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Идёт набор NCT07308730

Pain Diary Use After Laparoscopic Cholecystectomy

Без фазы С лечением Cholelithiasis Postoperative Pain

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
В протоколе указаны: Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy.
Кому может быть актуально
Состояния в реестре: Cholelithiasis, Postoperative Pain. Базовые параметры: от 18 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

Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy

Обзор

This randomized controlled study aims to evaluate the effectiveness of using a pain diary in the assessment of early postoperative pain in patients undergoing laparoscopic cholecystectomy. Patients will be randomly assigned to a pain diary group or a control group receiving routine pain assessment. Postoperative pain intensity will be measured at predefined time points using standardized pain assessment tools. The study seeks to improve patient participation in postoperative pain evaluation without introducing additional pharmacological interventions.

Подробное описание

This is a single-center, randomized controlled trial conducted in patients undergoing elective laparoscopic cholecystectomy. Eligible patients are randomly assigned to either the intervention group or the control group using a block randomization method.

In the intervention group, postoperative pain assessment is performed using a patient-completed pain diary. The pain diary is developed based on the literature and expert opinions and is introduced to patients during the preoperative period. Patients are instructed on how to complete the pain diary, and pain intensity is recorded at rest and during movement at predefined postoperative time points.

In the control group, postoperative pain assessment is carried out using routine clinical practice with the Visual Analog Scale (VAS). Pain assessments are performed at the same postoperative time points as in the intervention group.

Additional pain-related assessments are conducted in both groups during the postoperative period. To minimize contamination between groups, patients in the intervention and control groups are followed in separate hospital rooms. Due to the visible nature of the pain diary, blinding is not feasible in this study.

Вмешательства

  • Поведенческое Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy
    This pain management protocol is specifically tailored for patients undergoing laparoscopic cholecystectomy and combines both scheduled pharmacological analgesics and non-pharmacological pain control measures. Unlike other studies, it includes daily pain diary monitoring to objectively track patient-reported postoperative pain and recovery outcomes.

Первичные конечные точки

  • Postoperative Pain Intensity and Pain Diary vs. VAS Comparison [Срок оценки: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)]
Вторичные конечные точки (1)
  • Postoperative Pain Intensity [Срок оценки: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)]

Критерии участия

Критерии включения

  • Admitted for elective laparoscopic cholecystectomy
  • Scheduled for first-time laparoscopic cholecystectomy
  • Aged 18 years or older
  • Able to speak, read, and understand Turkish
  • Literate
  • Communicative and cooperative
  • ASA score of 1, 2, or 3
  • Expected to stay at least 24 hours in the hospital post-surgery
  • Capable of understanding study instructions
  • Willing to participate voluntarily

Критерии исключения

  • Prolonged stay in the recovery unit due to extended effects of general anesthesia
  • Admission to intensive care unit postoperatively
  • Having chronic pain and receiving treatment for it
  • Being a cancer patient
  • Having a writing disability
  • Inability to communicate
  • Having cognitive, affective, verbal, visual, or auditory impairments
  • Diagnosed psychiatric disorders such as anxiety or depression and using related medications
  • Choosing to withdraw from the study after giving consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Menteşe State Hospital — Muğla

Идентификаторы

NCT: NCT07308730 · 250100 · Decision No: 102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗