Feasibility and Preliminary Efficacy of a Child Life-Based Breathing Exercise Program for Children Recovering From Severe Pneumonia: A Pilot Randomized Controlled Trial

Обзор

The goal of this pilot randomized controlled trial is to evaluate the feasibility and preliminary efficacy of a child life-based breathing exercise program for children recovering from severe pneumonia. The main questions it aims to answer are: * Is the child life-based breathing exercise program feasible for hospitalized children recovering from severe pneumonia? * Can the program improve caregiver satisfaction and promote recovery in children with severe pneumonia? Researchers will compare a child life-based breathing exercise program combined with routine health education with routine health education alone to determine whether the intervention improves rehabilitation outcomes. Participants will: * Receive either routine health education alone or routine health education combined with the child life-based breathing exercise program * Participate in breathing exercise training during hospitalization * Complete assessments of caregiver satisfaction and clinical recovery outcomes, including improvement in chest imaging findings and time to resolution of symptoms such as cough, fever, and dyspnea.

Вмешательства

• Поведенческое routine health education + a Child Life-Based Breathing Exercise Program
  In addition to routine health education, participants in the intervention group received a one-to-one respiratory training program based on a child life approach, delivered by the researcher.
• Поведенческое routine health education
  (1) information on common causes, typical symptoms, disease stages, and risk factors of severe pneumonia; (2) basic knowledge regarding commonly used treatments, such as anti-infective therapy, oxygen therapy, and nebulization, as well as home observation strategies; (3) dietary guidance emphasizing light and easily digestible foods, adequate hydration, and nutritional support while avoiding overly sweet, greasy, or cold foods; and (4) education on body temperature monitoring, recognition of abn

Первичные конечные точки

• Caregiver Satisfaction [Срок оценки: 1 day before discharge]

Вторичные конечные точки (3)

• The resolution times of major symptoms and signs [Срок оценки: Periprocedural]
• Improvement in chest imaging findings [Срок оценки: Periprocedural]
• Completion rate [Срок оценки: within 10 minutes after intervention]

Критерии участия

Критерии включения

• Children aged 6-18 years.
• Diagnosed with severe pneumonia and in the recovery phase.
• Written informed consent is obtained from caregivers, and assent is obtained from children when appropriate.

Критерии исключения

• Contraindications to breathing exercise, including: (a) hemodynamic instability (e.g., bradycardia or tachycardia, arrhythmia, hypotension or hypertension); (b) open sternal incision; (c) extracorporeal membrane oxygenation (ECMO); (d) acute phase of severe wheezing or stridor; and (e) severe pulmonary hypertension.
• Communication disorders.

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

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07593989 · CHFudanU0508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗