NCT06859983

Brief Summary

Emergency departments are critical units where patients with life-threatening conditions and acute illnesses receive rapid interventions. Nurses working in these units aim to provide the best possible healthcare by intervening with patients at high risk of life-threatening situations. However, long working hours, inadequate working conditions, high stress, and critical patient care often lead to physiological issues among nurses. Fatigue and insomnia, which are commonly linked to burnout, are among the most frequent physiological problems. Insomnia is a condition characterized by poor and irregular sleep patterns occurring within a 24-hour period due to disruption of the circadian rhythm. Chronic insomnia, if persistent, triggers fatigue. Fatigue is a subjective condition that, when prolonged, negatively affects nurses' daily activities and reduces job performance. Moreover, increasing fatigue has significant adverse effects on alertness, attention, judgment, and mood. These effects can lead to accidents, errors in practice, and injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

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

First Submitted

Initial submission to the registry

February 28, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 2, 2025

Status Verified

February 1, 2025

Enrollment Period

7 days

First QC Date

February 28, 2025

Last Update Submit

May 1, 2025

Conditions

Keywords

Progressive muscle relaxation exerciseEmergency departmentnursefatigue severitysleep quality

Outcome Measures

Primary Outcomes (3)

  • Nurse Introductory Information Form

    The data collection form consists of 12 statements developed by the researchers as a result of the literature review, questioning age, gender, educational status, marital status, working time in the profession, working style, sleep quality and fatigue.

    he necessary evaluation will be made at the end of the first week.

  • Fatigue Severity Scale

    The scale developed by Krup (1989) consists of nine items assessing the general effect of fatigue on daily activities. The Turkish validity and reliability of the scale was performed by Armutlu et al. In the scale, individuals are asked to rate the fatigue they felt during the past week from 1 to 7. Each section is scored between 1 (strongly disagree) and 7 (strongly agree) (add 2 to 6). The total score is calculated by averaging the nine items. The cut-off value for pathological fatigue is set at 4 and above. The lower the total score, the lower the fatigue. Cronbach's alpha coefficient of the scale was 0.94 in the study of Armutlu et al.

    The necessary evaluation will be made at the end of the first week.

  • Pittsburgh Sleep Quality Index

    expressed in a single item, while others are expressed in a group of several items. Each item score ranges from "0" to "3". The total PDQI score is between 0 and 21. A score above 5 indicates that the sleep quality of the individual is poor. The Cronbach alpha value of the scale was found to be 0.80 in the study of Ağargün et al.

    The necessary evaluation will be made at the end of the first week.

Secondary Outcomes (3)

  • Nurse Introductory Information Form

    The necessary evaluation will be made at the end of the first week.

  • Fatigue Severity Scale

    The necessary evaluation will be made at the end of the second week.

  • Pittsburgh Sleep Quality Index

    The necessary evaluation will be made at the end of the second week.

Study Arms (1)

Emergency department nurses

EXPERIMENTAL

In the first phase, data collection will begin on the first day (n=35) with nurses, and the nurse introductory information form will be collected through face-to-face interviews. Then, at the end of each week during the 4-week period, nurses will complete the "Fatigue Severity Scale" and the "Pittsburgh Sleep Quality Index (PSQI)" four times. This will complete the pre-intervention evaluation.

Behavioral: progressive relaxation exercise

Interventions

he researcher will provide approximately 45 minutes of information about relaxation exercises to the nurses. During the application of progressive relaxation exercises, the necessary precautions to be taken during and after the exercise will be explained to the nurses. In the study, a sound recording that includes the PRE will be uploaded to each nurse's phone. The relaxation exercises CD created by the Turkish Psychologists Association will be used for the sound recording. The first section of the CD, which is 10 minutes long, defines deep relaxation, its purpose, and the precautions to be taken during the exercise. The second 30-minute section explains the relaxation exercises with the sound of a stream and verbal instructions. The third 30-minute section contains only relaxation music without any verbal instructions. After the training, nurses will be given the sound recording in CD form. Nurses will be asked to perform the PRE according to the instructions. They will be instructed

Emergency department nurses

Eligibility Criteria

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

You may qualify if:

  • Working in the emergency service unit,
  • No psychiatric disorder,
  • Can do progressive relaxation exercises,
  • Apply progressive relaxation exercises for one month,
  • No disease that prevents progressive relaxation exercise,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EmergenciesSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 5, 2025

Study Start

March 1, 2025

Primary Completion

March 8, 2025

Study Completion

May 1, 2025

Last Updated

May 2, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations