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Набор скоро начнётся NCT07222943

Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Без фазы С лечением Functional Abdominal Pain Disorders Irritable Bowel Syndrome (IBS) Functional Gastrointestinal Disorders (FGIDs) Gastrointestinal and Digestive Disorder

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: Guided Imagery Therapy.
Кому может быть актуально
Состояния в реестре: Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders (FGIDs), Gastrointestinal and Digestive Disorder. Базовые параметры: 7 лет — 12 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
Следующий шаг
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Официальное название

Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Обзор

Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet. Participants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application. This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.

Подробное описание

After fully disclosing the study design, intervention options, randomization scheme, and potential side effects of the interventions, caregivers and their children will document their respective informed consent and assent electronically. REDCap is a secure web application designed for surveys and databases. All data captured through REDCap will be encrypted and transmitted securely to HIPAA-compliant institutional servers for storage.

Participants and their caregivers will complete the following surveys at baseline, immediately post-therapy (8 weeks after baseline), and 3 months post-treatment through REDCap:

* 2-week Abdominal Pain and Stooling Diary * Children's Somatic Symptoms Inventory (child self-report and parent proxy-report) * Pain Catastrophizing Scale - Child Version * Pain Catastrophizing Scale - Parent Version * Pediatric Quality of Life Inventory 4.0 Generic Core (child self-report and parent proxy-report) * Behavior Assessment System for Children 3rd Ed (child self-report and parent proxy-report)

Вмешательства

  • Поведенческое Guided Imagery Therapy
    Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) sessions via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.

Первичные конечные точки

  • Abdominal Pain Intensity [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
Вторичные конечные точки (11)
  • Abdominal Pain Frequency [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Anxiety [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Anxiety [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Depression [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Depression [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Somatization [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Somatization [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Pain Catastrophizing Thoughts [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Pain Catastrophizing Thoughts [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Health-Related Quality of Life [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]
  • Health-Related Quality of Life [Срок оценки: Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment]

Критерии участия

Критерии включения

  • Texas Children's Pediatrics patients 7 to 12 years old at enrollment
  • A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary
  • Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.

Критерии исключения

  • Previous abdominal surgeries
  • Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)
  • Autism
  • Significant development delay
  • Psychosis
  • Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain
  • Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Baylor College of Medicine/Texas Children's Hospital — Austin
  • Baylor College of Medicine / Texas Children's Hospital — Houston

Идентификаторы

NCT: NCT07222943 · H-58306

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗