NCT06285344

Brief Summary

This study aims to explore the impact of individual workload and fatigue levels on the sleep quality of operating room (OR) nurses, highlighting a critical aspect of healthcare professionals' well-being that directly affects patient safety and care quality. Operating room nurses face unique challenges due to the high-stress, fast-paced environment of surgical settings, which can lead to increased stress levels, emotional challenges, and a higher incidence of fatigue compared to other nursing specialties. Factors contributing to this fatigue include the demanding nature of surgical procedures, the need for constant vigilance, and the irregular hours associated with shift work, all of which can impair sleep quality. The literature review suggests that while the relationship between workload, fatigue, and sleep quality has been extensively studied in general nursing populations, there is a lack of specific focus on operating room nurses. These professionals work under distinct conditions that may exacerbate the effects of workload and fatigue on sleep quality, yet comprehensive studies targeting this group are limited. Understanding the nuances of how workload and fatigue specifically impact the sleep quality of OR nurses is crucial for developing targeted interventions aimed at improving their health and job performance, thereby enhancing patient care and safety. This cross-sectional and correlational study seeks to fill the gap in the literature by examining the specific effects of workload and fatigue on sleep perception among OR nurses. By identifying these relationships, the study aims to contribute valuable insights into strategies for mitigating fatigue and improving sleep among this critical group of healthcare workers, with the ultimate goal of ensuring both nurse well-being and patient safety.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 22, 2024

Last Update Submit

February 22, 2024

Conditions

Keywords

Operating Room NursesWorkloadFatigueSleep QualityPatient SafetyHealthcare ProfessionalsStress LevelsShift WorkSleep PerceptionNurse Well-beingSurgical SettingsEmotional ChallengesPatient Care Quality

Outcome Measures

Primary Outcomes (4)

  • Demographic Information Form

    This form gathers nurses' demographic details through seven multiple-choice questions, covering aspects like age, gender, marital status, nursing experience, operating room nursing experience, chronic conditions, and regular medication usage.

    up to 12 weeks

  • Individual Workload Perception Scale (IWPS)

    Initially developed in 2003 by Cox and colleagues and later adapted to Turkish in 2011 by Saygılı and Çelik, the IWPS assesses workload perception with a reliability coefficient of 0.894. It comprises 31 items across five categories: Supervisor Support, Colleague Support, Unit Support, Work Environment Workload Features, and Job Sustainability. Scoring is done on a 5-point Likert scale, with total scores ranging from 31 to 155, where higher scores suggest a more positive perception of workload.

    up to 12 weeks

  • Chalder Fatigue Scale (CFS)

    The CFS, developed by Chalder et al. in 1993 and revised in 2010, is designed to measure fatigue levels. It includes two subscales for Physical and Mental Fatigue, with reliability ranging from 0.72 to 0.87. The scale consists of 11 items, which can be scored using either a bi-modal (0-1) or a 4-point Likert scale (0-3), with higher scores indicating greater fatigue levels.

    up to 12 weeks

  • Richard-Campbell Sleep Questionnaire (RCSQ)

    Developed in 1987 by Richards, the RCSQ aims to evaluate different aspects of sleep quality using 6 items scored on a scale from 0 to 100. The Turkish version's reliability, assessed by Karaman Özlü and Özer in 2015, stands at 0.91. Higher scores on this scale denote better sleep quality, with detailed scoring ranges indicating varying levels of sleep quality from very poor to excellent.

    up to 12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study focuses on operating room (OR) nurses with at least one year of experience in various hospitals. These participants are chosen for their specialized knowledge in the surgical environment, ensuring they provide insights into workload, fatigue, and sleep quality. Inclusion is based on voluntary consent, aiming to collect data from a group well-versed in the unique challenges and stressors of OR settings. This demographic is particularly valuable for exploring how their demanding roles affect sleep and well-being.

You may qualify if:

  • Nurses who have been working as operating room nurses in the hospitals where the study is conducted for at least one year,
  • Nurses who are willing to participate in the study will be included.

You may not qualify if:

  • Data from nurses who wish to withdraw from the study at any stage will be excluded from the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islam Elagöz

Kilis, 79100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • islam elagöz, MsC

    devlet hastanesi

    STUDY DIRECTOR

Central Study Contacts

islam RA ELAGÖZ, MsC

CONTACT

Aynur Dr KOYUNCU, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher Asisstan

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

April 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

The IPD sharing plan ensures confidentiality and ethical compliance, using a secure, anonymized database for data access by verified researchers post-publication. Key aspects include anonymization, controlled access, a data use agreement, a sharing timeline, supporting documentation, and ethical oversight. This strategy balances scientific advancement with participant privacy.

Locations