Feasibility and Preliminary Efficacy of a Child Life-Based Breathing Exercise Program for Children Recovering From Severe Pneumonia: A Pilot Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: routine health education + a Child Life-Based Breathing Exercise Program, routine health education.
- Who it may be relevant to
- Registry conditions: Severe Pneumonia. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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. - Behavioral 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
Primary outcome measures
- Caregiver Satisfaction [Time frame: 1 day before discharge]
Secondary outcome measures (3)
- The resolution times of major symptoms and signs [Time frame: Periprocedural]
- Improvement in chest imaging findings [Time frame: Periprocedural]
- Completion rate [Time frame: within 10 minutes after intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07593989 · CHFudanU0508