Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVolkan Gokmen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sleep, Mindfulness, and Shift-Level Safety Observation Toolkit
Other interventionNo 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Perianesthesia/PACU Nurses and Observed Shifts1 intervention
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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).2
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).3
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).4
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Volkan Gokmen
Lead sponsor
Agri Ibrahim Cecen University
Sponsor institution
Source ClinicalTrials.gov
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