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Stimoli Sensoriali Durante il Parto Cesareo: Uno Studio di Coorte Longitudinale (PIONEER-MC)

29 luglio 2026 aggiornato da: Juliana Barrera, University of British Columbia

Percezione del Paziente degli Stimoli Sensoriali Durante il Parto Cesareo Elettivo in Anestesia Neuroassiale (PIONEER): Uno Studio Longitudinale di Coorte.

Questo studio seguirà le persone che hanno programmato un parto cesareo con anestesia spinale o spinale-epidurale combinata. Chiederemo quali tipi di sensazioni provano durante l'operazione, con quale frequenza si verificano e se alcune di queste sensazioni risultano inaccettabili o troppo sgradevoli.

Ai partecipanti verranno poste alcune brevi domande in sei momenti prestabiliti durante l'intervento. Completeranno anche brevi questionari prima dell'intervento e dopo il parto (fino a 6 mesi) per aiutarci a comprendere l'umore, lo stress e il benessere generale.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Il parto cesareo è comune e l'anestesia neurassiale è la tecnica standard; tuttavia, una proporzione significativa di pazienti sperimenta dolore intraoperatorio o sensazioni angoscianti. La ricerca esistente si basa spesso su ricordi retrospettivi, marcatori surrogati (ad esempio, l'uso di farmaci) e definizioni variabili del dolore intraoperatorio, con una caratterizzazione prospettica limitata delle esperienze sensoriali percepite dai pazienti e se le interpretano come dolorose o altrimenti inaccettabili.

PIONEER è uno studio prospettico di coorte longitudinale che arruola pazienti in gravidanza sane sottoposte a parto cesareo elettivo presso il BC Women's Hospital. L'obiettivo primario è stimare l'incidenza di stimoli sensoriali intraoperatori auto-riportati come inaccettabili (cioè sensazioni che il partecipante riferisce come inaccettabili e che necessitano di trattamento). I dati intraoperatori saranno raccolti in sei tappe chirurgiche definite, dalla conferma del blocco alla chiusura della cute, tramite brevi domande al paziente. Il follow-up postoperatorio e longitudinale valuterà il disagio postpartum, la depressione e i sintomi del PTSD. Le cure cliniche non sono dirette dallo studio; la gestione anestetica e chirurgica rimane a discrezione del team curante.

Tipo di studio

Osservativo

Iscrizione (Stimato)

1005

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H3N1
        • Reclutamento
        • BC Women's Hospital
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Roanne Preston, MD, FRCPC
        • Investigatore principale:
          • Juliana Kruthof, MD, MSc, FRCPC
        • Sub-investigatore:
          • William Shippam, MBChB, FRCA, FRCPC
        • Sub-investigatore:
          • Kathryn Clark, MD, FRCPC
        • Sub-investigatore:
          • Katherine M Seligman, MD, FRCPC D.ABA
        • Sub-investigatore:
          • Simon Massey, FRCA, FRCPC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Pazienti incinte sane con età gestazionale ≥36 settimane sottoposte a parto cesareo elettivo in anestesia neurassiale presso il BC Women's Hospital

Descrizione

Criteri di inclusione:

  • Pazienti in gravidanza sane con età gestazionale ≥36 settimane
  • Classe ASA Stato Fisico 2-3
  • Taglio cesareo elettivo
  • Età ≥19 anni
  • Parlanti inglese

Criteri di esclusione:

  • Storia nota di dolore cronico o disturbi del dolore
  • Attualmente in terapia con farmaci con proprietà analgesiche
  • Storia nota di condizioni neurologiche che possono compromettere la sensibilità normale
  • Taglio cesareo che richiede integrazione epidurale o anestesia generale de novo

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Thematic Categories of Patient-Reported Descriptions of Intraoperative Sensory Experiences
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of British Columbia

Collaboratori

Western University, Canada
University of Arkansas

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 luglio 2026

Completamento primario (Stimato)

30 maggio 2027

Completamento dello studio (Stimato)

30 settembre 2027

Date di iscrizione allo studio

Primo inviato

5 gennaio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2026

Primo Inserito (Effettivo)

14 gennaio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • H25-02656

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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