Pneumonia in ChildrenNCT07578870
Effects of Balloon Blowing Therapy and Bubble PEP on Oxygen Saturation, Dyspnea, and Enjoyment in Pediatric Pneumonia
A study testing Balloon Blowing Therapy and Bubble PEP in people with Pneumonia in Children, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pneumonia in Children
- What is being tested?
- Balloon Blowing Therapy and Bubble PEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Apr 2026to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gulab Devi Chest Hospital Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Comparative Effects of Balloon Blowing Therapy and Bubble PEP on Oxygen Saturation, Dyspnea, and Perceived Enjoyment in Children With Pneumonia
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.
Read the detailed description
Pneumonia is one of the main causes of morbidity and mortality in children worldwide and serious pediatric health concern. Symptoms including hypoxia, tachypnea, and dyspnea are brought on by inflammation and fluid buildup in the alveoli, which hinders gas exchange.Supportive oxygen therapy and antibiotics are usually used in conventional treatment, nonpharmacological therapies have become more prevalent to improve respiratory outcomes.Breathing techniques, such as bubble positive expiratory pressure (PEP) therapy and balloon blowing, are being used extensively to assist gas exchange, enhance lung function, and encourage airway clearing. These techniques are useful in children because these are easy to use, entertaining, and cost-effective.
This randomized clinical trial aims to compare the effects of Balloon Blowing Therapy (BBTG) and Bubble PEP Therapy (BPTG) on oxygen saturation, dyspnea, and perceived enjoyment in children with Pneumonia. Forty children aged 6-12 years diagnosed with pneumonia, fulfilling the eligibility criteria will be recruited through non-probability purposive sampling. Participants will be randomly assigned to two groups. Group A will receive Balloon Blowing Therapy along with baseline breathing techniques. Group B will receive Bubble PEP Therapy with the same baseline breathing techniques. Interventions will be administered twice daily in 5 consecutive days for 1 week. Outcome measures include oxygen saturation assessed via pulse oximeter, dyspnea assessed via Modified Borg Dyspnea Scale, and perceived enjoyment measured by a 5-point smiley Likert scale. Data will be analyzed using SPSS software.
- Conditions
- Pneumonia in Children
- Being tested
- Balloon Blowing Therapy, Bubble PEP
- Keywords
- Pneumonia, Balloon Blowing Therapy, Bubble PEP, Oxygen saturation
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Blowing TherapyDevice
Also called Baseline Breathing Exercises ( Diaphragmatic Breathing,Pursed-Lip Breathing)
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
Bubble PEPDevice
Also called Baseline Breathing Exercises ( Diaphragmatic Breathing,Pursed-Lip Breathing)
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
| Study group | Role | What they receive |
|---|---|---|
| Balloon Blowing Therapy Group (BBTG) | Experimental | Participants receive balloon blowing therapy along with baseline breathing exercises Receives: Device: Balloon Blowing Therapy |
| Bubble Positive Expiratory Pressure Group (Bubble PEP) | Experimental | Participants receive Bubble PEP therapy along with baseline breathing exercises Receives: Device: Bubble PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start14 Apr 2026
- Primary completion20 May 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia in ChildrenStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahnoor ikram, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578870
- Sponsor's protocol ID
- REC/RCR&AHS/25/0721
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40171163
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Balloon Blowing Therapy and Bubble PEP on Oxygen Saturation, Dyspnea, and Perceived Enjoyment in Children With Pneumonia
- ClinicalTrials.gov ID
- NCT07578870
- Acronym / sponsor ID
- REC/RCR&AHS/25/0721
- Conditions
- Pneumonia in Children
- Keywords
- Pneumonia, Balloon Blowing Therapy, Bubble PEP, Oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pneumonia is one of the main causes of morbidity and mortality in children worldwide and serious pediatric health concern. Symptoms including hypoxia, tachypnea, and dyspnea are brought on by inflammation and fluid buildup in the alveoli, which hinders gas exchange.Supportive oxygen therapy and antibiotics are usually used in conventional treatment, nonpharmacological therapies have become more prevalent to improve respiratory outcomes.Breathing techniques, such as bubble positive expiratory pressure (PEP) therapy and balloon blowing, are being used extensively to assist gas exchange, enhance lung function, and encourage airway clearing. These techniques are useful in children because these are easy to use, entertaining, and cost-effective.
This randomized clinical trial aims to compare the effects of Balloon Blowing Therapy (BBTG) and Bubble PEP Therapy (BPTG) on oxygen saturation, dyspnea, and perceived enjoyment in children with Pneumonia. Forty children aged 6-12 years diagnosed with pneumonia, fulfilling the eligibility criteria will be recruited through non-probability purposive sampling. Participants will be randomly assigned to two groups. Group A will receive Balloon Blowing Therapy along with baseline breathing techniques. Group B will receive Bubble PEP Therapy with the same baseline breathing techniques. Interventions will be administered twice daily in 5 consecutive days for 1 week. Outcome measures include oxygen saturation assessed via pulse oximeter, dyspnea assessed via Modified Borg Dyspnea Scale, and perceived enjoyment measured by a 5-point smiley Likert scale. Data will be analyzed using SPSS software.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balloon Blowing Therapy Group (BBTG) | Experimental | Device: Balloon Blowing TherapyParticipants receive balloon blowing therapy along with baseline breathing exercises |
| Bubble Positive Expiratory Pressure Group (Bubble PEP) | Experimental | Device: Bubble PEPParticipants receive Bubble PEP therapy along with baseline breathing exercises |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon Blowing TherapyAlso: Baseline Breathing Exercises ( Diaphragmatic Breathing,Pursed-Lip Breathing)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 | Device | Balloon Blowing Therapy Group (BBTG) |
| Bubble PEPAlso: Baseline Breathing Exercises ( Diaphragmatic Breathing,Pursed-Lip Breathing)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 | Device | Bubble Positive Expiratory Pressure Group (Bubble PEP) |
Primary outcome
Pulse oximeter
Time frame: 1 week
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.
Modified Borg Dyspnea Scale
Time frame: 1 week
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.
5-point Likert Scale with Faces
Time frame: 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 40171163Ding 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.
- Individual participant dataSharing planned: No
Related trials for Pneumonia in Children
Not yet recruiting
Effect of Nurse-Directed Therapeutic Positioning in Children With Pneumonia
Pediatric Pneumonia
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 1
A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children
GVHD (Acute or Chronic)
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahnoor ikram, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Blowing Therapy and Bubble PEP in people with Pneumonia in Children, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oximeter (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07578870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.