Effects of Progressive Muscle Relaxation and Mindfulness Meditation on Dyspnea, Fatigue and Care Dependency in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in care dependency
研究概览
简要总结
Patients with COPD will be entered. Participants will be randomized to one of three study arms: Arm 1: meditation; Arm 2: relaxation; Arm 3: Control. Hypothesis: Progressive muscle relaxation and mindfulness meditation will decrease severity of dyspnea, fatigue and care dependency.
详细描述
Previous reports have revealed that progressive muscle relaxation and meditation are decreasing symptoms burden in chronic disease. On the other hand, no study has been conducted to determine the effects of progressive relaxation exercise and mindfulness meditation on dyspnea, fatigue and care dependency in patients with COPD. The present study investigates the effects of progressive muscle relaxation and mindfulness meditation in a single-site, 3-arm, assessor-blinded randomized, controlled study of 65 COPD patients. Arm 1: meditation; Arm 2: relaxation; Arm 3: Control.The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease the severity of dyspnea, fatigue and care dependency.
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
- Single (Participant)
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 40 years
- •diagnosed with stage III-IV COPD
- •had at least primary school degree
- •had no cognitive dysfunction, or communication problems
- •were residing in Ankara.
排除标准
- •history of cognitive dysfunction, or communication problems
- •illiteracy
- •applying any complementary and integrative approach during the study
- •participating in a pulmonary rehabilitation program during the study.
结局指标
主要结局
Change in care dependency
时间窗: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Quality of live will be measured by Care Dependency Scale (CDS). The sum of the scores changes from 17 to 85, with higher scores demonstrating lower dependence.
Change in fatigue
时间窗: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Quality of live will be measured by Asthma Fatigue Scale (CAFS). The CAFS scores is standardized to 0-100 in line with the following formula, (100 × (total score-minimum value to be obtained)/range), with higher scores indicating greater fatigue.
Change in dyspnea
时间窗: Baseline measurements, at the end of 12th week and four weeks after the completion of the interventions
Dyspnea will be measured by The Dyspnea-12 Scale. The range of total score was from 0 to 36, with higher scores demonstrating higher dyspnea level.
次要结局
未报告次要终点
研究者
Aylin Helvaci
Research assistant
Hacettepe University