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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Hatay, Turkey, 31080
        • Hatay Mustafa Kemal University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Progressive relaxation exercise
It consists of sessions involving deep breathing and stretching and relaxing the body.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in fatigue
Time Frame: At the beginning of the study, at weeks 1, 2, 3 and 4
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mustafa Kemal University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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