Progressive Muscle Relaxation ExerciseNCT06859983
The Effect of Progressive Muscle Relaxation Exercises on Fatigue Severity and Sleep Quality in Emergency Department Nurses
A study testing progressive relaxation exercise in people with Progressive Muscle Relaxation Exercise, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Emergency departments are critical units where patients with life-threatening conditions and acute illnesses receive rapid interventions. Nurses working in these units aim to provide the best possible healthcare by intervening with patients at high risk of life-threatening situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Muscle Relaxation Exercise
- What is being tested?
- progressive relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Working in the emergency service unit,
- No psychiatric disorder,
- Can do progressive relaxation exercises,
- Apply progressive relaxation exercises for one month,
- No disease that prevents progressive relaxation exercise,
Who cannot join
- Nurses who do not meet the inclusion criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Muscle Relaxation Exercises on Fatigue Severity and Sleep Quality in Emergency Department Nurses: A Self-Controlled Quasi-Experimental Study
Emergency departments are critical units where patients with life-threatening conditions and acute illnesses receive rapid interventions. Nurses working in these units aim to provide the best possible healthcare by intervening with patients at high risk of life-threatening situations. However, long working hours, inadequate working conditions, high stress, and critical patient care often lead to physiological issues among nurses. Fatigue and insomnia, which are commonly linked to burnout, are among the most frequent physiological problems.
Insomnia is a condition characterized by poor and irregular sleep patterns occurring within a 24-hour period due to disruption of the circadian rhythm. Chronic insomnia, if persistent, triggers fatigue. Fatigue is a subjective condition that, when prolonged, negatively affects nurses' daily activities and reduces job performance. Moreover, increasing fatigue has significant adverse effects on alertness, attention, judgment, and mood. These effects can lead to accidents, errors in practice, and injuries.
Read the detailed description
Progressive relaxation exercises reduce blood levels of epinephrine and norepinephrine, oxygen consumption, blood pressure, metabolic rate, heart rate, muscle tension, lactic acid levels, pain and fatigue. On the other hand, concentration increases endorphin release, reduces insomnia and provides mental well-being. When the literature was examined, progressive relaxation exercise practices were performed on patients with rheumatoid arthritis and it was determined that there were positive effects on insomnia and fatigue levels in patients at the end of a six-week period. In another study evaluating the effectiveness of progressive relaxation exercise in dialysis patients, it was found that the fatigue level of the patients decreased. Again, when the literature was examined, two studies evaluating the effectiveness of progressive relaxation exercise on intensive care nurses were found in our country. In these studies conducted with intensive care nurses, it was reported that progressive relaxation exercises had a positive effect on fatigue.
In line with our research, no study was found to examine the effect of progressive relaxation exercises applied to nurses working in the emergency department on fatigue severity and sleep quality.
Translated with www.DeepL.com/Translator (free version)
- Conditions
- Progressive Muscle Relaxation Exercise
- Being tested
- progressive relaxation exercise
- Keywords
- Progressive muscle relaxation exercise, Emergency department, nurse, fatigue severity, sleep quality
- Medical subject headings
- Emergencies, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseBehavioural
he researcher will provide approximately 45 minutes of information about relaxation exercises to the nurses. During the application of progressive relaxation exercises, the necessary precautions to be taken during and after the exercise will be explained to the nurses. In the study, a sound recording that includes the PRE will be uploaded to each nurse's phone. The relaxation exercises CD created by the Turkish Psychologists Association will be used for the sound recording. The first section of the CD, which is 10 minutes long, defines deep relaxation, its purpose, and the precautions to be taken during the exercise. The second 30-minute section explains the relaxation exercises with the sound of a stream and verbal instructions. The third 30-minute section contains only relaxation music without any verbal instructions. After the training, nurses will be given the sound recording in CD form. Nurses will be asked to perform the PRE according to the instructions. They will be instructed
| Study group | Role | What they receive |
|---|---|---|
| Emergency department nurses | Experimental | In the first phase, data collection will begin on the first day (n=35) with nurses, and the nurse introductory information form will be collected through face-to-face interviews. Then, at the end of each week during the 4-week period, nurses will complete the "Fatigue Severity Scale" and the "Pittsburgh Sleep Quality Index (PSQI)" four times. This will complete the pre-intervention evaluation. Receives: Behavioral: progressive relaxation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurse Introductory Information Form
The data collection form consists of 12 statements developed by the researchers as a result of the literature review, questioning age, gender, educational status, marital status, working time in the profession, working style, sleep quality and fatigue.
Measured: he necessary evaluation will be made at the end of the first week.
Fatigue Severity Scale
The scale developed by Krup (1989) consists of nine items assessing the general effect of fatigue on daily activities. The Turkish validity and reliability of the scale was performed by Armutlu et al. In the scale, individuals are asked to rate the fatigue they felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree) (add 2 to 6). The total score is calculated by averaging the nine items. The cut-off value for pathological fatigue is set at 4 and above. The lower the total score, the lower the fatigue. Cronbach's alpha coefficient of the scale was 0.94 in the study of Armutlu et al.
Measured: The necessary evaluation will be made at the end of the first week.
Pittsburgh Sleep Quality Index
expressed in a single item, while others are expressed in a group of several items. Each item score ranges from "0" to "3". The total PDQI score is between 0 and 21. A score above 5 indicates that the sleep quality of the individual is poor. The Cronbach alpha value of the scale was found to be 0.80 in the study of Ağargün et al.
Measured: The necessary evaluation will be made at the end of the first week.
Secondary outcomes (3)
Nurse Introductory Information Form
The data collection form consists of 12 statements developed by the researchers as a result of the literature review, questioning age, gender, educational status, marital status, working time in the profession, working style, sleep quality and fatigue.
Measured: The necessary evaluation will be made at the end of the first week.
Fatigue Severity Scale
The scale developed by Krup (1989) consists of nine items assessing the general effect of fatigue on daily activities. The Turkish validity and reliability of the scale was performed by Armutlu et al. In the scale, individuals are asked to rate the fatigue they felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree) (add 2 to 6). The total score is calculated by averaging the nine items. The cut-off value for pathological fatigue is set at 4 and above. The lower the total score, the lower the fatigue. Cronbach's alpha coefficient of the scale was 0.94 in the study of Armutlu et al.
Measured: The necessary evaluation will be made at the end of the second week.
Pittsburgh Sleep Quality Index
The scale developed by Krup (1989) consists of nine items assessing the general effect of fatigue on daily activities. The Turkish validity and reliability of the scale was performed by Armutlu et al. In the scale, individuals are asked to rate the fatigue they felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree) (add 2 to 6). The total score is calculated by averaging the nine items. The cut-off value for pathological fatigue is set at 4 and above. The lower the total score, the lower the fatigue. Cronbach's alpha coefficient of the scale was 0.94 in the study of Armutlu et al.
Measured: The necessary evaluation will be made at the end of the second week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Mar 2025
- Primary completion8 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Muscle Relaxation ExerciseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyye Akcoban, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859983
- Sponsor's protocol ID
- HMKU-KMY-SA-04
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 2 May 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises on Fatigue Severity and Sleep Quality in Emergency Department Nurses: A Self-Controlled Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT06859983
- Acronym / sponsor ID
- HMKU-KMY-SA-04
- Conditions
- Progressive Muscle Relaxation Exercise
- Keywords
- Progressive muscle relaxation exercise, Emergency department, nurse, fatigue severity, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Mar 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.
Emergency departments are critical units where patients with life-threatening conditions and acute illnesses receive rapid interventions. Nurses working in these units aim to provide the best possible healthcare by intervening with patients at high risk of life-threatening situations. However, long working hours, inadequate working conditions, high stress, and critical patient care often lead to physiological issues among nurses. Fatigue and insomnia, which are commonly linked to burnout, are among the most frequent physiological problems.
Insomnia is a condition characterized by poor and irregular sleep patterns occurring within a 24-hour period due to disruption of the circadian rhythm. Chronic insomnia, if persistent, triggers fatigue. Fatigue is a subjective condition that, when prolonged, negatively affects nurses' daily activities and reduces job performance. Moreover, increasing fatigue has significant adverse effects on alertness, attention, judgment, and mood. These effects can lead to accidents, errors in practice, and injuries.
Detailed description
Progressive relaxation exercises reduce blood levels of epinephrine and norepinephrine, oxygen consumption, blood pressure, metabolic rate, heart rate, muscle tension, lactic acid levels, pain and fatigue. On the other hand, concentration increases endorphin release, reduces insomnia and provides mental well-being. When the literature was examined, progressive relaxation exercise practices were performed on patients with rheumatoid arthritis and it was determined that there were positive effects on insomnia and fatigue levels in patients at the end of a six-week period. In another study evaluating the effectiveness of progressive relaxation exercise in dialysis patients, it was found that the fatigue level of the patients decreased. Again, when the literature was examined, two studies evaluating the effectiveness of progressive relaxation exercise on intensive care nurses were found in our country. In these studies conducted with intensive care nurses, it was reported that progressive relaxation exercises had a positive effect on fatigue.
In line with our research, no study was found to examine the effect of progressive relaxation exercises applied to nurses working in the emergency department on fatigue severity and sleep quality.
Translated with www.DeepL.com/Translator (free version)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency department nurses | Experimental | Behavioral: progressive relaxation exerciseIn the first phase, data collection will begin on the first day (n=35) with nurses, and the nurse introductory information form will be collected through face-to-face interviews. Then, at the end of each week during the 4-week period, nurses will complete the "Fatigue Severity Scale" and the "Pittsburgh Sleep Quality Index (PSQI)" four times. This will complete the pre-intervention evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Working in the emergency service unit,
- No psychiatric disorder,
- Can do progressive relaxation exercises,
- Apply progressive relaxation exercises for one month,
- No disease that prevents progressive relaxation exercise,
Key exclusion criteria (1 listed)
- Nurses who do not meet the inclusion criteria will be excluded from the study.
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 |
|---|---|---|
| progressive relaxation exercisehe researcher will provide approximately 45 minutes of information about relaxation exercises to the nurses. During the application of progressive relaxation exercises, the necessary precautions to be taken during and after the exercise will be explained to the nurses. In the study, a sound recording that includes the PRE will be uploaded to each nurse's phone. The relaxation exercises CD created by the Turkish Psychologists Association will be used for the sound recording. The first section of the CD, which is 10 minutes long, defines deep relaxation, its purpose, and the precautions to be taken during the exercise. The second 30-minute section explains the relaxation exercises with the sound of a stream and verbal instructions. The third 30-minute section contains only relaxation music without any verbal instructions. After the training, nurses will be given the sound recording in CD form. Nurses will be asked to perform the PRE according to the instructions. They will be instructed | Behavioural | Emergency department nurses |
Primary outcome
Nurse Introductory Information Form
Time frame: he necessary evaluation will be made at the end of the first week.
The data collection form consists of 12 statements developed by the researchers as a result of the literature review, questioning age, gender, educational status, marital status, working time in the profession, working style, sleep quality and fatigue.
Fatigue Severity Scale
Time frame: The necessary evaluation will be made at the end of the first week.
The scale developed by Krup (1989) consists of nine items assessing the general effect of fatigue on daily activities. The Turkish validity and reliability of the scale was performed by Armutlu et al. In the scale, individuals are asked to rate the fatigue they felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree) (add 2 to 6). The total score is calculated by averaging the nine items. The cut-off value for pathological fatigue is set at 4 and above. The lower the total score, the lower the fatigue. Cronbach's alpha coefficient of the scale was 0.94 in the study of Armutlu et al.
Pittsburgh Sleep Quality Index
Time frame: The necessary evaluation will be made at the end of the first week.
expressed in a single item, while others are expressed in a group of several items. Each item score ranges from "0" to "3". The total PDQI score is between 0 and 21. A score above 5 indicates that the sleep quality of the individual is poor. The Cronbach alpha value of the scale was found to be 0.80 in the study of Ağargün et al.
3 secondary outcomes
Nurse Introductory Information Form
Time frame: The necessary evaluation will be made at the end of the first week.
Fatigue Severity Scale
Time frame: The necessary evaluation will be made at the end of the second week.
Pittsburgh Sleep Quality Index
Time frame: The necessary evaluation will be made at the end of the second week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 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 progressive relaxation exercise in people with Progressive Muscle Relaxation Exercise, run by Mustafa Kemal University 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 5 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: finished, as of the sponsor's last update on 2 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nurse Introductory Information Form (time frame: he necessary evaluation will be made at the end of the first week.). The study lists 3 primary outcomes in all. 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 2 May 2025.