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.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Pneumonia
• Intervention / Treatment: Behavioral: routine health education; Behavioral: routine health education + a Child Life-Based Breathing Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyi Rong; Phone Number: +86 18217121721; Email: rongxinyi0208@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Communication disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; In control group, participants received routine health education.	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 abnormal respiratory symptoms, basic airway clearance care, and maintenance of appropriate indoor temperature, humidity, and ventilation.
Experimental: intervention group; 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 + 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Satisfaction	Caregiver satisfaction will be assessed 1 day before discharge using a 5-point Likert scale.	1 day before discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The resolution times of major symptoms and signs	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.	Periprocedural
Improvement in chest imaging findings	Improvement in chest imaging findings will be tracked through the hospital information system throughout hospitalization and after discharge.	Periprocedural
Completion rate	Proportion of participants completing the intervention	within 10 minutes after intervention

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: CHFudanU0508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No