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临床试验/NCT04301700
NCT04301700Unknown不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
65
试验地点
1
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.

研究组 & 干预措施

relaxation

Experimental

The progressive muscle relaxation intervention, designed by Jacobson (1987), will be consist of sessions involving straining and relaxing all muscle groups from head to foot with deep breathing and last for 20 min. The patients will be asked to tense a very muscle group for 5 s and relax after counting up to 10 s while breathing out. In this way, facial, head, neck, shoulders, arms, chest, abdomen, legs, hips, feet and fingers muscles are stretched and relaxed on purpose for relaxing in patients with COPD.

干预措施: mindfullness and relaxation (Behavioral)

mindfulness meditation

Experimental

The research team closely will be following the mindfulness meditation intervention, developed by Kabat-Zinn, Lipworth, and Burney (1985), which is a part of the mindfulness-based stress reduction program. Mindfulness meditation is including interventions such as yoga, body scan, walking meditation, and sitting meditations. In the present study, the researchers will prefer sitting meditation. In this context, the second co-author will want patients to sit up in the chair in an upright and comfortable position. The patients will focus on deep breathing and felled the breath flowing throughout their body during the interventions that will last for 20 min in each session.

干预措施: mindfullness and relaxation (Behavioral)

Control

No Intervention

Patients will continue to receive standard nursing care and no further intervention will be made during the research.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aylin Helvaci

Research assistant

Hacettepe University

研究点 (1)

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