Effects of Box Breathing Exercise on Sleep Quality, Pain, Gastrointestinal Symptoms, and Comfort in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
研究概览
简要总结
Fibromyalgia is a chronic condition that can cause widespread pain, sleep problems, fatigue, gastrointestinal symptoms, and reduced comfort. This study will evaluate whether box breathing exercise improves sleep quality, pain, gastrointestinal symptoms, and comfort in patients with fibromyalgia.
A total of 60 participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will continue their routine treatment and perform box breathing exercises for 10 minutes twice daily for 30 days. Participants in the control group will continue their routine treatment without receiving the breathing exercise. Sleep quality, pain, gastrointestinal symptoms, and comfort will be assessed at the beginning and at the end of the 30-day study period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Aged 18 years or older
- •Having a diagnosis of fibromyalgia
- •Having a Visual Analog Scale pain score of 5 or higher
- •Having a Pittsburgh Sleep Quality Index score of 5 or higher
- •Being able to communicate and complete the study assessments
- •Voluntarily agreeing to participate and providing informed consent
排除标准
- •Having a respiratory condition such as asthma or chronic obstructive pulmonary disease
- •Having a communication problem that prevents participation in the study procedures or completion of the assessment tools
研究组 & 干预措施
Routine Treatment
Participants in this arm will continue their routine treatment for 30 days and will not receive the box breathing exercise intervention. Outcome assessments will be completed at baseline and at the end of the 30-day study period.
Box Breathing Exercise
Participants in this arm will continue their routine treatment and perform box breathing exercises for 10 minutes twice daily, in the morning and evening, for 30 days. Each breathing cycle consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding the breath again for 4 seconds.
干预措施: Box Breathing Exercise (Behavioral)
结局指标
主要结局
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
时间窗: Baseline and Day 30
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The change in total PSQI score from baseline to the end of the intervention will be evaluated.
次要结局
- Change in Pain Intensity Assessed by the Visual Analog Scale(Baseline and Day 30)
- Change in Comfort Assessed by the General Comfort Scale(Baseline and Day 30)
- Change in Gastrointestinal Symptom Severity Assessed by the Gastrointestinal Symptom Rating Scale(Baseline and Day 30)
研究者
EMRE ERKAL
Assistant Professor
Artvin Coruh University