Progressive Muscle Relaxation Exercise on Intensive Care Nurses

September 20, 2021 updated by: Merve Gulbahar, Hacettepe University

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

Status

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

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

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

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 (Anticipated)

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.
100

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06800
        • Recruiting
        • Ankara City Hospital Cardiovascular Hospital
        • Contact:
        • Principal Investigator:
          • Zehra G Metin, PhD

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: Single

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: 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.
Behavioral: Progressive muscle relaxation
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

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 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

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.
Hacettepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zehra G Metin, PhD, Hacettepe University Faculty of Nursing

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.
September 1, 2021

Primary Completion (Anticipated)

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.
August 1, 2022

Study Completion (Anticipated)

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.
September 1, 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).
September 20, 2021

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.
September 20, 2021

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.
September 24, 2021

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.
September 24, 2021

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.
September 20, 2021

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.
September 1, 2021

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.
  • E2-21-814

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

product manufactured in and exported from the U.S.

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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