帝王切開分娩中の感覚刺激：縦断的コホート研究 (PIONEER-MC)
2026年7月29日 更新者：Juliana Barrera、University of British Columbia
脊髄くも膜下麻酔下における選択的帝王切開分娩中の患者の感覚刺激の知覚（PIONEER）：縦断的コホート研究
この研究では、脊椎麻酔または脊椎硬膜外併用麻酔による予定帝王切開を受ける方を対象に経過を追います。 手術中にどのような感覚を感じるか、その頻度、およびその感覚が許容できない、または不快すぎると感じられるかどうかを尋ねます。
参加者には、手術中の6つの設定された時点で短い質問をします。 また、手術前および出産後（最長6か月）に短いアンケートに回答していただき、気分、ストレス、全体的な健康状態を理解するのに役立てます。
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
詳細な説明
帝王切開は一般的であり、神経軸麻酔が標準的な技術ですが、有意な割合の患者が術中痛または苦痛を伴う感覚を経験します。 既存の研究は、しばしば回顧的想起、代理マーカー（例：薬物使用）、および術中痛の可変的な定義に依存しており、患者が知覚する感覚的経験と、それらを痛みとしてまたは受け入れがたいものとして解釈するかどうかの前向きな特徴付けは限られています。
PIONEERは、BCウィメンズ病院で選択的帝王切開を受ける健康な妊婦患者を登録する前向き縦断コホート研究です。 主目的は、受け入れがたいものとして自己報告される術中感覚刺激（すなわち、参加者が受け入れがたいと報告し、治療を必要とする感覚）の発生率を推定することです。 術中データは、ブロック確認から皮膚閉鎖までの6つの定義された外科的マイルストーンにおいて、短い患者質問を通じて収集されます。 術後および縦断的フォローアップでは、産後苦痛、うつ病、およびPTSD症状を評価します。 臨床ケアは研究によって指示されるものではなく、麻酔および外科的管理は治療チームの裁量に委ねられています。
研究の種類
研究の種類
観察的
入学 (推定)
入学
1005
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Juliana Kruthof, MD, MSc, FRCPC
- 電話番号：6335 604-875-2424
- メール：juliana.barrera@cw.bc.ca
研究場所
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British Columbia
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Vancouver、British Columbia、カナダ、V6H3N1
- 募集
- BC Women's Hospital
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コンタクト：
- Juliana Kruthof, MD, MSc, FRCPC
- 電話番号：6335 604-875-2158
- メール：juliana.barrera@cw.bc.ca
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コンタクト：
- Simon Massey, FRCA, FRCPC
- 電話番号：6335 604-875-2158
- メール：simon.massey@cw.bc.ca
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副調査官：
- Roanne Preston, MD, FRCPC
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主任研究者：
- Juliana Kruthof, MD, MSc, FRCPC
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副調査官：
- William Shippam, MBChB, FRCA, FRCPC
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副調査官：
- Kathryn Clark, MD, FRCPC
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副調査官：
- Katherine M Seligman, MD, FRCPC D.ABA
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副調査官：
- Simon Massey, FRCA, FRCPC
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
BCウーマンズ病院で神経軸麻酔下の選択的帝王切開分娩を受ける妊娠週数36週以上の健康な妊婦患者
説明
選定基準:
- 妊娠36週以上の健康な妊婦
- ASA身体状態分類2-3
- 予定帝王切開
- 年齢19歳以上
- 英語話者
除外基準:
- 慢性疼痛または疼痛障害の既知の既往歴
- 鎮痛作用のある薬剤を現在服用中
- 正常な感覚を損なう可能性のある神経疾患の既知の既往歴
- 硬膜外追加麻酔または新規全身麻酔を必要とする帝王切開
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
グループ/コホートの数
1
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
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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.
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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).
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus
時間枠：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)
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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.
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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)
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Thematic Categories of Patient-Reported Descriptions of Intraoperative Sensory Experiences
時間枠：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)
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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).
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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)
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Incidence of Each Type of Patient-Reported Sensory Experience at Each Surgical Timepoint
時間枠：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)
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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.
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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)
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Intensity of Patient-Reported Intraoperative Sensation Measured on a 100-mm Visual Analog Scale at Each Surgical Timepoint
時間枠：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)
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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.
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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)
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Anatomical Distribution of Patient-Reported Intraoperative Sensations Recorded on a Standardized Body Diagram at Each Surgical Timepoint
時間枠：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)
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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.
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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)
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Temporal Pattern of Patient-Reported Intraoperative Sensations Across the Six Surgical Timepoints
時間枠：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)
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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.
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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)
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Proportion of Non-Pain Sensory Stimuli That Prompted a Patient Request for Pharmacological Intervention
時間枠：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)
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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.
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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)
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Concordance Between Patient-Initiated Requests for Pharmacological Intervention and Receipt of Supplemental Intraoperative Analgesia
時間枠：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)
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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.
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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)
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PTSD Checklist for DSM-5 (PCL-5) Total Score at Each Assessment Timepoint
時間枠：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)
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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.
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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)
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Edinburgh Postnatal Depression Scale (EPDS) Total Score at Each Assessment Timepoint
時間枠：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)
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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.
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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)
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Peritraumatic Distress Inventory (PDI) Total Score at 24 to 48 Hours and 6 Weeks Postpartum
時間枠：24 to 48 hours postpartum and 6 weeks postpartum (up to a maximum of 42 days)
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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.
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24 to 48 hours postpartum and 6 weeks postpartum (up to a maximum of 42 days)
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Proportion of Participants Exceeding Validated Clinical Thresholds on the PCL-5, EPDS, and PDI at Each Postpartum Assessment Timepoint
時間枠：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).
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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.
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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).
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Association Between Patient-Initiated Requests for Pharmacological Intervention and Exceeding Clinical Thresholds on the PCL-5, EPDS, and PDI
時間枠：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)
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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.
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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)
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Preoperative Anxiety (STAI-6) and Its Association With Intraoperative Sensory Outcomes and Patient-Initiated Treatment Requests
時間枠：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)
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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).
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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)
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Proportion of Participants Who Indicated They Would Have Preferred General Anesthesia for Any Part of the Surgery
時間枠：Assessed once at the conclusion of surgery (end of the cesarean delivery) (up to a maximum 90 mins)
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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.
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Assessed once at the conclusion of surgery (end of the cesarean delivery) (up to a maximum 90 mins)
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Total Supplemental Intraoperative Intravenous Analgesia Administered, by Drug Type and Cumulative Dose
時間枠：Intraoperative; from neuraxial placement through the end of the cesarean delivery (up to a maximum of 90 mins)
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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.
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Intraoperative; from neuraxial placement through the end of the cesarean delivery (up to a maximum of 90 mins)
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In-Hospital Opioid Consumption From End of Surgery to Discharge, in Oral Morphine Milligram Equivalents (MME)
時間枠：From end of surgery to hospital discharge (up to a maximum of 7 days)
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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.
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From end of surgery to hospital discharge (up to a maximum of 7 days)
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Length of Hospital Stay From End of Surgery to Discharge
時間枠：From end of surgery to official hospital discharge (up to a maximum of 7 days)
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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.
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From end of surgery to official hospital discharge (up to a maximum of 7 days)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
協力者
捜査官
捜査官
- 主任研究者：Juliana Kruthof, MD, MSc, FRCPC、Department of Anesthesia BC Women's Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Jagodnik KM, Ein-Dor T, Chan SJ, Titelman Ashkenazy A, Bartal A, Barry RL, Dekel S. Screening for post-traumatic stress disorder following childbirth using the Peritraumatic Distress Inventory. J Affect Disord. 2024 Mar 1;348:17-25. doi: 10.1016/j.jad.2023.12.010. Epub 2023 Dec 7.
- Saulnier L, Chau A, Barrera J, Massey S. Influence of Planned Versus Unplanned Cesarean Delivery on Postpartum Peritraumatic Distress: A Prospective Observational Study. J Obstet Gynaecol Can. 2025 Nov;47(11):103114. doi: 10.1016/j.jogc.2025.103114. Epub 2025 Sep 10.
- Stanford SER. What is 'genuine' failure of neuraxial anaesthesia? Anaesthesia. 2022 May;77(5):523-526. doi: 10.1111/anae.15723. Epub 2022 Mar 25. No abstract available.
- Mehdiratta JE, Saab R, Chen Z, Li YJ, Habib AS. Patient and procedural risk factors for increased postoperative pain after cesarean delivery under neuraxial anesthesia: a retrospective study. Int J Obstet Anesth. 2020 Nov;44:60-67. doi: 10.1016/j.ijoa.2020.07.006. Epub 2020 Jul 21.
- Plaat F, Stanford SER, Lucas DN, Andrade J, Careless J, Russell R, Bishop D, Lo Q, Bogod D. Prevention and management of intra-operative pain during caesarean section under neuraxial anaesthesia: a technical and interpersonal approach. Anaesthesia. 2022 May;77(5):588-597. doi: 10.1111/anae.15717. Epub 2022 Mar 24.
- Stanford SE, Bogod DG. Failure of communication: a patient's story. Int J Obstet Anesth. 2016 Dec;28:70-75. doi: 10.1016/j.ijoa.2016.08.001. Epub 2016 Aug 23.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年7月20日
一次修了 (推定)
一次修了
2027年5月30日
研究の完了 (推定)
研究の完了
2027年9月30日
試験登録日
最初に提出
最初に提出
2026年1月5日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年1月5日
最初の投稿 (実際)
最初の投稿
2026年1月14日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年8月3日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月29日
最終確認日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- H25-02656
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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