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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05056571
Other study ID # E2-21-814
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2022

Study information

Verified date September 2021
Source Hacettepe University
Contact Bulent Güngörer, Dr.
Phone +09 312 552 60 00
Email ankarasehir@saglik.gov.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Ankara City Hospital Cardiovascular Hospital Ankara Cankaya

Sponsors (2)

Lead Sponsor Collaborator
Hacettepe University Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Secondary 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. Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions
Secondary Change in Well-being 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
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