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Progressive Muscle Relaxation Exercise on Intensive Care Nurses

Primary Purpose

Occupational Stress

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive muscle relaxation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Occupational Stress focused on measuring headache, intensive care units, occupational Stress, relaxation, well-being

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ankara City Hospital Cardiovascular HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Relaxation exercise

Control

Arm Description

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.

No attempt will be made during the research.

Outcomes

Primary Outcome Measures

Change in Occupational Stress
Occupational stress severity will be measured based on patient report by the Occupational Stress Scale. Higher scores indicate increased occupational stress.

Secondary Outcome Measures

Change in headache severity
Headache severity will be measured based on patient report by the Visual Analog Scale. Lower scores indicate low level of headache.
Change in Well-being
Well-being will be measured by the Flourishing Scale. Higher scores on the scale mean better well-being.

Full Information

First Posted
September 20, 2021
Last Updated
September 20, 2021
Sponsor
Hacettepe University
Collaborators
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT05056571
Brief Title
Progressive Muscle Relaxation Exercise on Intensive Care Nurses
Official Title
The Effects of Online Progressive Muscle Relaxation Exercise on Occupational Stress, Headache and Well-being in Intensive Care Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Stress
Keywords
headache, intensive care units, occupational Stress, relaxation, well-being

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relaxation exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No attempt will be made during the research.
Intervention Type
Behavioral
Intervention Name(s)
Progressive muscle relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Occupational Stress
Description
Occupational stress severity will be measured based on patient report by the Occupational Stress Scale. Higher scores indicate increased occupational stress.
Time Frame
Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Secondary Outcome Measure Information:
Title
Change in headache severity
Description
Headache severity will be measured based on patient report by the Visual Analog Scale. Lower scores indicate low level of headache.
Time Frame
Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Title
Change in Well-being
Description
Well-being will be measured by the Flourishing Scale. Higher scores on the scale mean better well-being.
Time Frame
Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bulent Güngörer, Dr.
Phone
+09 312 552 60 00
Email
ankarasehir@saglik.gov.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra G Metin, PhD
Organizational Affiliation
Hacettepe University Faculty of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital Cardiovascular Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bülent Güngörer, Dr.
Phone
+09 312 552 60 00
Email
ankarasehir@saglik.gov.tr
First Name & Middle Initial & Last Name & Degree
Zehra G Metin, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Progressive Muscle Relaxation Exercise on Intensive Care Nurses

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