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

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.

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Key information

Conditions

Severe Pneumonia Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

routine health education + a Child Life-Based Breathing Exercise Program

Behavioral

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.

routine health education

Behavioral

(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 abnormal respiratory symptoms, basic airway clearance care, and maintenance of appropriate indoor temperature, humidity, and ventilation.

Primary outcomes

Caregiver Satisfaction

Time frame: 1 day before discharge

Caregiver satisfaction will be assessed 1 day before discharge using a 5-point Likert scale.

Secondary outcomes

The resolution times of major symptoms and signs

Time frame: Periprocedural

The resolution times of major symptoms and signs, including cough, fever, and dyspnea, will be evaluated and recorded by the attending physicians according to clinical diagnostic and treatment criteria.
Improvement in chest imaging findings

Time frame: Periprocedural

Improvement in chest imaging findings will be tracked through the hospital information system throughout hospitalization and after discharge.
Completion rate

Time frame: within 10 minutes after intervention

Proportion of participants completing the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyi Rong

CONTACT

[email protected]

+86 18217121721

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: May 18, 2026
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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