An observational study in Sleep, Fatigue and Patient Safety, sponsored by Volkan Gokmen. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Volkan Gokmen · Observational
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.
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:
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:
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.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's planned enrollment of 300 is above the median of 99 across 406 observational studies indexed under Fatigue.
Browse Fatigue studies →Volkan Gokmen is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Nurse-Level Exclusion Criteria:
Shift-Level Inclusion Criteria:
Shift-Level Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Sleep, Mindfulness, and Shift-Level Safety Observation Toolkit
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.
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.
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).
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).
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
Number of near-miss safety events identified and documented in the Near-Miss and Event Log during each observed shift.
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
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).
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
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).
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).
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 156 non-industry observational studies under Fatigue, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 61. This study's planned 2 months is below that.
Counting every sponsor, half of 166 studies reached it within 24 months; a quarter within 7 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Volkan Gokmen