. Participants were evaluated twice: at baseline and at the end of the 8-week intervention period. Outcome measures included fibromyalgia symptoms (Revised Fibromyalgia Impact Questionnaire - FIQR), mindfulness level (Mindful Attention Awareness Scale - MAAS), emotional status (Hospital Anxiety and Depression Scale - HADS), fatigue (Fatigue Severity Scale - FSS), pain-related factors (Pain Catastrophizing Scale - PCS; Central Sensitization Inventory - CSI), fear-avoidance beliefs (Tampa Scale of Kinesiophobia - TSK), and biopsychosocial status (Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire - BETY-BQ). All measurement tools used in the study have validated Turkish versions. IInclusion Criteria (Summary Version) Participants were eligible for inclusion if they were native Turkish speakers aged 18 and older with a confirmed diagnosis of fibromyalgia, had stable medical treatment for the past three months with no planned medication changes during the study period, had access to a computer, tablet, or smartphone with an active internet connection, were able to participate in video conferencing (independently or with assistance), and voluntarily agreed to participate in the study. Exclusion Criteria Participants were excluded if they: Had uncontrolled or clinically significant comorbid conditions (e.g., chronic obstructive pulmonary disease, congestive heart failure, endocrine disorders, neurological or severe psychiatric conditions) Had a diagnosis of malignancy Had a history of spinal or extremity surgery resulting in functional limitation Were pregnant Were participating in another rehabilitation program Had any contraindication to exercise Declined participation Statistical Analysis Statistical analyses were performed using IBM SPSS Statistics version 25. Descriptive statistics were presented as minimum, maximum, and mean ± standard deviation (X±SD) for continuous variables, and frequency (n) and percentage (%) for categorical variables. Normality of distribution was assessed using the Shapiro-Wilk test. If data were normally distributed, within-group comparisons were analyzed using the paired t-test and between-group comparisons using the independent t-test. If data were not normally distributed, the Wilcoxon signed-rank test was used for within-group comparisons and the Mann-Whitney U test for between-group comparisons.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Yoga	An 8-week telerehabilitation-based mindfulness yoga program including breathing exercises, body awareness, and gentle yoga postures delivered by a trained physiotherapist.
OTHER	Conventional Physiotherapy	Ten sessions of conventional physiotherapy combined with prescribed walking exercises performed three times per week.

Timeline

• Start date: 2024-03-14
• Primary completion: 2024-12-30
• Completion: 2026-03-30
• First posted: 2026-02-27
• Last updated: 2026-03-04

Locations

1 site across 1 country: Turkey (Türkiye)