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

NCT07593989 | Not Yet Recruiting

• 1 other identifier: CHFudanU0508
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Severe Pneumonia

Outcome Measures

Primary Outcomes (1)

• Caregiver Satisfaction

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

  1 day before discharge

Secondary Outcomes (3)

• The resolution times of major symptoms and signs

  Periprocedural

• Improvement in chest imaging findings

  Periprocedural

• Completion rate

  within 10 minutes after intervention

Study Arms (2)

control group

ACTIVE COMPARATOR

In control group, participants received routine health education.

Behavioral: routine health education

intervention group

EXPERIMENTAL

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

Interventions

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.

intervention group

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.

control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xinyi Rong

CONTACT

+86 18217121721; rongxinyi0208@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05