- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056571
Progressive Muscle Relaxation Exercise on Intensive Care Nurses
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bülent Güngörer, Dr.
- Phone Number: +09 312 552 60 00
- Email: ankarasehir@saglik.gov.tr
Study Locations
-
-
Cankaya
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Ankara, Cankaya, Turkey, 06800
- Recruiting
- Ankara City Hospital Cardiovascular Hospital
-
Contact:
- Bülent Güngörer, Dr.
- Phone Number: +09 312 552 60 00
- Email: ankarasehir@saglik.gov.tr
-
Principal Investigator:
- Zehra G Metin, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Relaxation exercise
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.
|
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.
|
No Intervention: Control
No attempt will be made during the research.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in headache severity
Time Frame: Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
|
Headache severity will be measured based on patient report by the Visual Analog Scale.
Lower scores indicate low level of headache.
|
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
|
Well-being will be measured by the Flourishing Scale.
Higher scores on the scale mean better well-being.
|
Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zehra G Metin, PhD, Hacettepe University Faculty of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-21-814
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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