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Идёт набор NCT05382962

iCanCope With Post-Operative Pain (iCanCope PostOp)

Без фазы С лечением Pain, Chronic Pain, Chronic Post-Surgical

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: iCanCope Post Op Application.
Кому может быть актуально
Состояния в реестре: Pain, Chronic, Pain, Chronic Post-Surgical. Базовые параметры: 12 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
США, Канада
Следующий шаг
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Официальное название

iCanCope With Post-Operative Pain (iCanCope PostOp): Development of a Smartphone-based Pain Self-management Program for Adolescents Following Surgery

Обзор

There are few applications available in the community to help teenagers manage pain after surgery. The focus of this study is to better understand the pain experience of children after having surgery and to design a Smartphone app called "iCanCope with Post-Operative Pain" (iCanCope PostOp), to help children and parents to better manage pain at home after surgery. The app will help keep track of pain, provide information about the teenager's surgery and provides "in-the-moment" advice wherever and whenever the patient needs it.

Подробное описание

More than 80,000 Canadian children undergo surgery each year. Despite evidence-based pain management and clinical standards, moderate to severe postoperative pain in children is common. Inadequate postoperative pain management contributes to poor health outcomes, increased opioid use, and the development of chronic postsurgical pain. Successful postoperative pain management requires regular monitoring and treatment of pain after hospital discharge. Smartphones are nearly ubiquitous, and growing evidence supports their use to overcome barriers to pain care. Computerized clinical decision support systems (CDSS) can improve pain self-management by tracking symptoms over time and offering tailored evidence-informed pain management advice based on standardized algorithms. A comprehensive and sustainable approach is needed to address poorly managed pediatric postoperative pain in the home setting. To address these gaps in care, we are developing "iCanCope with Post-Operative Pain" (or iCanCope PostOp), a smartphone-based CDSS app that provides remote, in-the-moment advice to improve pain and health-related quality of life (HRQL) for adolescents following surgery.

Вмешательства

  • Поведенческое iCanCope Post Op Application
    The iCanCope program is designed to enhance pain self-management and self-efficacy, defined as perception of one's ability to successfully produce a desired effect in a task or behavior affecting their life. The intervention will be delivered on the iOS or Android smartphone platform depending on the participant's device. Usage of app features will be centrally tracked by the research team using Analytics Platform to Evaluate Effective Engagement (APEEE), developed at the Centre for Global eHeal

Первичные конечные точки

  • Participant Accrual and Dropout Rates [Срок оценки: 12 weeks]
  • Intervention fidelity [Срок оценки: 12 weeks]
  • Acceptability and Satisfaction [Срок оценки: 12 weeks]
  • Engagement with Intervention [Срок оценки: 12 weeks]
Вторичные конечные точки (7)
  • Pain intensity and interference [Срок оценки: 12 weeks]
  • Sleep Functioning [Срок оценки: 12 weeks]
  • Physical Function [Срок оценки: 12 weeks]
  • Depressive Symptoms [Срок оценки: 12 weeks]
  • Anxiety [Срок оценки: 12 weeks]
  • Overall health [Срок оценки: 12 weeks]
  • School attendance [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • aged 12 to 18 years;
  • own a smartphone compatible with the iCanCope app (iOS or Android);
  • diagnosed with adolescent idiopathic scoliosis or pectus carinatum or pectus excavatum;
  • are able to speak and read English; and
  • scheduled to undergo scoliosis or minimally invasive pectus repair surgery.

Критерии исключения

  • significant cognitive impairment or other co-existing medical condition that could limit the ability to use the iCanCope app, as identified by their health care provider;
  • participated in a previous study of iCanCope PostOp;
  • a diagnosed chronic pain condition not related to the surgical condition; or

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
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Boston Children's Hospital — Boston
Канада · 1 центр
  • Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT05382962 · 1000070021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗