Occupational StressNCT05056571
Progressive Muscle Relaxation Exercise on Intensive Care Nurses
A study testing Progressive muscle relaxation in people with Occupational Stress, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Nurses who intensive care unit will be entered. Participants will be randomized to one of two study arms: Arm 1: Progressive muscle relaxation; Arm 2: control. Hypothesis: Progressive muscle relaxation will decrease occupational stress, headache and improve well-being. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress
- What is being tested?
- Progressive muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Sep 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working in cardiovascular intensive care for at least 6 months
- Having a headache at least once a week
- No physical disability
- Those who do not have a neurological diagnosis (having cerebrovascular disease, multiple sclerosis, etc.)
- No psychiatric diagnosis
- Not applying any complementary methods at the time the research was conducted.
- Nurses who volunteered to participate in the study
Who cannot join
- Nurses followed up with the diagnosis of end-stage renal disease, Chronic Obstructive Pulmonary Disease, advanced heart failure, chronic liver disease, musculoskeletal problem, hypothyroidism and depression
- Having physical and mental health problems that prevent communication
- Nurses who practiced any complementary method (relaxation exercise, yoga, etc.) during the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital Cardiovascular Hospital
Ankara, Cankaya, 06800
Bülent Güngörer, Dr., +09 312 552 60 00, ankarasehir@saglik.gov.tr
Zehra G Metin, PhD
About this study
Official title: The Effects of Online Progressive Muscle Relaxation Exercise on Occupational Stress, Headache and Well-being in Intensive Care Nurses
Nurses who intensive care unit will be entered. Participants will be randomized to one of two study arms:
Arm 1: Progressive muscle relaxation; Arm 2: control. Hypothesis: Progressive muscle relaxation will decrease occupational stress, headache and improve well-being.
Read the detailed description
Previous reports have revealed that non-pharmacological approaches such as aromatherapy, massage, meditation, music therapy, breathing exercises, yoga and progressive muscle relaxation exercises (PGE) have been used to reduce stress and fatigue of individuals and improve their well-being.
However, there have been limited studies that directly focus on supporting intensive care nurses who face serious problems with intense work tempo, experience excessive stress, headache, tension, fatigue, are open to psychosocial problems such as anxiety, depression and burnout.
Besides, till date, no study has been conducted to determine the effects of progressive relaxation exercise on occupational stress, headache and well-being for intensive care nurses.
The present study investigates the effects of progressive muscle relaxation in a single-site, 2-arm, assessor-blinded randomized, controlled study of 100 intensive care nurses.
Arm 1: relaxation; Arm 2: Attention matched control. The investigators hypothesize that progressive muscle relaxation will decrease the severity of occupational stress and headache and improve well-being.
- Conditions
- Occupational Stress
- Being tested
- Progressive muscle relaxation
- Keywords
- headache, intensive care units, occupational Stress, relaxation, well-being
- Medical subject headings
- Occupational Stress, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxationBehavioural
Progressive muscle relaxation exercise is a type of exercise in which tense muscles in your body gradually relax and relax. It is an application that allows you to forcefully stretch every muscle group in your body, hold it tight for 5 seconds, and then relax it. Visualize your tense muscles throughout this exercise and imagine that the feeling of relaxation spreads to all your muscles in the form of a wave and the tension is relieved. Keep breathing throughout the entire exercise.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation exercise | Experimental | Intensive care nurses will apply 20 minutes of online (zoom meeting) progressive muscle relaxation exercise twice a week, for 8 weeks, for a total of 16 group sessions. In order to support nurses' adaptation to the research, the group counselor will remind the nurses by phone twice a week during the implementation process, and their regular participation in online sessions will be supported. Receives: Behavioral: Progressive muscle relaxation |
| Control | No intervention | No attempt will be made during the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Occupational Stress
Occupational stress severity will be measured based on patient report by the Occupational Stress Scale.
Higher scores indicate increased occupational stress.
Measured: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Secondary outcomes (2)
Change in headache severity
Headache severity will be measured based on patient report by the Visual Analog Scale. Lower scores indicate low level of headache.
Measured: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Change in Well-being
Well-being will be measured by the Flourishing Scale. Higher scores on the scale mean better well-being.
Measured: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Merve Gulbahar, Hacettepe University
- Investigators
- Zehra G Metin, PhD, Principal investigator, Hacettepe University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056571
- Sponsor's protocol ID
- E2-21-814
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Online Progressive Muscle Relaxation Exercise on Occupational Stress, Headache and Well-being in Intensive Care Nurses
- ClinicalTrials.gov ID
- NCT05056571
- Acronym / sponsor ID
- E2-21-814
- Conditions
- Occupational Stress
- Keywords
- headache, intensive care units, occupational Stress, relaxation, well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 24 Sep 2021 (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.
Nurses who intensive care unit will be entered. Participants will be randomized to one of two study arms:
Arm 1: Progressive muscle relaxation; Arm 2: control. Hypothesis: Progressive muscle relaxation will decrease occupational stress, headache and improve well-being.
Detailed description
Previous reports have revealed that non-pharmacological approaches such as aromatherapy, massage, meditation, music therapy, breathing exercises, yoga and progressive muscle relaxation exercises (PGE) have been used to reduce stress and fatigue of individuals and improve their well-being.
However, there have been limited studies that directly focus on supporting intensive care nurses who face serious problems with intense work tempo, experience excessive stress, headache, tension, fatigue, are open to psychosocial problems such as anxiety, depression and burnout.
Besides, till date, no study has been conducted to determine the effects of progressive relaxation exercise on occupational stress, headache and well-being for intensive care nurses.
The present study investigates the effects of progressive muscle relaxation in a single-site, 2-arm, assessor-blinded randomized, controlled study of 100 intensive care nurses.
Arm 1: relaxation; Arm 2: Attention matched control. The investigators hypothesize that progressive muscle relaxation will decrease the severity of occupational stress and headache and improve well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation exercise | Experimental | Behavioral: Progressive muscle relaxationIntensive care nurses will apply 20 minutes of online (zoom meeting) progressive muscle relaxation exercise twice a week, for 8 weeks, for a total of 16 group sessions. In order to support nurses' adaptation to the research, the group counselor will remind the nurses by phone twice a week during the implementation process, and their regular participation in online sessions will be supported. |
| Control | No intervention | –No attempt will be made during the research. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Working in cardiovascular intensive care for at least 6 months
- Having a headache at least once a week
- No physical disability
- Those who do not have a neurological diagnosis (having cerebrovascular disease, multiple sclerosis, etc.)
- No psychiatric diagnosis
Key exclusion criteria (3 listed)
- Nurses followed up with the diagnosis of end-stage renal disease, Chronic Obstructive Pulmonary Disease, advanced heart failure, chronic liver disease, musculoskeletal problem, hypothyroidism and depression
- Having physical and mental health problems that prevent communication
- Nurses who practiced any complementary method (relaxation exercise, yoga, etc.) during 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 muscle relaxationProgressive muscle relaxation exercise is a type of exercise in which tense muscles in your body gradually relax and relax. It is an application that allows you to forcefully stretch every muscle group in your body, hold it tight for 5 seconds, and then relax it. Visualize your tense muscles throughout this exercise and imagine that the feeling of relaxation spreads to all your muscles in the form of a wave and the tension is relieved. Keep breathing throughout the entire exercise. | Behavioural | Relaxation exercise |
Primary outcome
Change in Occupational Stress
Time frame: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Occupational stress severity will be measured based on patient report by the Occupational Stress Scale. Higher scores indicate increased occupational stress.
2 secondary outcomes
Change in headache severity
Time frame: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Change in Well-being
Time frame: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- 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.
Zehra G Metin, PhD principal investigator
Hacettepe University Faculty of Nursing
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 muscle relaxation in people with Occupational Stress, run by Hacettepe 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bulent Güngörer, Dr. (+09 312 552 60 00, ankarasehir@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Occupational Stress (time frame: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions). 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 Sep 2021.