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Идёт набор NCT07712211

Association Between Pain Catastrophizing and PONV in Laparoscopic Cholecystectomy Patients

— Наблюдательное Vomiting, Postoperative Pain Nausea and Vomiting, Postoperative Pain Catastrophizing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Vomiting, Postoperative, Pain, Nausea and Vomiting, Postoperative, Pain Catastrophizing. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Relationship Between Pain Catastrophizing Scale and Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy

Обзор

This study aims to explore whether patients' tendency to exaggerate or focus on pain (pain catastrophizing) is related to experiencing nausea and vomiting after surgery. The study will include patients undergoing laparoscopic cholecystectomy. Before surgery, patients will answer questions measuring pain catastrophizing and rate their pain during intravenous cannulation. Nausea and vomiting will be assessed at various times during the first 24 hours after surgery. The results may help better understand how psychological factors affect postoperative symptoms.

Подробное описание

This study is designed as a prospective, cross-sectional, and observational study. The Pain Catastrophizing Scale (PCS) is a well-established self-report instrument developed to assess catastrophic thinking related to pain. It evaluates how individuals perceive and respond to pain, focusing on tendencies such as rumination, magnification, and feelings of helplessness. Evidence suggests that PCS is a strong predictor of pain intensity, independent of anxiety levels. In this study, the validated Turkish version of the Pain Catastrophizing Scale will be used.

Postoperative nausea, vomiting, and retching are common adverse events that can complicate recovery from anesthesia. Patients often perceive these symptoms as more distressing than postoperative pain, and they represent important outcomes affecting patient satisfaction and recovery.

The present study aims to investigate the relationship between pain perception during intravenous (IV) cannulation, pain catastrophizing levels, and postoperative nausea and vomiting. By evaluating numeric pain scores during IV access alongside PCS scores, this study seeks to explore whether preoperative pain perception and psychological factors are associated with the frequency of postoperative nausea and vomiting.

The findings of this study are expected to contribute to a better understanding of the role of psychological factors in postoperative symptoms and may help improve anesthesia practices by supporting more individualized, patient-centered perioperative care.

Первичные конечные точки

  • Incidence of postoperative nausea and vomiting (PONV) [Срок оценки: Within 24 hours postoperatively]
Вторичные конечные точки (1)
  • Association between IV cannulation pain and pain catastrophizing [Срок оценки: Preoperative period]

Критерии участия

Критерии включения

  • Adult patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-II-III
  • Scheduled for elective laparoscopic cholecystectomy
  • Able to provide informed consent

Критерии исключения

  • Age <18 or >65 years
  • Emergency surgery
  • ASA physical status > III
  • Pregnancy
  • Chronic opioid use
  • Known drug allergy
  • Psychiatric disorders
  • Neurological diseases (central or peripheral neuropathy)
  • History of cerebrovascular disease (stroke)
  • Chronic renal disease
  • Chronic pulmonary disease
  • Patients who refuse to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Trabzon Kanuni Education and Research Hospital — Trabzon

Публикации

  • Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022. PMID 10475299
  • Uğurlu M, Karakaş Uğurlu G, Erten Ş, Çayköylü A. Validity of Turkish form of Pain Catastrophizing Scale and modeling of the relationship between pain-related disability with pain intensity, cognitive, and emotional factors. Psychiatry and Clinical Psychopharmacology. 2017;27(2):189-196. doi:10.1080/24750573.2017.1322672
  • Borna S, Ho OA, Gomez-Cabello CA, Haider SA, Genovese A, Prabha S, Haider CR, Felton CL, McLeod CJ, Bruce CJ, Carter RE, Forte AJ. Impact of Demographics and Psychological Factors on Three-Day Postoperative Pain Perception Following Hand Surgery. J Clin Med. 2024 Dec 25;14(1):37. doi: 10.3390/jcm14010037. PMID 39797119

Идентификаторы

NCT: NCT07712211 · 10496660-2026/25027

Первоисточники (государственные реестры)

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