Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07593989
Enrollment
30
Registered
2026-05-18
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Pneumonia

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.

Interventions

BEHAVIORALroutine 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.

(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.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Caregiver Satisfaction1 day before dischargeCaregiver satisfaction will be assessed 1 day before discharge using a 5-point Likert scale.

Secondary

MeasureTime frameDescription
The resolution times of major symptoms and signsPeriproceduralThe 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 findingsPeriproceduralImprovement in chest imaging findings will be tracked through the hospital information system throughout hospitalization and after discharge.
Completion ratewithin 10 minutes after interventionProportion of participants completing the intervention

Contacts

CONTACTXinyi Rong
rongxinyi0208@126.com+86 18217121721

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026