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Набор скоро начнётся NCT06638437

Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)

Без фазы С лечением Chronic Postsurgical Pain Chronic Post-surgical Pain Chronic Postoperative Pain Chronic Post-operative 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: Cognitive-behavioral therapy.
Кому может быть актуально
Состояния в реестре: Chronic Postsurgical Pain, Chronic Post-surgical Pain, Chronic Postoperative Pain, Chronic Post-operative Pain. Базовые параметры: 8 лет — 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
Испания
Следующий шаг
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Обзор

Chronic postsurgical pain is a health problem with a great societal impact: approximately 20% of all children and adolescents undergoing surgery will develop chronic pain. Importantly, the risk and protective factors that are known (e.g., anxiety, catastrophizing, pain beliefs and pain coping) are modifiable, thus there is a huge potential for the development of both preventive and protective programs to avoid the transition from acute to chronic pain or reduce the impact in the lives of patients when it has already developed.

Подробное описание

The main objective of this project is to develop and test a program to prevent the development of chronic postsurgical pain in children and adolescents undergoing surgery in order to improve their quality of life (and that of their families). That program will be implemented in a mobile application.

This proposal will be implemented in 3 phases:

1. Development of the preventive program of chronic postsurgical pain and its implementation in a mobile application 2. Usability test of the mobile application 3. Clinical trial to test the effectiveness of the preventive program

Вмешательства

  • Поведенческое Cognitive-behavioral therapy
    The mobile application will include the following modules: 1. Psychoeducation: information about what to expect from each phase of the surgical process (i.e., pre-operative, the surgery itself and the post-operative). 2. Activation control techniques: to teach different activation control techniques such as relaxation, breathing techniques and mindfulness training. 3. Cognitive restructuring and problem solving: to teach how to change maladaptive pain-related beliefs for more adaptive ones and

Первичные конечные точки

  • Pain intensity (pre and postsurgical) [Срок оценки: Baseline (pre); daily for 15 days post-surgery; at 3 and 6 months follow-up]
  • Pain interference (pre and postsurgical) [Срок оценки: Baseline (pre), and at 3 and 6 months after surgery (post)]
Вторичные конечные точки (7)
  • Change in quality of life [Срок оценки: Baseline (pre) and 3 and 6 months follow-up]
  • Change in functional disability [Срок оценки: Baseline (pre) and 3 and 6 months follow-up]
  • Change in anxiety and depressive symptoms [Срок оценки: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in pain beliefs [Срок оценки: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in pain catastrophizing [Срок оценки: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in pain coping [Срок оценки: Baseline (pre), before surgery and after the CBT (pre), 3 and 6 months follow-up]
  • Change in sleep quality [Срок оценки: Baseline (pre); before surgery and after the CBT (pre), daily for 15 days post-surgery; at 3 and 6 months follow-up]

Критерии участия

Критерии включения

  • Having to undergo surgery
  • Being between 8 and 18 years old;
  • Having signed the informed consent
  • Having an ASA risk between I and III

Критерии исключения

  • Not being able to understand Spanish
  • Having a physical and/or cognitive impairment that interferes with understanding the instructions and handling of the application (e.g., moderate to severe intellectual disability, blindness)
  • Participating in another clinical trial
  • Undergoing an urgent surgical intervention
  • Being hospitalized in intensive care due to the need for ventilation or hemodynamic support or other complications
  • Having an ASA risk of IV
  • Not having signed the informed 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
Тройное слепое
Основная цель
Профилактика

Центры проведения

Испания · 3 центра
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Hospital Universitario 12 de octubre — Madrid
  • Hospital Joan XXIII — Tarragona

Идентификаторы

NCT: NCT06638437 · PID2020-113869RA-I00 · PID2020-113869RA-I00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗