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Intensive Care NurseNCT05435664

The Effect of Progressive Relaxation Exercise on Fatigue in Intensive Care Nurses

A study testing Progressive relaxation exercise in people with Intensive Care Nurse and Fatigue, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Intensive Care Nurse, Fatigue
What is being tested?
Progressive relaxation exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2022to 29 Apr 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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Working for at least 6 months
  • Having a Fatigue Severity Scale score of 2.8 and above
  • Volunteer to participate in research

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hatay Mustafa Kemal University Hospital

    Hatay, 31080

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Progressive relaxation exercise
Keywords
Fatigue, Intensive Care Nursing, Progressive Relaxation Exercises
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive relaxation exerciseBehavioural

    It consists of sessions involving deep breathing and stretching and relaxing the body.

Study groups in NCT05435664
Study groupRoleWhat they receive
Intervention GroupExperimentalDuring 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.
Receives: Behavioral: Progressive relaxation exercise
Control groupNo interventionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fatigue

    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.

    Measured: At the beginning of the study, at weeks 1, 2, 3 and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start1 Apr 2022
  3. Primary completion29 Apr 2022
  4. Study completion29 Apr 2022

Resources

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
Model description
Randomized controlled
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435664
Sponsor's protocol ID
HMKUASKAR-02
Status last verified
Jan 2024
First submitted
23 Jun 2022
Last updated
12 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31520865

  • 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.

    PubMed 30430667

  • 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.

    PubMed 30295914

  • Askar Askar SE, Ovayolu OO, Ovayolu N. The effect of progressive relaxation exercise on fatigue level of intensive care nurses: A randomised controlled trial. Aust Crit Care. 2024 Sep;37(5):767-774. doi: 10.1016/j.aucc.2024.01.011. Epub 2024 Apr 15.

    PubMed 38627114

Questions about this trial

What is this clinical trial studying?

A study testing Progressive relaxation exercise in people with Intensive Care Nurse and Fatigue, 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 3 inclusion and 6 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 12 Jan 2024. 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?

Change in fatigue (time frame: At the beginning of the study, at weeks 1, 2, 3 and 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05435664, which also lists 6 linked publications.

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 12 Jan 2024.

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