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Bodźce sensoryczne podczas cięcia cesarskiego: badanie kohortowe z obserwacją długoterminową (PIONEER-MC)

29 lipca 2026 zaktualizowane przez: Juliana Barrera, University of British Columbia

Postrzeganie przez Pacjentkę Bodźców Zmysłowych Podczas Planowanego Cięcia Cesarskiego w Znieczuleniu Regionalnym Ośrodkowym (PIONEER): Badanie Kohortowe Podłużne.

To badanie będzie obejmować osoby planujące poród cesarskim cięciem ze znieczuleniem podpajęczynówkowym lub złożonym znieczuleniem podpajęczynówkowo-nadtwardówkowym. Zapytamy, jakie odczucia doświadczają podczas operacji, jak często one występują oraz czy którekolwiek z tych doznań są nieakceptowalne lub zbyt niekomfortowe.

Uczestnicy będą proszeni o odpowiedź na kilka krótkich pytań w sześciu ustalonych momentach podczas zabiegu. Wypełnią również krótkie kwestionariusze przed operacją i ponownie po porodzie (do 6 miesięcy), aby pomóc nam zrozumieć nastrój, stres i ogólne samopoczucie.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Często stosuje się cięcie cesarskie, a znieczulenie osiowe jest standardową techniką; jednak znaczna część pacjentek doświadcza bólu śródoperacyjnego lub niepokojących doznań. Dotychczasowe badania często opierają się na retrospektywnym przypominaniu, markerach zastępczych (np. stosowaniu leków) i zmiennych definicjach bólu śródoperacyjnego, z ograniczoną prospektywną charakterystyką doświadczeń sensorycznych, które pacjentki odczuwają, oraz tego, czy interpretują je jako bolesne lub w inny sposób nie do zaakceptowania.

PIONEER to prospektywne, długoterminowe badanie kohortowe, rekrutujące zdrowe pacjentki w ciąży poddawane planowanemu cięciu cesarskiemu w BC Women's Hospital. Głównym celem jest oszacowanie częstości występowania śródoperacyjnych bodźców sensorycznych, które są zgłaszane przez pacjentki jako nie do zaakceptowania (tj. doznań, które uczestniczka zgłasza jako nie do zaakceptowania i wymagające leczenia). Dane śródoperacyjne będą zbierane w sześciu określonych etapach chirurgicznych, od potwierdzenia blokady do zamknięcia skóry, za pomocą krótkich pytań do pacjentek. Obserwacja pooperacyjna i długoterminowa oceni dolegliwości poporodowe, depresję i objawy PTSD. Opieka kliniczna nie jest kierowana przez badanie; postępowanie anestezjologiczne i chirurgiczne pozostaje w gestii zespołu leczącego.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

1005

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H3N1
        • Rekrutacyjny
        • BC Women's Hospital
        • Kontakt:
        • Kontakt:
        • Pod-śledczy:
          • Roanne Preston, MD, FRCPC
        • Główny śledczy:
          • Juliana Kruthof, MD, MSc, FRCPC
        • Pod-śledczy:
          • William Shippam, MBChB, FRCA, FRCPC
        • Pod-śledczy:
          • Kathryn Clark, MD, FRCPC
        • Pod-śledczy:
          • Katherine M Seligman, MD, FRCPC D.ABA
        • Pod-śledczy:
          • Simon Massey, FRCA, FRCPC

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Zdrowe pacjentki w ciąży ≥36 tygodni ciąży poddawane planowemu cięciu cesarskiemu w znieczuleniu osiowym w Szpitalu BC Women's

Opis

Kryteria włączenia:

  • Zdrowe pacjentki w ciąży w wieku ciążowym ≥36 tygodni
  • Klasa 2-3 wg ASA Physical Status
  • Planowe cięcie cesarskie
  • Wiek ≥19 lat
  • Osoby mówiące po angielsku

Kryteria wykluczenia:

  • Znana historia przewlekłego bólu lub zaburzeń bólowych
  • Aktualne przyjmowanie leków o właściwościach przeciwbólowych
  • Znana historia schorzeń neurologicznych mogących upośledzać normalne czucie
  • Ciecie cesarskie wymagające dogięcia znieczulenia zewnątrzoponowego lub pierwotnego znieczulenia ogólnego

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Elective cesarean delivery under neuraxial anesthesia
Adults undergoing a planned (elective) cesarean delivery under single-shot spinal or combined spinal-epidural anesthesia at a participating tertiary-care obstetric center. All enrolled participants form a single prospective cohort and undergo the same study assessments: standardized self-report of intraoperative sensory experience at six predefined surgical timepoints (including, at each timepoint, whether a sensation is felt, a verbatim description of the sensation, a request for intervention if any, an intensity rating, and the anatomical location of the sensation), followed by longitudinal psychological assessment from a preoperative baseline through 6 months postpartum. Participants are not assigned to any intervention or exposure by the investigators; all anesthetic and surgical care is provided by the clinical team according to institutional standards.
Inny: Patient-initiated request for pharmacological intervention during cesarean delivery
The exposure of interest is the participant's own request, made during cesarean delivery, for the clinical team to provide a pharmacological intervention in response to an intraoperative sensory stimulus. At each of six predefined surgical timepoints, participants who report a sensation are asked whether they would like the team to act and, if so, whether they are requesting medication, some other action, or both. A request that includes medication constitutes the exposure. This is an observed, patient-initiated event; investigators do not assign or administer it, and all clinical management remains at the discretion of the treating team. This exposure is linked to the single study cohort (Elective cesarean delivery under neuraxial anesthesia).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus
Ramy czasowe: Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test (immediately before skin incision) through skin closure during the cesarean delivery (typically up to approximately 90 minutes)
At each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure), participants who report a sensation are asked: "Is there anything you would like us to do to address the sensation, like giving you medication or some other action?" A participant meets the outcome if, at one or more timepoints, the request includes medication (alone or together with some other action). Requests for some other action only, and timepoints with no affirmative response, are counted as non-events. The measure is the proportion (percentage) of participants with at least one qualifying request: the numerator is participants requesting a pharmacological intervention; the denominator is all analyzable participants. Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model.
Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test (immediately before skin incision) through skin closure during the cesarean delivery (typically up to approximately 90 minutes)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Thematic Categories of Patient-Reported Descriptions of Intraoperative Sensory Experiences
Ramy czasowe: Intraoperative; verbatim descriptions collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Verbatim responses to the standardized open-ended prompt "How would you describe the sensation you are feeling?", administered at each of six predefined surgical timepoints to participants who report a sensation, are analyzed by inductive qualitative content analysis. Sensory categories are derived inductively from participants' own descriptions rather than predefined classifications. Two independent investigators develop and refine a codebook through iterative open coding; inter-rater reliability is assessed on a random subset using Cohen's kappa (prespecified threshold 0.70) before full coding. The outcome is the set of thematic categories of intraoperative sensory experience, reported with the frequency of each category and its distribution across the six surgical timepoints. Reported per the Standards for Reporting Qualitative Research (SRQR).
Intraoperative; verbatim descriptions collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Incidence of Each Type of Patient-Reported Sensory Experience at Each Surgical Timepoint
Ramy czasowe: Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
At each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure), participants report whether they feel any sensation. Sensory categories are derived inductively from participants' own verbatim descriptions rather than predefined classifications (see the qualitative content analysis). For each surgical timepoint, the incidence of any reported sensation and of each inductively derived sensory category is calculated as the proportion (percentage) of participants reporting that sensation. Site-specific proportions are estimated with 95% Clopper-Pearson exact confidence intervals and pooled across participating centers using a DerSimonian-Laird random-effects model on the logit scale, with back-transformation to the proportion scale.
Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Intensity of Patient-Reported Intraoperative Sensation Measured on a 100-mm Visual Analog Scale at Each Surgical Timepoint
Ramy czasowe: Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Participants who report a sensation at a given surgical timepoint rate its intensity on a 100-mm horizontal Visual Analog Scale (VAS), anchored at the left end by "no sensation" (0 mm) and at the right end by "worst imaginable sensation" (100 mm); higher scores indicate greater intensity. The score is the distance in millimeters from the left anchor to the participant's mark (continuous, range 0 to 100 mm). Intensity is assessed at each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure). For each timepoint, VAS scores are summarized within each participating center as medians with interquartile ranges and pooled across centers by random-effects meta-analysis.
Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Anatomical Distribution of Patient-Reported Intraoperative Sensations Recorded on a Standardized Body Diagram at Each Surgical Timepoint
Ramy czasowe: Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Participants who report a sensation at a given surgical timepoint indicate its location on a standardized body diagram. Each marked location is coded to a set of predefined anatomical regions specified a priori in the body-diagram coding key. At each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure), the outcome is the proportion (percentage) of participants reporting sensation in each anatomical region. Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model on the logit scale, with back-transformation to the proportion scale. Distributions are additionally cross-tabulated by sensory category and by surgical timepoint to describe spatial and spatiotemporal patterns.
Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Temporal Pattern of Patient-Reported Intraoperative Sensations Across the Six Surgical Timepoints
Ramy czasowe: Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Using the timepoint-specific sensory data, the distribution of reported sensations is examined across the six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure) to characterize how the incidence and intensity of sensation change over the course of surgery. The outcome identifies the surgical timepoint(s) associated with the highest incidence of patient-initiated requests for pharmacological intervention and the highest median Visual Analog Scale intensity among reported sensations. Patterns are determined within each participating center and at the pooled level (DerSimonian-Laird random-effects model) to evaluate consistency of the temporal pattern across centers.
Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Proportion of Non-Pain Sensory Stimuli That Prompted a Patient Request for Pharmacological Intervention
Ramy czasowe: Intraoperative; sensory events and associated requests collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
This event-level outcome quantifies the extent to which sensations not explicitly described as painful nonetheless prompted a patient-initiated request for pharmacological intervention. Each reported sensory event (across all six surgical timepoints) is classified by the participant's own verbatim description as pain or non-pain (e.g., pressure, pulling, visceral sensation) using the inductively derived sensory categories. Among events not described as painful, the outcome is the proportion (percentage) that prompted a request for pharmacological intervention, analyzed by sensory category and by surgical timepoint. Unlike the patient-level primary outcome, this measure operates at the level of individual sensory events. Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model.
Intraoperative; sensory events and associated requests collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
Concordance Between Patient-Initiated Requests for Pharmacological Intervention and Receipt of Supplemental Intraoperative Analgesia
Ramy czasowe: Intraoperative; requests and analgesia administration recorded across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
For each participant, patient-initiated requests for pharmacological intervention are compared with the supplemental intraoperative analgesia actually administered by the clinical team (recorded by drug, dose, and route). The outcome comprises three measures, each reported as a proportion (percentage): the overall concordance rate (agreement between request and subsequent administration); the rate of unmet requests (a request not followed by administration of analgesia); and the rate of unsolicited analgesia administration (analgesia given without a preceding patient request). All clinical management decisions rest with the treating clinician; the research team records only the request and the intervention provided. Site-specific rates are pooled across participating centers using a DerSimonian-Laird random-effects model.
Intraoperative; requests and analgesia administration recorded across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins)
PTSD Checklist for DSM-5 (PCL-5) Total Score at Each Assessment Timepoint
Ramy czasowe: Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of post-traumatic stress symptoms. Each item is rated 0 ("not at all") to 4 ("extremely"), yielding a total score from 0 to 80; higher scores indicate greater symptom severity. At baseline, participants rate symptoms over the past month; at postpartum timepoints they reference the cesarean delivery as the index event. The total score is reported at each of five assessment timepoints: preoperative baseline, 24 to 48 hours postpartum, 6 weeks, 3 months, and 6 months postpartum. Scores are summarized within each participating center, and longitudinal trajectories are modeled using mixed-effects models with site-specific parameters pooled across centers by a DerSimonian-Laird random-effects model.
Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
Edinburgh Postnatal Depression Scale (EPDS) Total Score at Each Assessment Timepoint
Ramy czasowe: Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure that screens for depressive symptoms in the perinatal period. Each item is scored 0 to 3, yielding a total score from 0 to 30; higher scores indicate greater depressive symptom severity. The total score is reported at each of five assessment timepoints: preoperative baseline, 24 to 48 hours postpartum, 6 weeks, 3 months, and 6 months postpartum. Scores are summarized within each participating center, and longitudinal trajectories are modeled using mixed-effects models with site-specific parameters pooled across centers by a DerSimonian-Laird random-effects model.
Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days)
Peritraumatic Distress Inventory (PDI) Total Score at 24 to 48 Hours and 6 Weeks Postpartum
Ramy czasowe: 24 to 48 hours postpartum and 6 weeks postpartum (up to a maximum of 42 days)
The Peritraumatic Distress Inventory (PDI) is a 13-item self-report measure of emotional distress experienced during and immediately after a traumatic event. Each item is rated 0 ("not at all true") to 4 ("extremely true"), yielding a total score from 0 to 52; higher scores indicate greater peritraumatic distress. The total score is reported at two assessment timepoints: 24 to 48 hours postpartum (acute peritraumatic distress, the primary peritraumatic measure) and 6 weeks postpartum (recalled peritraumatic distress). The two administrations are analyzed independently as related but distinct constructs. Scores are summarized within each participating center and pooled across centers by a DerSimonian-Laird random-effects model. The PDI is not administered at baseline, as peritraumatic distress by definition relates to a specific event.
24 to 48 hours postpartum and 6 weeks postpartum (up to a maximum of 42 days)
Proportion of Participants Exceeding Validated Clinical Thresholds on the PCL-5, EPDS, and PDI at Each Postpartum Assessment Timepoint
Ramy czasowe: PCL-5 and EPDS: 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum. (up to a maximum of 183 days) PDI: 24 to 48 hours and 6 weeks postpartum (up to a maximum of 42 days).
At each postpartum assessment timepoint, the outcome is the proportion (percentage) of participants whose scores exceed validated clinical thresholds on each instrument: PCL-5 of 31 or higher (probable PTSD; scale 0 to 80), EPDS above 10 (depression risk; scale 0 to 30), and PDI of 15 or higher (significant peritraumatic distress; scale 0 to 52). On all three instruments, higher scores indicate greater symptom severity. PCL-5 and EPDS thresholds are assessed at 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum; the PDI threshold is assessed at 24 to 48 hours and 6 weeks postpartum. Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model.
PCL-5 and EPDS: 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum. (up to a maximum of 183 days) PDI: 24 to 48 hours and 6 weeks postpartum (up to a maximum of 42 days).
Association Between Patient-Initiated Requests for Pharmacological Intervention and Exceeding Clinical Thresholds on the PCL-5, EPDS, and PDI
Ramy czasowe: Psychological thresholds assessed at 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum (PDI at 24 to 48 hours and 6 weeks only), in relation to the intraoperative primary outcome (up to a maximum of 183 days)
This outcome evaluates whether participants who made a patient-initiated request for pharmacological intervention during surgery (the binary primary outcome) are more likely to exceed validated clinical thresholds on the psychological instruments postpartum: PCL-5 of 31 or higher, EPDS above 10, and PDI of 15 or higher. Within each participating center, the association is estimated using multivariable logistic regression adjusted for three prespecified confounders (dermatomal level of sensory block, number of previous cesarean deliveries, and preoperative STAI-6 score). Site-specific adjusted odds ratios are pooled across centers using a DerSimonian-Laird random-effects model and reported as pooled adjusted odds ratios with 95% confidence intervals at each postpartum timepoint. This analysis is exploratory and hypothesis-generating.
Psychological thresholds assessed at 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum (PDI at 24 to 48 hours and 6 weeks only), in relation to the intraoperative primary outcome (up to a maximum of 183 days)
Preoperative Anxiety (STAI-6) and Its Association With Intraoperative Sensory Outcomes and Patient-Initiated Treatment Requests
Ramy czasowe: STAI-6 measured at preoperative baseline (day of surgery); intraoperative sensory outcomes assessed across the six surgical timepoints during the cesarean delivery (up to a maximum of 1 day)
Preoperative anxiety is measured once at baseline using the 6-item State-Trait Anxiety Inventory short form (STAI-6). Each item is rated 1 to 4; the raw total (6 to 24) is multiplied by 20/6 to give a transformed score on the standard 20 to 80 scale, where higher scores indicate greater anxiety and a transformed score of 40 or higher denotes clinically significant anxiety. Reported as the mean transformed score and the proportion of participants exceeding the cutoff. The association between STAI-6 score and intraoperative sensory outcomes (the binary primary outcome, VAS intensity, and timepoint-specific incidence of sensation) is estimated within each participating center by multivariable regression adjusted for dermatomal level and number of previous cesarean deliveries, with site-specific estimates pooled by a DerSimonian-Laird random-effects model (adjusted odds ratios or beta coefficients, 95% CI).
STAI-6 measured at preoperative baseline (day of surgery); intraoperative sensory outcomes assessed across the six surgical timepoints during the cesarean delivery (up to a maximum of 1 day)
Proportion of Participants Who Indicated They Would Have Preferred General Anesthesia for Any Part of the Surgery
Ramy czasowe: Assessed once at the conclusion of surgery (end of the cesarean delivery) (up to a maximum 90 mins)
At the conclusion of surgery, all participants (regardless of whether they requested any intraoperative intervention) are asked a single standardized yes/no question: "Overall, would you have preferred to receive general anesthesia (i.e., be asleep) for any part of this surgery?" The outcome is the proportion (percentage) of participants answering yes. This captures the full spectrum of intraoperative experience, including participants who found their experience distressing without requesting treatment during surgery. Site-specific proportions are estimated with 95% Clopper-Pearson exact confidence intervals and pooled across participating centers using a DerSimonian-Laird random-effects model.
Assessed once at the conclusion of surgery (end of the cesarean delivery) (up to a maximum 90 mins)
Total Supplemental Intraoperative Intravenous Analgesia Administered, by Drug Type and Cumulative Dose
Ramy czasowe: Intraoperative; from neuraxial placement through the end of the cesarean delivery (up to a maximum of 90 mins)
The total supplemental intravenous analgesia administered by the clinical team during surgery is recorded by drug type and cumulative dose (including agents such as fentanyl, ketamine, and dexmedetomidine). The outcome reports, for each drug, the proportion of participants who received it and the cumulative dose administered (summarized as median with interquartile range or mean with standard deviation, as appropriate to the distribution). All administration decisions rest with the treating clinician; the research team records only what was given. Site-specific summaries are pooled across participating centers using a DerSimonian-Laird random-effects model.
Intraoperative; from neuraxial placement through the end of the cesarean delivery (up to a maximum of 90 mins)
In-Hospital Opioid Consumption From End of Surgery to Discharge, in Oral Morphine Milligram Equivalents (MME)
Ramy czasowe: From end of surgery to hospital discharge (up to a maximum of 7 days)
Total opioid consumption from the end of surgery to hospital discharge is recorded (including agents such as fentanyl, hydromorphone, and morphine) and converted to a common unit of oral morphine milligram equivalents (MME). The outcome is the cumulative MME per participant, summarized within each participating center as median with interquartile range or mean with standard deviation, as appropriate to the distribution, and pooled across participating centers using a DerSimonian-Laird random-effects model.
From end of surgery to hospital discharge (up to a maximum of 7 days)
Length of Hospital Stay From End of Surgery to Discharge
Ramy czasowe: From end of surgery to official hospital discharge (up to a maximum of 7 days)
Length of hospital stay is defined as the total duration, in hours, from the end of surgery to official hospital discharge. The outcome is summarized within each participating center as median with interquartile range or mean with standard deviation, as appropriate to the distribution, and pooled across participating centers using a DerSimonian-Laird random-effects model.
From end of surgery to official hospital discharge (up to a maximum of 7 days)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of British Columbia

Współpracownicy

Western University, Canada
University of Arkansas

Śledczy

  • Główny śledczy: Juliana Kruthof, MD, MSc, FRCPC, Department of Anesthesia BC Women's Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

20 lipca 2026

Zakończenie podstawowe (Szacowany)

30 maja 2027

Ukończenie studiów (Szacowany)

30 września 2027

Daty rejestracji na studia

Pierwszy przesłany

5 stycznia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 stycznia 2026

Pierwszy wysłany (Rzeczywisty)

14 stycznia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • H25-02656

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared. Aggregated and summary-level results will be made available through peer-reviewed publications and conference presentations, but individual-level data will not be released. This decision reflects the sensitive nature of the data collected, which include individual psychological assessments (post-traumatic stress, depression, and peritraumatic distress) and verbatim free-text descriptions of intraoperative experiences that carry a risk of participant re-identification, as well as the terms of participant consent and the Research Ethics Board approvals governing the study. Requests for additional aggregated analyses may be directed to the principal investigator and will be considered subject to Research Ethics Board approval.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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