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临床试验/NCT06933602
NCT06933602进行中(未招募)不适用

The Impact of Progressive Relaxation Exercise Training on Hospital-Acquired Insomnia and Satisfaction Levels in COPD Patients

Ceylan Aksoy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
70
试验地点
1
主要终点
Hospital-Related Insomnia Scale:

研究概览

简要总结

In the life model based on the activities of living developed by nursing theorists Roper, Logan, and Tierney, sleep is identified as one of the twelve essential activities. Sleep is a fundamental need initiated by the circadian rhythm and sleep/wake homeostatic pressure, and it is followed by a period of wakefulness. Therefore, early identification of sleep disorders and the improvement of sleep and quality of life should be primary goals. As sleep quality improves, individuals feel better both physically and mentally; however, in individuals with Chronic Obstructive Pulmonary Disease (COPD), sleep problems tend to increase as symptoms worsen.

Non-pharmacological methods such as breathing exercises, reflexology, relaxation exercises, and physical exercises are commonly used to cope with symptoms in individuals with COPD. Among these, progressive muscle relaxation exercises (PMRE) have recently become an important component in the care of individuals with chronic illnesses, due to their benefits in reducing anxiety and stress, diverting attention from pain, and alleviating muscle tension and contractions.

Patient education, which is a component of the nurse's role as an educator, aims to help the patient prevent complications, gain self-sufficiency in daily life, cope with illnesses, adapt to the disease, and improve decision-making abilities. In addition to these numerous benefits, patient education also contributes to increased patient satisfaction. Progressive muscle relaxation training, by increasing body awareness-such as recognizing which muscles are located in which areas and how they react under stress-is considered an important educational tool that can enhance the patient's adaptation to the illness and assist in coping with symptoms.

The study will be conducted as a randomized controlled trial with a pretest-posttest experimental design. The sample will consist of a total of 70 patients-35 in the experimental group and 35 in the control group-who have been diagnosed with COPD at the Department of Chest Diseases in Van Yüzüncü Yıl University Dursun Odabaş Medical Center, meet the research criteria, and agree to participate in the study.

To ensure randomization, a dice-rolling method will be used. Each patient meeting the inclusion criteria will roll a die: if an odd number appears on the upper face, the patient will be assigned to the control group; if an even number, to the experimental group.

Both the experimental and control groups will be administered the Patient Information Form and the Insomnia Severity Index for Hospitalized Patients as pretests. In addition, the Patient Satisfaction with Education Scale will be applied as a posttest only to the experimental group.

While patients in the experimental group will be provided with an educational booklet and receive progressive muscle relaxation training, patients in the control group will receive routine nursing care and standard treatment without any additional training.

One week later, both groups will again be administered the Patient Information Form and the Insomnia Severity Index for Hospitalized Patients as posttests.

Data obtained from the study will be analyzed using the SPSS (Statistical Package for the Social Sciences) version 23.0 software.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •being diagnosed with chronic obstructive pulmonary disease (COPD)

排除标准

  • •participants must not be under 18 years of age.

研究组 & 干预措施

Control Group

No Intervention

Intervention Group

Experimental

Implementation of Progressive Muscle Relaxation Training

干预措施: relaxin (Other)

结局指标

主要结局

Hospital-Related Insomnia Scale:

时间窗: 7 day

The Hospital-Related Insomnia Scale was developed by Çiftçi, Yıldız, and Yıldız (2023) to assess patients' levels of insomnia caused by hospital-related factors. The scale consists of 18 items and five subdimensions: physical environmental factors (items 1-5), psychological factors (items 6-9), safety factors (items 10-12), socio-economic factors (items 13-15), and nutritional factors (items 16-18). The Cronbach's alpha reliability coefficients for the subdimensions were 0.842, 0.804, 0.786, 0.677, and 0.672 respectively, while the overall internal consistency of the scale was found to be 0.783. The scale is evaluated by calculating the average score of the items, with scores ranging from 1 to 5. Higher scores indicate greater levels of hospital-related insomnia associated with the corresponding factor.

次要结局

未报告次要终点

研究者

发起方
Ceylan Aksoy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ceylan Aksoy

LECTURER

Ataturk University

研究点 (1)

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