Shift WorkNCT06285344
Impact of Workload and Fatigue on Sleep in OR Nurses
An observational study of Shift Work and Sleep Perception, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shift Work, Sleep Perception
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jun 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Data from nurses who wish to withdraw from the study at any stage will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Individual Workload and Fatigue Levels on Sleep Perception in Operating Room Nurses: A Multicenter Cross-Sectional and Correlational Study
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.
Read the detailed description
Operating room nurses play a critical role in surgical environments (Aorn 2020). The intense pace of the operating room environment can expose nurses to high workloads, increased stress levels, and emotional challenges (Alrawashdeh H 2021) (Teymoori, E 2022). The continuously changing and complex structure of modern healthcare services can further deepen these effects. Specifically, emergencies or unexpected complications during surgery can expose operating room nurses to different stress factors compared to other nurses (Teymoori, E 2022). The intense work environment of operating room nurses subjects them to high workloads and stressors, leading to stress and fatigue due to various factors (Jang 2021; Yuan SC 2011, Fang 2008, Shahzad, 2021). Fatigue represents a reduction in physical and emotional energy, a lack of motivation, and a general sense of exhaustion. Fatigue in nurses has been associated with factors such as high workloads, inadequate workplace support, challenging physical conditions, and shift work (Khande 2017). Particularly, day and night shifts can lead to increased workloads and consequently to higher rates of anxiety and depression (Warren 2008, Jang 2021 Barker 2011 Smith-Miller 2018 Clendon J 2019 Rathore H 2012 Yang YH 2012 Lee EJ 2014). This situation can lead to acute or chronic fatigue and even negative cycles (Barker LM 2011, Kawano 2008).
Workload is one of the biggest challenges faced by operating room nurses. The perception of workload among nurses can negatively affect their levels of fatigue, which in turn can reduce sleep quality (Cho, H. 2022; Dong 2017; Liu, Y., 2022). High workload can deplete nurses' physical and emotional energies (Akansel 2019)(Fan, 2021; Ghasemi,2019), leading to increased levels of fatigue. It can also negatively affect their decision-making abilities during critical surgical procedures. Moreover, high levels of fatigue can reduce the quality of care provided by nurses to patients, leading to negative effects on patient safety and treatment outcomes (Cho 2022)(Cho, H. 2022) (Dong 2017)(Metthevs 2011) (Liu, Y., 2022) and thus can affect sleep quality (Lin 2014).
Sleep quality is a critical factor for the overall health and job performance of operating room nurses. Generally, among health professionals, the primary causes of fatigue include circadian rhythm sleep disorders and sleep deprivation (Garrubba 2019, Jang 2021) Insomnia not only causes fatigue in nurses but can also negatively affect their psychomotor skills, reduce motivation and job performance, and impair their ability to maintain safe workplace behaviors (Dong 2017, Warren 2008, Choi UE 2016 Seol2018) This situation can lead to errors in procedures performed on patients and even harm to themselves [^8,Huckels-Baumgart, S.,2017) (Jones, T.2014) (Minnick, A 2012) (Pugh, C. 2011). Therefore, fatigue in operating room nurses not only affects them but also directly impacts patient safety and care quality (Garrubba 2019, Jang 2021) Preventing fatigue and eliminating the adverse conditions resulting from fatigue are essential for the safety of both patients and healthcare workers (Warren 2008, Smith-Miller 2014).
The effects of workload and fatigue levels on sleep quality among operating room nurses are significant issues for the nurses' overall health and job performance. The literature extensively examines the relationship between workload, fatigue, and sleep quality (Fan, 2021; Ghasemi,2019). Specifically, understanding the fatigue levels of operating room nurses is vital for the safety and health of both patients and nurses (Yamin 2020; Gurses 2009). The relationship between workload perception and sleep quality is critical for optimizing nurses' clinical performance and patients' health outcomes (Metthevs 2011). It has been indicated that a high perception of workload can have negative effects on fatigue and sleep quality.
The literature generally focuses on the general nurse population and has not sufficiently examined the demographic characteristics of operating room nurses and the potential effects of these characteristics on workload perception, fatigue, and sleep quality. Moreover, comprehensive studies specifically focusing on this topic are limited. The unique working conditions of operating room nurses, and the relationship between workload perception, fatigue, and sleep quality, should be examined more specifically and in detail. The findings obtained will contribute to the development of strategies to reduce fatigue among operating room nurses and improve their perception of sleep. This study will be conducted with the aim of determining the impact of individual workload and fatigue levels on sleep perception among operating room nurses and identifying the relationship between them.
- Conditions
- Shift Work, Sleep Perception
- Keywords
- Operating Room Nurses, Workload, Fatigue, Sleep Quality, Patient Safety, Healthcare Professionals, Stress Levels, Shift Work, Sleep Perception, Nurse Well-being, Surgical Settings, Emotional Challenges, Patient Care Quality
- Medical subject headings
- Fatigue, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift WorkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Responsible party
- Principal investigator, İslam Elagöz, Kilis 7 Aralik University
- Investigators
- islam elagöz, MsC, Study director, devlet hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285344
- Sponsor's protocol ID
- kilis_3
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Individual Workload and Fatigue Levels on Sleep Perception in Operating Room Nurses: A Multicenter Cross-Sectional and Correlational Study
- ClinicalTrials.gov ID
- NCT06285344
- Acronym / sponsor ID
- kilis_3
- Conditions
- Shift Work, Sleep Perception
- Keywords
- Operating Room Nurses, Workload, Fatigue, Sleep Quality, Patient Safety, Healthcare Professionals, Stress Levels, Shift Work
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Operating room nurses play a critical role in surgical environments (Aorn 2020). The intense pace of the operating room environment can expose nurses to high workloads, increased stress levels, and emotional challenges (Alrawashdeh H 2021) (Teymoori, E 2022). The continuously changing and complex structure of modern healthcare services can further deepen these effects. Specifically, emergencies or unexpected complications during surgery can expose operating room nurses to different stress factors compared to other nurses (Teymoori, E 2022). The intense work environment of operating room nurses subjects them to high workloads and stressors, leading to stress and fatigue due to various factors (Jang 2021; Yuan SC 2011, Fang 2008, Shahzad, 2021). Fatigue represents a reduction in physical and emotional energy, a lack of motivation, and a general sense of exhaustion. Fatigue in nurses has been associated with factors such as high workloads, inadequate workplace support, challenging physical conditions, and shift work (Khande 2017). Particularly, day and night shifts can lead to increased workloads and consequently to higher rates of anxiety and depression (Warren 2008, Jang 2021 Barker 2011 Smith-Miller 2018 Clendon J 2019 Rathore H 2012 Yang YH 2012 Lee EJ 2014). This situation can lead to acute or chronic fatigue and even negative cycles (Barker LM 2011, Kawano 2008).
Workload is one of the biggest challenges faced by operating room nurses. The perception of workload among nurses can negatively affect their levels of fatigue, which in turn can reduce sleep quality (Cho, H. 2022; Dong 2017; Liu, Y., 2022). High workload can deplete nurses' physical and emotional energies (Akansel 2019)(Fan, 2021; Ghasemi,2019), leading to increased levels of fatigue. It can also negatively affect their decision-making abilities during critical surgical procedures. Moreover, high levels of fatigue can reduce the quality of care provided by nurses to patients, leading to negative effects on patient safety and treatment outcomes (Cho 2022)(Cho, H. 2022) (Dong 2017)(Metthevs 2011) (Liu, Y., 2022) and thus can affect sleep quality (Lin 2014).
Sleep quality is a critical factor for the overall health and job performance of operating room nurses. Generally, among health professionals, the primary causes of fatigue include circadian rhythm sleep disorders and sleep deprivation (Garrubba 2019, Jang 2021) Insomnia not only causes fatigue in nurses but can also negatively affect their psychomotor skills, reduce motivation and job performance, and impair their ability to maintain safe workplace behaviors (Dong 2017, Warren 2008, Choi UE 2016 Seol2018) This situation can lead to errors in procedures performed on patients and even harm to themselves [^8,Huckels-Baumgart, S.,2017) (Jones, T.2014) (Minnick, A 2012) (Pugh, C. 2011). Therefore, fatigue in operating room nurses not only affects them but also directly impacts patient safety and care quality (Garrubba 2019, Jang 2021) Preventing fatigue and eliminating the adverse conditions resulting from fatigue are essential for the safety of both patients and healthcare workers (Warren 2008, Smith-Miller 2014).
The effects of workload and fatigue levels on sleep quality among operating room nurses are significant issues for the nurses' overall health and job performance. The literature extensively examines the relationship between workload, fatigue, and sleep quality (Fan, 2021; Ghasemi,2019). Specifically, understanding the fatigue levels of operating room nurses is vital for the safety and health of both patients and nurses (Yamin 2020; Gurses 2009). The relationship between workload perception and sleep quality is critical for optimizing nurses' clinical performance and patients' health outcomes (Metthevs 2011). It has been indicated that a high perception of workload can have negative effects on fatigue and sleep quality.
The literature generally focuses on the general nurse population and has not sufficiently examined the demographic characteristics of operating room nurses and the potential effects of these characteristics on workload perception, fatigue, and sleep quality. Moreover, comprehensive studies specifically focusing on this topic are limited. The unique working conditions of operating room nurses, and the relationship between workload perception, fatigue, and sleep quality, should be examined more specifically and in detail. The findings obtained will contribute to the development of strategies to reduce fatigue among operating room nurses and improve their perception of sleep. This study will be conducted with the aim of determining the impact of individual workload and fatigue levels on sleep perception among operating room nurses and identifying the relationship between them.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Data from nurses who wish to withdraw from the study at any stage will be excluded from the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic Information Form
Time frame: up to 12 weeks
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.
Individual Workload Perception Scale (IWPS)
Time frame: up to 12 weeks
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.
Chalder Fatigue Scale (CFS)
Time frame: up to 12 weeks
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.
Richard-Campbell Sleep Questionnaire (RCSQ)
Time frame: up to 12 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
islam elagöz, MsC study director
devlet hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shift Work and Sleep Perception, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact islam RA ELAGÖZ, MsC (+905304096124, islam.elagoz@kilis.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form (time frame: up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.