NCT05056571

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 20, 2021

Last Update Submit

September 20, 2021

Conditions

Keywords

headacheintensive care unitsoccupational Stressrelaxationwell-being

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in headache severity

    Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions

  • Change in Well-being

    Baseline measurements, at the end of 4., 8th week and one week after the completion of the interventions

Study Arms (2)

Relaxation exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

No attempt will be made during the research.

Interventions

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.

Relaxation exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Cardiovascular Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Occupational StressHeadache

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Zehra G Metin, PhD

    Hacettepe University Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bulent Güngörer, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asisstant

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 24, 2021

Study Start

September 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations