SleepNCT07832721
Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses
An observational study of Sleep and Fatigue, run by Volkan Gokmen at 1 site in Turkey (Türkiye).
Trial summary
Perianesthesia (preoperative and postanesthesia care unit, PACU) nurses work rotating, often extended shifts that can disrupt sleep and increase fatigue, both of which are recognized threats to patient safety in high-acuity perioperative settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Fatigue, Patient Safety
- What is being tested?
- Sleep, Mindfulness, and Shift-Level Safety Observation Toolkit
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Registered nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital, recruited from the nursing staff of a single center and followed prospectively across multiple of their own regularly scheduled shifts.
Nurse-Level Inclusion Criteria:
- Registered nurse currently working in the perianesthesia/PACU care areas of the study hospital
- Willing and available to be followed across multiple of the nurse's own shifts during the study period
- Willing to provide written informed consent
Nurse-Level Exclusion Criteria:
- Not directly involved in bedside perianesthesia/PACU patient care during the observation period (e.g., purely administrative role)
- Unwilling or unable to complete the baseline and per-shift study instruments
Shift-Level Inclusion Criteria:
- Regularly scheduled perianesthesia/PACU shift of a participating nurse occurring during the study period
- At least one applicable safety-critical care process occurs during the shift
Shift-Level Exclusion Criteria:
- Shift is shortened, cancelled, or substantially altered such that planned pre-shift/post-shift data collection and safety-process observation cannot be completed
- Study observer is unavailable to complete the safety-process observation for that shift
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ağrı Eğitim ve Araştırma Hastanesi
Ağrı
Burcu Özen Karabulut, MD, +90 472 215 6363, vgokmen@agri.edu.tr
Burcu Demir Gokmen, PhD
About this study
Official title: Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses: A Prospective Repeated-Measures Study
Perianesthesia (preoperative and postanesthesia care unit, PACU) nurses work rotating, often extended shifts that can disrupt sleep and increase fatigue, both of which are recognized threats to patient safety in high-acuity perioperative settings. Mindfulness, a trait-like capacity for present-moment, non-judgmental awareness, has been proposed as a psychological resource that may help nurses regulate attention and buffer the effects of sleep loss and fatigue on clinical performance. However, little is known about how sleep quality and quantity, shift-level fatigue, and mindfulness jointly relate to the day-to-day safety performance of perianesthesia nurses.
This prospective, repeated-measures, single-center study examines the relationships among sleep, mindfulness, and shift-level safety performance among nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital. Approximately 25 to 40 perianesthesia nurses will be followed across 8 to 12 of their own shifts each, with a target of 250 to 300 evaluable shift-level observations. At baseline, nurses will complete a demographic form together with the Pittsburgh Sleep Quality Index (B-PSQI) and the Mindful Attention Awareness Scale (MAAS). Before each observed shift, nurses will complete a brief pre-shift sleep and sleepiness diary; after each shift they will complete a post-shift acute-fatigue and shift-characteristics form. For each observed shift, trained researchers will use a researcher-developed Perianesthesia Safety Process Observation Form to document adherence to, and deviations from, applicable safety-critical care processes.
The primary outcome is the Shift-Level Perianesthesia Safety Deviation Rate, defined as the number of observed safety-process deviations divided by the number of applicable safety processes for that shift. Secondary outcomes include post-shift acute fatigue, the occurrence of near-miss events, and exploratory analyses of whether trait mindfulness moderates the associations between sleep/fatigue and safety performance. No patients are directly enrolled as research subjects; only nurses and their shifts are observed. Findings are expected to inform strategies to support nurse sleep, wellbeing, and safety-critical performance in perianesthesia settings.
Read the detailed description
Background and Rationale Sleep deprivation and shift work are established threats to human performance, attention, and decision-making, and nurses working rotating or extended shifts in high-acuity perioperative environments are particularly vulnerable to their effects. Perianesthesia nurses, who care for patients before and immediately after anesthesia and surgery, must perform frequent, time-critical, safety-critical tasks such as airway monitoring, medication verification, hemodynamic surveillance, and handoff communication, often under conditions of high cognitive load and interruption. Impaired sleep and accumulated fatigue have been associated in the broader nursing literature with increased rates of near-miss events, procedural deviations, and medication administration errors, but the specific relationship between sleep, fatigue, and shift-level safety performance has not been well characterized within perianesthesia/PACU nursing.
Mindfulness, defined as the capacity to sustain present-moment, non-judgmental awareness of one's internal state and surroundings, has been studied as a psychological trait that may protect against the performance-degrading effects of stress and fatigue. Nurses with higher trait mindfulness may be better able to notice early signs of fatigue-related lapses in attention and to compensate for them during safety-critical tasks. To date, however, few studies have examined whether trait mindfulness moderates the relationship between sleep/fatigue and observed safety performance at the shift level in perianesthesia nursing.
Conceptual Model This study is guided by a conceptual model in which shift-level and person-level sleep parameters (habitual sleep quality, pre-shift sleep duration, and pre-shift sleepiness) and post-shift acute fatigue are hypothesized to be associated with a higher rate of observed safety-process deviations during the shift. Trait mindfulness, measured once at baseline, is hypothesized to act as a moderator that attenuates (buffers) the strength of the sleep-safety and fatigue-safety associations. Because shifts are nested within nurses, and because the same nurse's shifts are likely to be correlated with one another, the design and analysis explicitly account for this nested (multilevel) structure.
Aims and Research Questions
The study addresses the following research questions:
- What is the level and variability of habitual sleep quality (B-PSQI), pre-shift sleep duration and sleepiness, and post-shift acute fatigue among perianesthesia/PACU nurses?
- What is the shift-level rate of observed deviations from safety-critical perianesthesia care processes (the Shift-Level Perianesthesia Safety Deviation Rate), and how does it vary across nurses and shifts?
- Are pre-shift sleep duration and sleepiness, and post-shift acute fatigue, associated with the shift-level safety deviation rate and with the occurrence of near-miss events?
- Does trait mindfulness (MAAS) moderate the association between sleep/fatigue variables and shift-level safety performance?
- What shift-level and nurse-level characteristics (e.g., shift length, workload, time of day, years of experience) are associated with safety performance, independent of sleep and fatigue?
Hypotheses H1: Shifts preceded by shorter sleep duration, higher pre-shift sleepiness, or followed by higher post-shift acute fatigue will show a higher Shift-Level Perianesthesia Safety Deviation Rate than shifts with more favorable sleep/fatigue profiles.
H1a: Higher trait mindfulness (MAAS) will be associated with a weaker (attenuated) association between pre-shift sleepiness and the safety deviation rate (a sleep × mindfulness moderation effect).
H1b: Higher trait mindfulness will similarly attenuate the association between post-shift acute fatigue and the safety deviation rate (a fatigue × mindfulness moderation effect).
Design Overview This is a prospective, observational, repeated-measures (within-subject) cohort study. Each participating nurse is followed across multiple of her or his own regularly scheduled shifts, so that both nurse-level (time-invariant) and shift-level (time-varying) predictors of safety performance can be examined. There is no randomization and no experimental intervention; nurses continue their usual clinical duties, and the study team observes and documents safety-process adherence during regularly occurring shifts.
Setting The study will be conducted in a single center, in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital (Ağrı Eğitim ve Araştırma Hastanesi). This is the same institutional setting used in the investigators' related perioperative nursing research.
Population and Eligibility Two levels of eligibility apply: nurse-level eligibility and shift-level eligibility.
Nurse-level inclusion criteria: registered nurses currently working in the perianesthesia/PACU care areas of the study hospital; willingness and availability to be followed across multiple shifts during the study period; and willingness to provide informed consent.
Nurse-level exclusion criteria: nurses who are not directly involved in bedside perianesthesia/PACU patient care during the observation period (e.g., purely administrative roles), and nurses unwilling or unable to complete the baseline and per-shift study instruments.
Shift-level inclusion criteria: regularly scheduled perianesthesia/PACU shifts of the participating nurse during the study period in which direct patient care involving at least one applicable safety-critical process occurs.
Shift-level exclusion criteria: shifts that are shortened, cancelled, or substantially altered such that the planned pre-shift/post-shift data collection and safety-process observation cannot be completed, and shifts for which the researcher-observer is unavailable to complete the observation form.
Because the population under study is hospital nursing staff rather than patients, and because no patient-level clinical intervention is applied, the study accepts healthy working adults (staff) rather than patients as its unit of observation; patients who are cared for during observed shifts are not themselves enrolled as research subjects, and no patient-identifiable data are collected.
Sample Size Based on the anticipated number of eligible perianesthesia/PACU nursing staff at the study hospital and an expected 8 to 12 observed shifts per nurse, the study targets enrollment of approximately 25 to 40 nurses, corresponding to a target of at least 250, and preferably approximately 300, evaluable shift-level observations. This target was selected to provide adequate power for multilevel models examining shift-level associations while accounting for the expected intraclass correlation of repeated shifts within nurses, and to allow for an anticipated degree of missing or unusable shift-level data (e.g., incomplete diaries or observation forms).
Data Collection Instruments
Data collection uses a five-part toolkit developed and/or adapted for this study:
- Baseline Form: a demographic and professional-characteristics questionnaire (age range, sex, years of nursing experience, years in perianesthesia/PACU care, education level, employment status, typical shift pattern) administered once at enrollment, together with the B-PSQI (an adapted Pittsburgh Sleep Quality Index instrument assessing habitual sleep quality over the preceding month) and the Mindful Attention Awareness Scale (MAAS), a validated self-report measure of trait mindfulness (dispositional attention to and awareness of present-moment experience), including its validated Turkish-language adaptation.
- Pre-Shift Sleep and Sleepiness Diary: a brief instrument completed by the nurse before each observed shift, capturing sleep duration and subjective sleep quality for the prior sleep period and a momentary sleepiness rating immediately before shift start.
- Post-Shift Acute Fatigue and Shift-Characteristics Form: completed by the nurse at the end of each observed shift, capturing a momentary/acute fatigue rating together with shift-level characteristics such as shift length, patient volume/acuity, and any self-reported workload or interruption burden during the shift.
- Perianesthesia Safety Process Observation Form: a researcher-developed structured observation instrument used by trained study personnel during each observed shift to document, for each applicable safety-critical perianesthesia care process (e.g., patient identification and hand-off verification, airway/oxygenation monitoring, medication verification, vital-sign/hemodynamic monitoring at required intervals, and other unit-specific safety-critical checks), whether the process was completed as required or whether a deviation occurred.
- Near-Miss and Event Log: a structured log used to record the occurrence of any near-miss safety events identified during the observed shift, independent of, but complementary to, the systematic process-deviation observations captured on the Safety Process Observation Form.
Procedures Eligible nurses will be informed about the study, and written informed consent will be obtained prior to any data collection. Consenting nurses will complete the Baseline Form, B-PSQI, and MAAS once, at enrollment. For each of the nurse's shifts selected for observation during the study period, the nurse will complete the Pre-Shift Sleep and Sleepiness Diary shortly before shift start and the Post-Shift Acute Fatigue and Shift-Characteristics Form at the end of the shift. During the same shift, a trained member of the research team, positioned to observe perianesthesia/PACU care without disrupting clinical workflow, will complete the Perianesthesia Safety Process Observation Form and the Near-Miss and Event Log. Data collection will continue until the target number of evaluable shift-level observations (approximately 250-300) has been reached across all participating nurses.
Data Analysis Plan Data will be analyzed using IBM SPSS and R. Descriptive statistics will characterize the nurse sample (demographic and professional characteristics, baseline B-PSQI and MAAS scores) and the shift-level sample (sleep, sleepiness, fatigue, and safety deviation rate distributions). Because shifts are nested within nurses, the primary analyses will use multilevel (hierarchical/mixed-effects) regression models with a random intercept for nurse to account for within-nurse correlation of repeated shift observations. The primary outcome, the Shift-Level Perianesthesia Safety Deviation Rate, will be modeled as a function of pre-shift sleep duration, pre-shift sleepiness, and post-shift acute fatigue, adjusting for relevant shift-level and nurse-level covariates (e.g., shift length, years of experience). Moderation analyses will test the interaction terms of sleep duration × MAAS and acute fatigue × MAAS to evaluate whether trait mindfulness attenuates the association between sleep/fatigue and safety performance (Hypotheses H1a and H1b). Secondary outcomes (post-shift acute fatigue as an outcome in its own right, and occurrence of near-miss events) will be analyzed using appropriate mixed-effects models (linear or generalized linear, as distributionally appropriate) with the same nested random-effects structure. Statistical significance will be set at a two-tailed alpha of 0.05, with effect sizes and confidence intervals reported alongside p-values.
Anticipated Difficulties The investigators anticipate several practical difficulties, including variability in nurses' shift schedules that may complicate the scheduling of repeated observations, the burden of completing pre-shift and post-shift instruments on busy clinical shifts, potential reactivity of nursing behavior to the presence of a researcher-observer (Hawthorne-type effects), and the logistical challenge of achieving observer availability across the full range of shift times (day, evening, night) needed for representative sampling.
Limitations As a single-center, observational, non-randomized study, causal inference regarding the effects of sleep and fatigue on safety performance is limited, and findings may not generalize beyond the study hospital's perianesthesia/PACU setting. The use of self-reported sleep, sleepiness, and fatigue measures is subject to recall and reporting biases, and observer-rated safety-process adherence may be influenced by observer reactivity effects despite efforts to minimize workflow disruption. The relatively modest anticipated sample size, while adequate for the planned multilevel analyses, limits statistical power for detecting smaller moderation effects. Finally, because participating nurses are aware of the study's focus on sleep and safety, social-desirability bias in self-report measures cannot be excluded.
Ethical Considerations This study involves the observation of nursing staff and their shift-level practices; patients cared for during observed shifts are not themselves research subjects, are not approached for consent, and no patient-identifiable information is collected or recorded as part of this study. All participating nurses will provide written informed consent prior to enrollment, and participation is voluntary, with no impact on employment status for nurses who decline to participate or who withdraw at any time. All collected data will be handled in accordance with applicable confidentiality and data-protection principles, with study data coded and stored securely, accessible only to the research team. The study protocol has been submitted to the Ağrı İbrahim Çeçen Üniversitesi Bilimsel Araştırmalar Etik Kurulu (Ağrı İbrahim Çeçen University Scientific Research Ethics Committee) for review.
- Conditions
- Sleep, Fatigue, Patient Safety
- Being tested
- Sleep, Mindfulness, and Shift-Level Safety Observation Toolkit
- Keywords
- Perianesthesia Nursing, PACU, Sleep Quality, Mindfulness, Fatigue, Sleepiness, Shift Work
- Medical subject headings
- Fatigue, Sleep Initiation and Maintenance Disorders, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep, Mindfulness, and Shift-Level Safety Observation ToolkitOther
No experimental intervention is administered. This entry describes the non-interventional assessment toolkit used to characterize each observed shift: a baseline demographic/B-PSQI/MAAS form completed once by each nurse; a pre-shift sleep and sleepiness diary; a post-shift acute fatigue and shift-characteristics form; and a researcher-developed Perianesthesia Safety Process Observation Form completed by trained observers to document adherence to, and deviations from, applicable safety-critical care processes during the shift.
| Study group | Role | What they receive |
|---|---|---|
| Perianesthesia/PACU Nurses and Observed Shifts | Registered nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital, followed prospectively across multiple of their own regularly scheduled shifts. For each nurse, baseline sleep quality (B-PSQI) and trait mindfulness (MAAS) are assessed once; for each observed shift, pre-shift sleep/sleepiness, post-shift acute fatigue, and researcher-observed safety-process adherence are recorded. There is no experimental intervention; nurses continue their usual clinical duties. Receives: Other: Sleep, Mindfulness, and Shift-Level Safety Observation Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift-Level Perianesthesia Safety Deviation Rate
For each observed shift, the number of observed deviations from applicable safety-critical perianesthesia care processes (documented via the researcher-developed Perianesthesia Safety Process Observation Form), divided by the number of applicable safety-critical processes for that shift.
Measured: Assessed once per observed shift, over the course of each nurse's participation in the study (approximately 8-12 shifts per nurse across the study period, up to approximately 6 months).
Secondary outcomes (4)
Post-Shift Acute Fatigue
Self-reported acute fatigue rating completed by the nurse on the Post-Shift Acute Fatigue and Shift-Characteristics Form at the end of each observed shift. Acute fatigue is rated using a single-item 0-10 Visual Analog/Numeric Rating Scale for Fatigue (0 = no fatigue at all to 10 = worst possible fatigue); higher scores indicate greater fatigue (a worse outcome).
Measured: Assessed once per observed shift, immediately at the end of the shift, over the course of each nurse's participation in the study (approximately 8-12 shifts per nurse, up to approximately 6 months).
Occurrence of Near-Miss Events
Number of near-miss safety events identified and documented in the Near-Miss and Event Log during each observed shift.
Measured: Assessed once per observed shift, over the course of each nurse's participation in the study (approximately 8-12 shifts per nurse, up to approximately 6 months).
Moderating Effect of Trait Mindfulness on the Sleep-Safety Association
Exploratory multilevel-model interaction term (pre-shift sleep duration x MAAS score, entered as predictors of the Shift-Level Perianesthesia Safety Deviation Rate) evaluating whether nurses' baseline trait mindfulness moderates the association between shift-level pre-shift sleep duration (hours) and the Shift-Level Perianesthesia Safety Deviation Rate. Trait mindfulness is measured once at baseline with the Mindful Attention Awareness Scale (MAAS; 15 items, mean of items each rated 1-6, total score range 1-6, higher scores indicating greater trait mindfulness). The reported measure is the sleep-duration x MAAS interaction-term coefficient from the multilevel model (unitless).
Measured: Baseline MAAS assessed once at enrollment; sleep duration and safety deviation rate assessed once per shift, over each nurse's participation (approx. 8-12 shifts/nurse, up to ~6 months).
Moderating Effect of Trait Mindfulness on the Fatigue-Safety Association
Exploratory multilevel-model interaction term (post-shift acute fatigue score x MAAS score, entered as predictors of the Shift-Level Perianesthesia Safety Deviation Rate) evaluating whether nurses' baseline trait mindfulness moderates the association between post-shift acute fatigue (0-10 Visual Analog/Numeric Rating Scale for Fatigue; higher scores indicate greater fatigue) and the Shift-Level Perianesthesia Safety Deviation Rate. Trait mindfulness is measured once at baseline with the Mindful Attention Awareness Scale (MAAS; 15 items, mean of items each rated 1-6, total score range 1-6, higher scores indicating greater trait mindfulness). The reported measure is the fatigue x MAAS interaction-term coefficient from the multilevel model (unitless).
Measured: Baseline MAAS assessed once at enrollment; post-shift acute fatigue and safety deviation rate assessed once per shift, over each nurse's participation (approx. 8-12 shifts/nurse, up to ~6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Volkan Gokmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Volkan Gokmen, Agri Ibrahim Cecen University
- Investigators
- Burcu Demir Gokmen, PhD, Principal investigator, Ağrı İbrahim Çeçen ÜniversitesiVolkan Gokmen, PhD, Study director, Ağrı İbrahim Çeçen Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832721
- Sponsor's protocol ID
- AICU-SLEEPMIND-2026
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bell T, Sprajcer M, Flenady T, Sahay A. Fatigue in nurses and medication administration errors: A scoping review. J Clin Nurs. 2023 Sep;32(17-18):5445-5460. doi: 10.1111/jocn.16620. Epub 2023 Jan 27.
PubMed 36707921Özyeşil Z, Arslan C, Kesici Ş, Deniz ME. Bilinçli Farkındalık Ölçeği'ni Türkçeye uyarlama çalışması. Eğitim ve Bilim. 2011;36(160):224-235.
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Mavi CU, Akdag B, Kok B, Ozturk EO, Aydemir O. Validity and Reliability of the Turkish Version of the Brief Pittsburgh Sleep Quality Index. Noro Psikiyatr Ars. 2026 Mar 26;63:387-392. doi: 10.29399/npa.29240. eCollection 2026.
PubMed 41969959Dereli M, Kahraman T. Validity and reliability of the Turkish version of single-item Sleep Quality Scale in healthy adults. Sleep Med. 2021 Dec;88:197-203. doi: 10.1016/j.sleep.2021.10.032. Epub 2021 Oct 30.
PubMed 34785424Wyche H, Weber A, McNulty T, Ruiz M, Keller S, Salmon ML, O'Donnell S, Horner J, Geiger-Brown J, McLeese RW, Freedenberg V, Anderson EW, Bost JE, Hinds PS. Interventions to promote well-being of nightshift nursing team members. J Pediatr Nurs. 2025 Mar-Apr;81:e121-e133. doi: 10.1016/j.pedn.2025.02.008. Epub 2025 Feb 28.
PubMed 40021364Al-Hammouri MM, Rababah JA. A brief mindfulness-based intervention, sleep quality, sleep duration, and fatigue among nurses: A randomized controlled trial. J Clin Psychol. 2024 Jul;80(7):1504-1514. doi: 10.1002/jclp.23677. Epub 2024 Mar 8.
PubMed 38458149Na J, Lee Y. Predictors of Patient Safety Care Activities among Postanesthesia Care Unit Nurses. J Perianesth Nurs. 2026 Jun 26:S1089-9472(26)00369-2. doi: 10.1016/j.jopan.2026.05.217. Online ahead of print.
PubMed 42360236Smith B. Addressing Burnout Among PeriAnesthesia Nurses Through a Mindfulness-Based Self-Help Intervention: A Quality Improvement Initiative. J Perianesth Nurs. 2026 Jul 31:S1089-9472(26)00423-5. doi: 10.1016/j.jopan.2026.07.004. Online ahead of print.
PubMed 42536007Sanya BK, Denny DL, Owens RA, Lindseth G, Petros T. Attitude and "Self-Compassion and Purpose" as Factors Influencing Nurses' Intentions to Engage in Mindful Self-care in the Perianesthesia Setting. J Perianesth Nurs. 2025 Dec;40(6):1485-1493. doi: 10.1016/j.jopan.2025.02.008. Epub 2025 Jun 3.
PubMed 40459481Hazzard B, Johnson K, Dordunoo D, Klein T, Russell B, Walkowiak P. Work- and nonwork-related factors associated with PACU nurses' fatigue. J Perianesth Nurs. 2013 Aug;28(4):201-9. doi: 10.1016/j.jopan.2012.06.010.
PubMed 23886284Journal of PeriAnesthesia Nursing. Aims and Scope. Official Journal of the American Society of Perianesthesia Nurses. Elsevier.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses: A Prospective Repeated-Measures Study
- ClinicalTrials.gov ID
- NCT07832721
- Acronym / sponsor ID
- AICU-SLEEPMIND-2026
- Conditions
- Sleep, Fatigue, Patient Safety
- Keywords
- Perianesthesia Nursing, PACU, Sleep Quality, Mindfulness, Fatigue, Sleepiness, Shift Work
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Volkan GokmenUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Sep 2026 (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.
Perianesthesia (preoperative and postanesthesia care unit, PACU) nurses work rotating, often extended shifts that can disrupt sleep and increase fatigue, both of which are recognized threats to patient safety in high-acuity perioperative settings. Mindfulness, a trait-like capacity for present-moment, non-judgmental awareness, has been proposed as a psychological resource that may help nurses regulate attention and buffer the effects of sleep loss and fatigue on clinical performance. However, little is known about how sleep quality and quantity, shift-level fatigue, and mindfulness jointly relate to the day-to-day safety performance of perianesthesia nurses.
This prospective, repeated-measures, single-center study examines the relationships among sleep, mindfulness, and shift-level safety performance among nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital. Approximately 25 to 40 perianesthesia nurses will be followed across 8 to 12 of their own shifts each, with a target of 250 to 300 evaluable shift-level observations. At baseline, nurses will complete a demographic form together with the Pittsburgh Sleep Quality Index (B-PSQI) and the Mindful Attention Awareness Scale (MAAS). Before each observed shift, nurses will complete a brief pre-shift sleep and sleepiness diary; after each shift they will complete a post-shift acute-fatigue and shift-characteristics form. For each observed shift, trained researchers will use a researcher-developed Perianesthesia Safety Process Observation Form to document adherence to, and deviations from, applicable safety-critical care processes.
The primary outcome is the Shift-Level Perianesthesia Safety Deviation Rate, defined as the number of observed safety-process deviations divided by the number of applicable safety processes for that shift. Secondary outcomes include post-shift acute fatigue, the occurrence of near-miss events, and exploratory analyses of whether trait mindfulness moderates the associations between sleep/fatigue and safety performance. No patients are directly enrolled as research subjects; only nurses and their shifts are observed. Findings are expected to inform strategies to support nurse sleep, wellbeing, and safety-critical performance in perianesthesia settings.
Detailed description
Background and Rationale Sleep deprivation and shift work are established threats to human performance, attention, and decision-making, and nurses working rotating or extended shifts in high-acuity perioperative environments are particularly vulnerable to their effects. Perianesthesia nurses, who care for patients before and immediately after anesthesia and surgery, must perform frequent, time-critical, safety-critical tasks such as airway monitoring, medication verification, hemodynamic surveillance, and handoff communication, often under conditions of high cognitive load and interruption. Impaired sleep and accumulated fatigue have been associated in the broader nursing literature with increased rates of near-miss events, procedural deviations, and medication administration errors, but the specific relationship between sleep, fatigue, and shift-level safety performance has not been well characterized within perianesthesia/PACU nursing.
Mindfulness, defined as the capacity to sustain present-moment, non-judgmental awareness of one's internal state and surroundings, has been studied as a psychological trait that may protect against the performance-degrading effects of stress and fatigue. Nurses with higher trait mindfulness may be better able to notice early signs of fatigue-related lapses in attention and to compensate for them during safety-critical tasks. To date, however, few studies have examined whether trait mindfulness moderates the relationship between sleep/fatigue and observed safety performance at the shift level in perianesthesia nursing.
Conceptual Model This study is guided by a conceptual model in which shift-level and person-level sleep parameters (habitual sleep quality, pre-shift sleep duration, and pre-shift sleepiness) and post-shift acute fatigue are hypothesized to be associated with a higher rate of observed safety-process deviations during the shift. Trait mindfulness, measured once at baseline, is hypothesized to act as a moderator that attenuates (buffers) the strength of the sleep-safety and fatigue-safety associations. Because shifts are nested within nurses, and because the same nurse's shifts are likely to be correlated with one another, the design and analysis explicitly account for this nested (multilevel) structure.
Aims and Research Questions
The study addresses the following research questions:
- What is the level and variability of habitual sleep quality (B-PSQI), pre-shift sleep duration and sleepiness, and post-shift acute fatigue among perianesthesia/PACU nurses?
- What is the shift-level rate of observed deviations from safety-critical perianesthesia care processes (the Shift-Level Perianesthesia Safety Deviation Rate), and how does it vary across nurses and shifts?
- Are pre-shift sleep duration and sleepiness, and post-shift acute fatigue, associated with the shift-level safety deviation rate and with the occurrence of near-miss events?
- Does trait mindfulness (MAAS) moderate the association between sleep/fatigue variables and shift-level safety performance?
- What shift-level and nurse-level characteristics (e.g., shift length, workload, time of day, years of experience) are associated with safety performance, independent of sleep and fatigue?
Hypotheses H1: Shifts preceded by shorter sleep duration, higher pre-shift sleepiness, or followed by higher post-shift acute fatigue will show a higher Shift-Level Perianesthesia Safety Deviation Rate than shifts with more favorable sleep/fatigue profiles.
H1a: Higher trait mindfulness (MAAS) will be associated with a weaker (attenuated) association between pre-shift sleepiness and the safety deviation rate (a sleep × mindfulness moderation effect).
H1b: Higher trait mindfulness will similarly attenuate the association between post-shift acute fatigue and the safety deviation rate (a fatigue × mindfulness moderation effect).
Design Overview This is a prospective, observational, repeated-measures (within-subject) cohort study. Each participating nurse is followed across multiple of her or his own regularly scheduled shifts, so that both nurse-level (time-invariant) and shift-level (time-varying) predictors of safety performance can be examined. There is no randomization and no experimental intervention; nurses continue their usual clinical duties, and the study team observes and documents safety-process adherence during regularly occurring shifts.
Setting The study will be conducted in a single center, in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital (Ağrı Eğitim ve Araştırma Hastanesi). This is the same institutional setting used in the investigators' related perioperative nursing research.
Population and Eligibility Two levels of eligibility apply: nurse-level eligibility and shift-level eligibility.
Nurse-level inclusion criteria: registered nurses currently working in the perianesthesia/PACU care areas of the study hospital; willingness and availability to be followed across multiple shifts during the study period; and willingness to provide informed consent.
Nurse-level exclusion criteria: nurses who are not directly involved in bedside perianesthesia/PACU patient care during the observation period (e.g., purely administrative roles), and nurses unwilling or unable to complete the baseline and per-shift study instruments.
Shift-level inclusion criteria: regularly scheduled perianesthesia/PACU shifts of the participating nurse during the study period in which direct patient care involving at least one applicable safety-critical process occurs.
Shift-level exclusion criteria: shifts that are shortened, cancelled, or substantially altered such that the planned pre-shift/post-shift data collection and safety-process observation cannot be completed, and shifts for which the researcher-observer is unavailable to complete the observation form.
Because the population under study is hospital nursing staff rather than patients, and because no patient-level clinical intervention is applied, the study accepts healthy working adults (staff) rather than patients as its unit of observation; patients who are cared for during observed shifts are not themselves enrolled as research subjects, and no patient-identifiable data are collected.
Sample Size Based on the anticipated number of eligible perianesthesia/PACU nursing staff at the study hospital and an expected 8 to 12 observed shifts per nurse, the study targets enrollment of approximately 25 to 40 nurses, corresponding to a target of at least 250, and preferably approximately 300, evaluable shift-level observations. This target was selected to provide adequate power for multilevel models examining shift-level associations while accounting for the expected intraclass correlation of repeated shifts within nurses, and to allow for an anticipated degree of missing or unusable shift-level data (e.g., incomplete diaries or observation forms).
Data Collection Instruments
Data collection uses a five-part toolkit developed and/or adapted for this study:
- Baseline Form: a demographic and professional-characteristics questionnaire (age range, sex, years of nursing experience, years in perianesthesia/PACU care, education level, employment status, typical shift pattern) administered once at enrollment, together with the B-PSQI (an adapted Pittsburgh Sleep Quality Index instrument assessing habitual sleep quality over the preceding month) and the Mindful Attention Awareness Scale (MAAS), a validated self-report measure of trait mindfulness (dispositional attention to and awareness of present-moment experience), including its validated Turkish-language adaptation.
- Pre-Shift Sleep and Sleepiness Diary: a brief instrument completed by the nurse before each observed shift, capturing sleep duration and subjective sleep quality for the prior sleep period and a momentary sleepiness rating immediately before shift start.
- Post-Shift Acute Fatigue and Shift-Characteristics Form: completed by the nurse at the end of each observed shift, capturing a momentary/acute fatigue rating together with shift-level characteristics such as shift length, patient volume/acuity, and any self-reported workload or interruption burden during the shift.
- Perianesthesia Safety Process Observation Form: a researcher-developed structured observation instrument used by trained study personnel during each observed shift to document, for each applicable safety-critical perianesthesia care process (e.g., patient identification and hand-off verification, airway/oxygenation monitoring, medication verification, vital-sign/hemodynamic monitoring at required intervals, and other unit-specific safety-critical checks), whether the process was completed as required or whether a deviation occurred.
- Near-Miss and Event Log: a structured log used to record the occurrence of any near-miss safety events identified during the observed shift, independent of, but complementary to, the systematic process-deviation observations captured on the Safety Process Observation Form.
Procedures Eligible nurses will be informed about the study, and written informed consent will be obtained prior to any data collection. Consenting nurses will complete the Baseline Form, B-PSQI, and MAAS once, at enrollment. For each of the nurse's shifts selected for observation during the study period, the nurse will complete the Pre-Shift Sleep and Sleepiness Diary shortly before shift start and the Post-Shift Acute Fatigue and Shift-Characteristics Form at the end of the shift. During the same shift, a trained member of the research team, positioned to observe perianesthesia/PACU care without disrupting clinical workflow, will complete the Perianesthesia Safety Process Observation Form and the Near-Miss and Event Log. Data collection will continue until the target number of evaluable shift-level observations (approximately 250-300) has been reached across all participating nurses.
Data Analysis Plan Data will be analyzed using IBM SPSS and R. Descriptive statistics will characterize the nurse sample (demographic and professional characteristics, baseline B-PSQI and MAAS scores) and the shift-level sample (sleep, sleepiness, fatigue, and safety deviation rate distributions). Because shifts are nested within nurses, the primary analyses will use multilevel (hierarchical/mixed-effects) regression models with a random intercept for nurse to account for within-nurse correlation of repeated shift observations. The primary outcome, the Shift-Level Perianesthesia Safety Deviation Rate, will be modeled as a function of pre-shift sleep duration, pre-shift sleepiness, and post-shift acute fatigue, adjusting for relevant shift-level and nurse-level covariates (e.g., shift length, years of experience). Moderation analyses will test the interaction terms of sleep duration × MAAS and acute fatigue × MAAS to evaluate whether trait mindfulness attenuates the association between sleep/fatigue and safety performance (Hypotheses H1a and H1b). Secondary outcomes (post-shift acute fatigue as an outcome in its own right, and occurrence of near-miss events) will be analyzed using appropriate mixed-effects models (linear or generalized linear, as distributionally appropriate) with the same nested random-effects structure. Statistical significance will be set at a two-tailed alpha of 0.05, with effect sizes and confidence intervals reported alongside p-values.
Anticipated Difficulties The investigators anticipate several practical difficulties, including variability in nurses' shift schedules that may complicate the scheduling of repeated observations, the burden of completing pre-shift and post-shift instruments on busy clinical shifts, potential reactivity of nursing behavior to the presence of a researcher-observer (Hawthorne-type effects), and the logistical challenge of achieving observer availability across the full range of shift times (day, evening, night) needed for representative sampling.
Limitations As a single-center, observational, non-randomized study, causal inference regarding the effects of sleep and fatigue on safety performance is limited, and findings may not generalize beyond the study hospital's perianesthesia/PACU setting. The use of self-reported sleep, sleepiness, and fatigue measures is subject to recall and reporting biases, and observer-rated safety-process adherence may be influenced by observer reactivity effects despite efforts to minimize workflow disruption. The relatively modest anticipated sample size, while adequate for the planned multilevel analyses, limits statistical power for detecting smaller moderation effects. Finally, because participating nurses are aware of the study's focus on sleep and safety, social-desirability bias in self-report measures cannot be excluded.
Ethical Considerations This study involves the observation of nursing staff and their shift-level practices; patients cared for during observed shifts are not themselves research subjects, are not approached for consent, and no patient-identifiable information is collected or recorded as part of this study. All participating nurses will provide written informed consent prior to enrollment, and participation is voluntary, with no impact on employment status for nurses who decline to participate or who withdraw at any time. All collected data will be handled in accordance with applicable confidentiality and data-protection principles, with study data coded and stored securely, accessible only to the research team. The study protocol has been submitted to the Ağrı İbrahim Çeçen Üniversitesi Bilimsel Araştırmalar Etik Kurulu (Ağrı İbrahim Çeçen University Scientific Research Ethics Committee) for review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perianesthesia/PACU Nurses and Observed Shifts | – | Other: Sleep, Mindfulness, and Shift-Level Safety Observation ToolkitRegistered nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital, followed prospectively across multiple of their own regularly scheduled shifts. For each nurse, baseline sleep quality (B-PSQI) and trait mindfulness (MAAS) are assessed once; for each observed shift, pre-shift sleep/sleepiness, post-shift acute fatigue, and researcher-observed safety-process adherence are recorded. There is no experimental intervention; nurses continue their usual clinical duties. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Registered nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital, recruited from the nursing staff of a single center and followed prospectively across multiple of their own regularly scheduled shifts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep, Mindfulness, and Shift-Level Safety Observation ToolkitNo experimental intervention is administered. This entry describes the non-interventional assessment toolkit used to characterize each observed shift: a baseline demographic/B-PSQI/MAAS form completed once by each nurse; a pre-shift sleep and sleepiness diary; a post-shift acute fatigue and shift-characteristics form; and a researcher-developed Perianesthesia Safety Process Observation Form completed by trained observers to document adherence to, and deviations from, applicable safety-critical care processes during the shift. | Other | Perianesthesia/PACU Nurses and Observed Shifts |
Primary outcome
Shift-Level Perianesthesia Safety Deviation Rate
Time frame: Assessed once per observed shift, over the course of each nurse's participation in the study (approximately 8-12 shifts per nurse across the study period, up to approximately 6 months).
For each observed shift, the number of observed deviations from applicable safety-critical perianesthesia care processes (documented via the researcher-developed Perianesthesia Safety Process Observation Form), divided by the number of applicable safety-critical processes for that shift.
4 secondary outcomes
Post-Shift Acute Fatigue
Time frame: Assessed once per observed shift, immediately at the end of the shift, over the course of each nurse's participation in the study (approximately 8-12 shifts per nurse, up to approximately 6 months).
Occurrence of Near-Miss Events
Time frame: Assessed once per observed shift, over the course of each nurse's participation in the study (approximately 8-12 shifts per nurse, up to approximately 6 months).
Moderating Effect of Trait Mindfulness on the Sleep-Safety Association
Time frame: Baseline MAAS assessed once at enrollment; sleep duration and safety deviation rate assessed once per shift, over each nurse's participation (approx. 8-12 shifts/nurse, up to ~6 months).
Moderating Effect of Trait Mindfulness on the Fatigue-Safety Association
Time frame: Baseline MAAS assessed once at enrollment; post-shift acute fatigue and safety deviation rate assessed once per shift, over each nurse's participation (approx. 8-12 shifts/nurse, up to ~6 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 36707921Bell T, Sprajcer M, Flenady T, Sahay A. Fatigue in nurses and medication administration errors: A scoping review. J Clin Nurs. 2023 Sep;32(17-18):5445-5460. doi: 10.1111/jocn.16620. Epub 2023 Jan 27.
- BackgroundÖzyeşil Z, Arslan C, Kesici Ş, Deniz ME. Bilinçli Farkındalık Ölçeği'ni Türkçeye uyarlama çalışması. Eğitim ve Bilim. 2011;36(160):224-235.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Background: PubMed 41969959Mavi CU, Akdag B, Kok B, Ozturk EO, Aydemir O. Validity and Reliability of the Turkish Version of the Brief Pittsburgh Sleep Quality Index. Noro Psikiyatr Ars. 2026 Mar 26;63:387-392. doi: 10.29399/npa.29240. eCollection 2026.
- Background: PubMed 34785424Dereli M, Kahraman T. Validity and reliability of the Turkish version of single-item Sleep Quality Scale in healthy adults. Sleep Med. 2021 Dec;88:197-203. doi: 10.1016/j.sleep.2021.10.032. Epub 2021 Oct 30.
- Background: PubMed 40021364Wyche H, Weber A, McNulty T, Ruiz M, Keller S, Salmon ML, O'Donnell S, Horner J, Geiger-Brown J, McLeese RW, Freedenberg V, Anderson EW, Bost JE, Hinds PS. Interventions to promote well-being of nightshift nursing team members. J Pediatr Nurs. 2025 Mar-Apr;81:e121-e133. doi: 10.1016/j.pedn.2025.02.008. Epub 2025 Feb 28.
- Background: PubMed 38458149Al-Hammouri MM, Rababah JA. A brief mindfulness-based intervention, sleep quality, sleep duration, and fatigue among nurses: A randomized controlled trial. J Clin Psychol. 2024 Jul;80(7):1504-1514. doi: 10.1002/jclp.23677. Epub 2024 Mar 8.
- Background: PubMed 42360236Na J, Lee Y. Predictors of Patient Safety Care Activities among Postanesthesia Care Unit Nurses. J Perianesth Nurs. 2026 Jun 26:S1089-9472(26)00369-2. doi: 10.1016/j.jopan.2026.05.217. Online ahead of print.
- Background: PubMed 42536007Smith B. Addressing Burnout Among PeriAnesthesia Nurses Through a Mindfulness-Based Self-Help Intervention: A Quality Improvement Initiative. J Perianesth Nurs. 2026 Jul 31:S1089-9472(26)00423-5. doi: 10.1016/j.jopan.2026.07.004. Online ahead of print.
- Background: PubMed 40459481Sanya BK, Denny DL, Owens RA, Lindseth G, Petros T. Attitude and "Self-Compassion and Purpose" as Factors Influencing Nurses' Intentions to Engage in Mindful Self-care in the Perianesthesia Setting. J Perianesth Nurs. 2025 Dec;40(6):1485-1493. doi: 10.1016/j.jopan.2025.02.008. Epub 2025 Jun 3.
- Background: PubMed 23886284Hazzard B, Johnson K, Dordunoo D, Klein T, Russell B, Walkowiak P. Work- and nonwork-related factors associated with PACU nurses' fatigue. J Perianesth Nurs. 2013 Aug;28(4):201-9. doi: 10.1016/j.jopan.2012.06.010.
- BackgroundJournal of PeriAnesthesia Nursing. Aims and Scope. Official Journal of the American Society of Perianesthesia Nurses. Elsevier.
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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.
Burcu Demir Gokmen, PhD principal investigator
Ağrı İbrahim Çeçen Üniversitesi
Volkan Gokmen, PhD study director
Ağrı İbrahim Çeçen Üniversitesi
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 Sleep and Fatigue, run by Volkan Gokmen 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?
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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu Demir Gokmen, PhD (+90 506 751 6888, vgokmen@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shift-Level Perianesthesia Safety Deviation Rate (time frame: Assessed once per observed shift, over the course of each nurse's participation in the study (approximately 8-12 shifts per nurse across the study period, up to approximately 6 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832721, which also lists 12 linked publications.
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 24 Sep 2026.