NCT05435664

Brief 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 'Fatigue Severity Scale'. SPSS 22.0 package program will be used in the analysis of the data. p\<0.05 will be considered significant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

28 days

First QC Date

June 23, 2022

Last Update Submit

January 11, 2024

Conditions

Keywords

FatigueIntensive Care NursingProgressive Relaxation Exercises

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Progressive relaxation exercise

Control group

NO INTERVENTION

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.

Interventions

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

Intervention Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University Hospital

Hatay, 31080, Turkey (Türkiye)

Location

Related Publications (6)

  • 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

    BACKGROUND
  • 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.

    PMID: 31520865BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 30430667BACKGROUND
  • 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.

    PMID: 30295914BACKGROUND
  • 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.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There was no blinding due to the nature of the progressive relaxation exercise.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

April 1, 2022

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations