Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia (ICAT)
Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia: Phase I of the Intraoperative Comfort Assessment Tool (ICAT) Validation
During a cesarean delivery done under spinal or epidural anesthesia, many patients notice sensations they weren't expecting things like pressure, pulling, tugging, or nausea even though the anesthesia blocks pain. These sensations can be distressing, and research suggests that difficult experiences during surgery may raise the risk of anxiety or post-traumatic stress after childbirth.
Right now, there's no dedicated tool for asking patients about these experiences during the procedure, which makes it hard for care teams to recognize, measure, or address them. This study is the first step toward building such a tool, called the Intraoperative Comfort Assessment Tool (ICAT). Researchers will interview 20 to 30 patients who recently had a cesarean delivery under spinal or epidural anesthesia at Mount Sinai Hospital in Toronto, asking them, in their own words, about what they felt during surgery. The interviews explore what different sensations felt like, how patients tell the difference between pressure, discomfort, and pain, and which symptoms bothered them most. By listening closely to how patients naturally describe their experiences, the team will identify common words and themes to build a more accurate, patient-centered questionnaire. Eventually, this tool could help anesthesiologists notice and respond to discomfort in real time during surgery, and give researchers a standard way to measure and improve the childbirth experience.
調査の概要
詳細な説明
Despite increasing emphasis on patient-centered care in obstetric anesthesia, there remains no validated, procedure-specific instrument designed to capture intraoperative discomfort during cesarean delivery under neuraxial anesthesia. Existing tools either focus exclusively on postoperative pain or assess satisfaction retrospectively, limiting their ability to inform real-time intraoperative management and quality improvement efforts. This study will therefore employ qualitative interviews to elicit patient-reported intraoperative experiences of discomfort to inform development of a novel patient-reported outcome measure of intraoperative discomfort, tentatively called The Intraoperative Comfort Assessment Tool (ICAT).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Fernanda Septimio Lanza Oliveira, MD
- 電話番号：5270 416-586-4800
- メール：Fernanda.Oliveira@sinaihealth.ca
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5G1X5
- 募集
- Mount Sinai Hospital
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コンタクト：
- Kristi Downey, MSc
- 電話番号：2366 416-586-4800
- メール：kristi.downey@uhn.ca
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副調査官：
- Ronald George, MD
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副調査官：
- Naveed Siddiqui, MD
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コンタクト：
- Fernanda Septimio Lanza Oliveira, MD
- 電話番号：5270 416-586-4800
- メール：Fernanda.Oliveira@sinaihealth.ca
-
副調査官：
- Margarita Blajeva, MD
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副調査官：
- Miki Peer, PhD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients who deliver by cesarean section under neuraxial anesthesia at Mount Sinai Hospital
説明
Inclusion Criteria:
- Adults undergoing elective or non-emergent cesarean delivery with Pfannenstiel or transverse incision, under spinal, epidural, or combined spinal-epidural anesthesia
- Able to communicate in English.
Exclusion Criteria
- Severe maternal illness preventing participation
- Cognitive impairment or inability to complete study procedures
- > 36 hours since cesarean delivery
Exclusion Criteria:
-
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients who have a Cesarean delivery
Patients who had Cesarean delivery, who experienced intraoperative pain or discomfort, and those who required intraoperative intravenous analgesic or sedative supplementation. |
Patients will be interviewed regarding their experience with pain or discomfort during their Cesarean delivery. The questions are open-ended. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient interview
時間枠：36 hours
|
Patients will be interviewed in person by a member of the research team and asked open ended questions. Interviews will be recorded, transcribed and coded for themes. Responses are not reported on any scale. The interview will take approximately 30 minutes to complete. |
36 hours
|
協力者と研究者
捜査官
- 主任研究者：Fernanda Septimio Lanza Oliveira, MD、MOUNT SINAI HOSPITAL
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。