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).
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
- 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
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.
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Implementation of Progressive Muscle Relaxation Training Receives: Other: relaxin |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted18 Apr 2025
- Study start1 Feb 2025
- Primary completion22 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ceylan Aksoy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ceylan Aksoy, Ataturk University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Progressive Relaxation Exercise Training on Hospital-Acquired Insomnia and Satisfaction Levels in COPD Patients
- ClinicalTrials.gov ID
- NCT06933602
- Acronym / sponsor ID
- E-95531838-050.99-116055
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ceylan AksoyUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 22 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: relaxinImplementation of Progressive Muscle Relaxation Training |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- being diagnosed with chronic obstructive pulmonary disease (COPD)
Key exclusion criteria (1 listed)
- participants must not be under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxinProgressive 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. | Other | Intervention Group |
Primary outcome
Hospital-Related Insomnia Scale:
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.