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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Mindfulness-Based Yoga; Other: Conventional Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34100
      • Avcilar Murat Koluk State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Pregnancy

Participation in another rehabilitation program

Any medical or physical condition contraindicating exercise

Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Names: Experimental: Mindfulness-Based Yoga
Active Comparator: 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.	Other: Conventional Physiotherapy; Ten sessions of conventional physiotherapy combined with prescribed walking exercises performed three times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fibromyalgia Impact	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.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Ebru Durusoy

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Fibromyalgia; telerehabilitation; Mindfulness-Based Yoga
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: HU-FTR-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No