- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435664
The Effect of Progressive Relaxation Exercise on Fatigue in Intensive Care Nurses
January 11, 2024 updated by: Selva Ezgi Askar, Mustafa Kemal University
This study was planned as a randomized controlled experiment.
It was aimed to examine the effect of progressive relaxation exercises applied to intensive care nurses on fatigue.
The sociodemographic information of the participants will be collected with the 'Personal Information Form' and their fatigue levels with the 'Fatigue Severity Scale'.
SPSS 22.0 package program will be used in the analysis of the data.
p<0.05 will be considered significant.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Intensive care nurses experience high levels of fatigue due to the physically and mentally demanding tasks they undertake.
For example; Conditions such as prolonged seizures, difficulty sleeping, and heavy workload trigger this fatigue.
One of the non-pharmacological interventions used in the management of fatigue experienced by intensive care nurses is progressive relaxation exercise (PGE).
PGE involves voluntary, continuous and systematic stretching and subsequent relaxation of various muscle groups and was first described by Jacobson in 1938.
The purpose of PGE is to focus attention on skeletal muscles and relax the whole body.
While doing the exercise, the individual feels the difference between tension and relaxation in the muscles.
Thus, when needed, it learns to relax in order to reduce the tension in the muscles.
In the literature, it has been shown that PGE reduces the severity of fatigue caused by different chronic diseases.
In this context, in this study, it is aimed to examine the effect of progressive relaxation exercise applied to intensive care nurses on fatigue and to contribute to the literature and to the fatigue management of nurses in line with the results obtained.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hatay, Turkey, 31080
- Hatay Mustafa Kemal University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Working for at least 6 months
- Having a Fatigue Severity Scale score of 2.8 and above
- Volunteer to participate in research
Exclusion Criteria:
- Having a problem that prevents breathing through the nose
- Having a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma
- Being pregnant
- Having physical and mental health problems that prevent communication
- Practicing any complementary method (relaxation exercise, yoga, etc.) during the study
- Informed about the research but willing to participate in the research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
During the first interview, the nurses in the intervention group were informed about PGE in a convenient and quiet room within the hospital, face-to-face and face-to-face.
Afterwards, the researcher 15 minutes of application was made with the accompaniment.
In order for the participants to practice at home, a voice recording containing the PGE steps voiced by the researcher in his own voice was sent to the nurses' phones.
Nurses were asked to perform the PGE exercise by listening to the audio recording file for 15 minutes once a day for 4 weeks.
In addition, daily reminders were made by creating a group over the WhatsApp application in order to prevent it from being forgotten.
They were asked to provide feedback on their compliance with the program.
At the beginning of the study, at the beginning of the study, at the 1st, 2nd, 3rd and 4th weeks (at the end of the application), the 'Fatigue Severity Scale' was administered again through face-to-face interviews.
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It consists of sessions involving deep breathing and stretching and relaxing the body.
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No Intervention: Control group
No intervention was made to the nurses in the control group.
In the second and fourth weeks of the study, the "Fatigue Severity Scale" will be applied again through face-to-face interviews.
At the end of the study, nurses will be informed about PGE and a voice recording will be sent to their phones from the WhatsApp application, containing the PGE steps, which the researcher voiced with her voice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in fatigue
Time Frame: At the beginning of the study, at weeks 1, 2, 3 and 4
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It was measured with the Fatigue Severity Scale.
The fatigue severity scale is a short measurement tool consisting of nine questions developed by Krupp and used to measure the degree of fatigue in patients with multiple sclerosis.
The validity and reliability of the scale Armutlu et al. and Cronbach's alpha coefficient was found to be 0.94.
In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree).
The total score is calculated by taking the average of nine items.
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At the beginning of the study, at weeks 1, 2, 3 and 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mander J, Blanck P, Neubauer AB, Kroger P, Fluckiger C, Lutz W, Barnow S, Bents H, Heidenreich T. Mindfulness and progressive muscle relaxation as standardized session-introduction in individual therapy: A randomized controlled trial. J Clin Psychol. 2019 Jan;75(1):21-45. doi: 10.1002/jclp.22695. Epub 2018 Oct 8.
- Alkan Y. Ş, Akansel N (2021). Yoğun Bakım Hemşirelerinde Yorgunluk ile İlgili Çalışmaların İncelenmesi. Hacettepe Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 8(2), 249 - 271. Doi: 10.21020/husbfd.804308
- Gok Metin Z, Karadas C, Izgu N, Ozdemir L, Demirci U. Effects of progressive muscle relaxation and mindfulness meditation on fatigue, coping styles, and quality of life in early breast cancer patients: An assessor blinded, three-arm, randomized controlled trial. Eur J Oncol Nurs. 2019 Oct;42:116-125. doi: 10.1016/j.ejon.2019.09.003. Epub 2019 Sep 6.
- Kapucu S. Yılmaz Kütmeç C. (2018). Kronik hastalıklarda progresif gevşeme egzersizlerinin yararı. F.Ü.Sağ.Bil.Tıp.Derg. 32 (2), 111-114. http://www.fusabil.org
- Park ES, Yim HW, Lee KS. Progressive muscle relaxation therapy to relieve dental anxiety: a randomized controlled trial. Eur J Oral Sci. 2019 Feb;127(1):45-51. doi: 10.1111/eos.12585. Epub 2018 Nov 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
April 29, 2022
Study Completion (Actual)
April 29, 2022
Study Registration Dates
First Submitted
June 23, 2022
First Submitted That Met QC Criteria
June 23, 2022
First Posted (Actual)
June 28, 2022
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMKUASKAR-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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