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Not yet recruitingNCT07593989Updated May 18, 2026

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

An interventional study of routine health education + a Child Life-Based Breathing Exercise Program and routine health education in Severe Pneumonia, sponsored by Children's Hospital of Fudan University. Not yet recruiting. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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.
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Conditions studied

  • Severe Pneumonia

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 30 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    control group

    In control group, participants received routine health education.

    Behavioral: routine health education

  • 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

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.

  • Behavioralroutine 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.

06

What researchers measure

Primary outcomes

  1. Caregiver Satisfaction

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

    Time frame: 1 day before discharge

Secondary outcomes

  1. 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.

    Time frame: Periprocedural

  2. Improvement in chest imaging findings

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

    Time frame: Periprocedural

  3. Completion rate

    Proportion of participants completing the intervention

    Time frame: within 10 minutes after intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07593989
Lead sponsor
Children's Hospital of Fudan University
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
May 18, 2026

Study contacts

Xinyi Rong
Contact
rongxinyi0208@126.com
+86 18217121721

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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