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COPDNCT06933602

Progressive Relaxation for COPD: Effects on Insomnia and Satisfaction

A study testing relaxin in people with COPD and Insomnia, run by Ceylan Aksoy at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
COPD, Insomnia
What is being tested?
relaxin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2025to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • being diagnosed with chronic obstructive pulmonary disease (COPD)

Who cannot join

  • participants must not be under 18 years of age.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ağrı İbrahim Çeçen University

    Ağrı, Ağrı, 04100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Conditions
COPD, Insomnia
Being tested
relaxin
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • relaxinOther

    Progressive Muscle Relaxation (PMR) exercises help alleviate symptoms in patients with COPD by reducing the effects of anxiety and stress, distracting attention from pain, and relieving muscle tension and spasms.

    These exercises are beneficial in managing:

    Tension headaches Back pain Tension and pain in jaw muscles Tension and pain around the eye muscles Muscle spasms Insomnia Stress-related muscle tension The required content of the exercises for relieving stress-related tension will be provided in a booklet. The booklet will be given to the patients following the training session.

Study groups in NCT06933602
Study groupRoleWhat they receive
Intervention GroupExperimentalImplementation of Progressive Muscle Relaxation Training
Receives: Other: relaxin
Control GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital-Related Insomnia Scale:

    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.

    Measured: 7 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start1 Feb 2025
  3. Primary completion22 Aug 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06933602
Sponsor's protocol ID
E-95531838-050.99-116055
Status last verified
Aug 2025
First submitted
11 Apr 2025
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing relaxin in people with COPD and Insomnia, run by Ceylan Aksoy at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital-Related Insomnia Scale: (time frame: 7 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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Clinical Trial NCT06933602 | AzTrials