Investigation of the Effectiveness of Mindfulness-Based Yoga Training in Individuals With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Fibromyalgia Impact
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the intervention, participants and care providers were not blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Change in Fibromyalgia Impact
时间窗: 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.
次要结局
未报告次要终点
研究者
Ebru Durusoy
Msc
Hacettepe University