ClinicalTrials.gg
Not yet recruitingNCT07832721Updated Sep 24, 2026

Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. 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?
  2. 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?
  3. 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?
  4. Does trait mindfulness (MAAS) moderate the association between sleep/fatigue variables and shift-level safety performance?
  5. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

02

Conditions studied

  • Sleep
  • Fatigue
  • Patient Safety

Keywords

  • Perianesthesia Nursing
  • PACU
  • Sleep Quality
  • Mindfulness
  • Fatigue
  • Sleepiness
  • Shift Work
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In context

Fatigue

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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 criteria

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

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
Terms in these criteria, in plain language(1)

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.

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Sleep, Mindfulness, and Shift-Level Safety Observation Toolkit

Interventions

  • OtherSleep, 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.

06

What researchers measure

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).

07

Study locations

1 site
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References and documents

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 36707921 ↗
  • Özyeşil 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 12703651 ↗
  • Mavi 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 41969959 ↗
  • Dereli 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 34785424 ↗
  • Wyche 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 40021364 ↗
  • Al-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 38458149 ↗
  • Na 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 42360236 ↗
  • Smith 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 42536007 ↗
  • Sanya 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 40459481 ↗
  • Hazzard 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 23886284 ↗
  • Journal of PeriAnesthesia Nursing. Aims and Scope. Official Journal of the American Society of Perianesthesia Nurses. Elsevier.
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartEst.
Oct 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832721
Lead sponsor
Volkan Gokmen
Responsible party
Volkan Gokmen (Dr., Agri Ibrahim Cecen University) — Sponsor-investigator
First posted
Sep 22, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 24, 2026

Study contacts

Burcu Demir Gokmen, PhD
Contact
vgokmen@agri.edu.tr
+90 506 751 6888
Burcu Demir Gokmen, PhD
principal investigator · Ağrı İbrahim Çeçen Üniversitesi
Volkan Gokmen, PhD
study director · Ağrı İbrahim Çeçen Üniversitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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