NCT04959214

Brief Summary

This study was conducted to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit three times a week for 1 month on sleep quality and severity of fatigue. The research is a pretest-posttest randomized controlled study with an intervention control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

June 29, 2021

Last Update Submit

July 1, 2021

Conditions

Keywords

NurseProgressive RelaxationSleepIntensive CareFatigue

Outcome Measures

Primary Outcomes (2)

  • Post-application fatigue severity rate of nurses working in the intensive care unit

    Fatigue severity scale The scale developed by Krup (1989) is a nine-item scale that evaluates the overall effect of fatigue on daily activities.In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. The total score is calculated by taking the average of nine items. The cut-off value for pathological fatigue was determined as 4 and above. The lower the total score, the less fatigue.

    Scales are filled before starting the application and at the end of the application after 1 month.

  • Decrease in sleep quality scale scores after the application

    The Pittsburgh Sleep Quality Index (PUKI, PSQI) was developed in 1989 by Buysse et al. (Buysee et al, 1989) to evaluate sleep quality in the last month. The scale consists of a total of 24 questions, 19 of which were answered by the individual and five of them by the relatives of the individual.Each item score varies between "0" and "3", and the sum of the scores of the items in the seven components gives the scale score of 18.The total PUKI score ranges from 0 to 21. If this score is above 5, it indicates that the sleep quality of the individual is poor.

    Scales are filled before starting the application and at the end of the application after 1 month.

Study Arms (2)

intervention: progressive relaxation exercise practice group

EXPERIMENTAL

intervention: progressive relaxation exercise practice group: A group of 30 intensive care nurses who will practice the progressive relaxation exercise at home 3 days a week for 1 month.

Behavioral: progressive relaxation egzersize

control: uninterrupted group

NO INTERVENTION

control: A group of 30 intensive care nurses who did not intervene for 1 month

Interventions

Performing exercises in a quiet environment for 45 minutes with the Turkish Psychologists Association CD. Filling the PSQI and FSS before and 1 month after the application

intervention: progressive relaxation exercise practice group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Without a psychiatric diagnosis,
  • Having a score of PUKI ≥5 and YŞÖ≥4,
  • Nurses who volunteered to participate in the study were included in the research sample.

You may not qualify if:

  • Experience of working in intensive care for less than 3 months,
  • Using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine, antidepressant, anxiolytic and narcotic analgesics that affect sleep quality,
  • Pregnant nurses were not included in the research sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Sarıçam, Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ParasomniasFatigue

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Songül Karadağ

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 13, 2021

Study Start

September 9, 2020

Primary Completion

April 12, 2021

Study Completion

June 29, 2021

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Results of intervention and control group scales before and after administration (statistical analysis) Introductory characteristics of the participants and participant consent form

Shared Documents
SAP, ICF
Time Frame
Data is continuously available after publication
Access Criteria
Data can be shared publicly
More information

Locations