- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07578870
Effects of Balloon Blowing Therapy and Bubble PEP on Oxygen Saturation, Dyspnea, and Enjoyment in Pediatric Pneumonia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 923224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Gulab Devi Chest Hospital Lahore
-
Contact:
- Imran Amjad, Phd
- Phone Number: 923224390125
- Email: imran.amjad@riphah.edu.pk
-
Contact:
- Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Balloon Blowing Therapy Group (BBTG)
Participants receive balloon blowing therapy along with baseline breathing exercises
|
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
Other Names:
|
|
Experimental: Bubble Positive Expiratory Pressure Group (Bubble PEP)
Participants receive Bubble PEP therapy along with baseline breathing exercises
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week
|
|
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.
|
1 week
|
|
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.
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahnoor ikram, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/Mahnoor
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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