Effects of Balloon Blowing Therapy and Bubble PEP on Oxygen Saturation, Dyspnea, and Enjoyment in Pediatric Pneumonia

NCT07578870 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/24/Mahnoor
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia is a major cause of illness and death in children, leading to breathing difficulties and reduced oxygen levels due to impaired gas exchange. Non-pharmacological techniques like balloon blowing and Bubble PEP are simple, engaging methods used to improve respiratory function. This randomized clinical trial will compare the effects of Balloon Blowing Therapy and Bubble PEP on oxygen saturation, dyspnea, and enjoyment in 40 children with pediatric pneumonia over one week.

Conditions

Pneumonia in Children

Keywords

Pneumonia; Balloon Blowing Therapy; Bubble PEP; Oxygen saturation

Outcome Measures

Primary Outcomes (3)

• Pulse oximeter

  Oxygen saturation measured using a pulse oximeter to assess oxygen saturation in children with pneumonia.In healthy children, normal oxygen saturation (SpO₂) typically ranges from 95% to 100%, while values ≤92% indicate significant hypoxemia requiring medical attention.

  1 week

• Modified Borg Dyspnea Scale

  It is a patient-reported numerical scale assessing breathlessness during activity, ranging from 0 to 10, where 0 indicates no breathlessness and 10 indicates maximal breathlessness. Higher scores represent greater dyspnea.

  1 week

• 5-point Likert Scale with Faces

  This 5-point Likert scale with faces measures children's enjoyment and engagement during therapy. Scores range from 1 (not enjoyable) to 5 (highly enjoyable), with higher scores indicating greater enjoyment.

  1 week

Study Arms (2)

Balloon Blowing Therapy Group (BBTG)

EXPERIMENTAL

Participants receive balloon blowing therapy along with baseline breathing exercises

Device: Balloon Blowing Therapy

Bubble Positive Expiratory Pressure Group (Bubble PEP)

EXPERIMENTAL

Participants receive Bubble PEP therapy along with baseline breathing exercises

Device: Bubble PEP

Interventions

Balloon Blowing Therapy DEVICE

Balloon Blowing Therapy involves deep breathing followed by exhaling into a balloon to create positive pressure, improving lung expansion and airway clearance. It is combined with diaphragmatic and pursed-lip breathing, performed twice daily in 5 days for 1 week

Also known as: Baseline Breathing Exercises ( Diaphragmatic Breathing,Pursed-Lip Breathing)

Balloon Blowing Therapy Group (BBTG)

Bubble PEP DEVICE

Bubble PEP involves deep inhalation followed by exhalation through water to create resistance and positive pressure, improving lung expansion and airway clearance. It is combined with diaphragmatic and pursed-lip breathing, performed twice in 5 days for 1 week

Also known as: Baseline Breathing Exercises ( Diaphragmatic Breathing,Pursed-Lip Breathing)

Bubble Positive Expiratory Pressure Group (Bubble PEP)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 12 years
• Medically stable and cleared to perform breathing exercises
• Both genders will be included
• Presence of dyspnea according to the patient's statement
• Peripheral oxygen saturation (SpO2) \<94%

You may not qualify if:

• Children who are critically ill patients on bi-pep or a ventilator, as well as patients who were intubated and uncooperative
• Children with any oral surgery
• Participants were excluded from the study, if they had any contraindication to the use PEP therapy (severe haemoptysis)
• Refusal to participate or inability to complete full sessions

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Chest Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Ding L, Jiang Y. Biomarkers associated with the diagnosis and prognosis of Mycoplasma pneumoniae pneumonia in children: a review. Front Cell Infect Microbiol. 2025 Mar 18;15:1552144. doi: 10.3389/fcimb.2025.1552144. eCollection 2025.

  PMID: 40171163 BACKGROUND

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Mahnoor ikram, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

923224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask both groups about treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial (RCT), this study will include 40 pediatric participants age 6 -12 years, recruited from Gulab Devi Chest Hospital LHR. Participants will be randomly divided into 2 groups: one receiving Ballon Blowing Therapy with baseline breathing exercises and other group receive Bubble PEP with baseline breathing exercises. Outcome measures, including oxygen saturation (via Pulse Oximeter ), dypnea ( via Modified Borg Dyspnea Scale), and perceived enjoyment ( via 5-point Likert scale with faces or smiley icons ) will be recorded pre- and post- intervention. Statistical analysis will be performed using SPSS version 2023 to determine the intervention's effects.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: April 14, 2026
• Primary Completion: May 20, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)