NCT06933602

Progressive Relaxation for COPD: Effects on Insomnia and Satisfaction

Active, enrolled NA Last updated 24 August 2025

What this trial tests

NA trial testing relaxin in COPD in 70 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 February 2025

Primary endpoint
22 August 2025

30 December 2025

Quick facts

Lead sponsor	Ceylan Aksoy
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	70
Start date	1 February 2025
Primary completion	22 August 2025
Estimated completion	30 December 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• relaxin — full drug profile →

Conditions studied

• COPD — all drugs for COPD →
• Insomnia — all drugs for Insomnia →

Sponsor

Ceylan Aksoy

Who can join

Adults 18 to 85, any sex, with COPD or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.