| CTRI Number |
CTRI/2021/03/031625 [Registered on: 01/03/2021] Trial Registered Prospectively |
| Last Modified On: |
05/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Balloon blowing exercise for children with bronchitis. |
|
Scientific Title of Study
|
Effectiveness of breathing exercise as a play way method after nubulization versus conventional nebulization on respiratory parameter among children with lower respiratory tract infections in selected hospitals at Mangaluru. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankitha kharvi |
| Designation |
4th bsc nursing student |
| Affiliation |
laxmi memorial college of nursing |
| Address |
AJ Towers,
Balmatta,
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9164341450 |
| Fax |
|
| Email |
sanjeevkharvi374@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankitha kharvi |
| Designation |
4th bsc nursing student |
| Affiliation |
laxmi memorial college of nursing |
| Address |
AJ Towers,
Balmatta,
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9164341450 |
| Fax |
|
| Email |
sanjeevkharvi374@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankitha kharvi |
| Designation |
4th bsc nursing student |
| Affiliation |
laxmi memorial college of nursing |
| Address |
AJ Towers,
Balmatta,
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9164341450 |
| Fax |
|
| Email |
sanjeevkharvi374@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi university of health sciences for shot term research grant. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of health sciences for short term research grants |
| Address |
4th T Block, Jayanagar, Bengaluru-560 041 |
| Type of Sponsor |
Other [Rajiv Gandhi University of health sciences for short-term research grants] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| shanthi S |
AJ Hospital and Research centre, |
pediatic ward, 7th floor,National highway 66,kuntikana, mangaluru. karnataka 575 004
Dakshina Kannada
KARNATAKA |
9164341450
shantjoe82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,AJ Institute of Medical sciences and research Centre, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J205||Acute bronchitis due to respiratory syncytial virus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
balloon blowing breathing exercise after asthalin nebulization for experimental group/only asthalin nebulization without baloon blowing exercise for control group |
balloon will be given to the child to blow maximum of 10 times for 15 minutes after asthalin nubulization for 2 consecutive days for the experimentall group/ control group only asthalin nebulization without balloon blowing breathing exercise. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age between 6 to 12 years
diagnosed with lower respiratory tract infection like bronchitis, bronchiolitis, pneumonia.
receiving medicated nebulization as per the prescription of doctor. |
|
| ExclusionCriteria |
| Details |
dyspnoea scale score above 4.
who are critically ill
who are confined to bed
who are diagnosed with asthma
with any congenital defects in mouth and nose
whose parents are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| playway method of breathing exercise after nebulization help to remove retained secretions.incraesed saturation level, reduction in respiratory rate , and normal breath sound. |
after 2 days. of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| child is comfortable, no dyspnoea , association of resiratory parameter with birth weight. |
after 2days of intervention. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
05/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
study published in the journal of Clinical and Diagnostic Research. Year : 2021 | Month : November | Volume : 15 | Issue : 11 | Page : LC01 - LC04 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Young
children experience an average of 6-8 respiratory illnesses per year in urban
setup and slightly lower in rural areas. Retained airway secretion is linked to
a wide range of respiratory illnesses. Breathing exercise plays a remarkable
role in airway clearance and parenchyma expansion. Quasi-experimental pretest and post test design was
used to select 20 children admitted to the pediatric ward with a diagnosis of
bronchitis, bronchiolitis and pneumonia. The level of dyspnoea was assessed
before nebulization using a Pediatric Dyspnoea Scale (PDS). Respiratory rate
per minute, oxygen saturation in percentage, chest expansion in centimeter and
respiratory sounds were assessed after nebulization. Interventional group was
advised to blow the balloon after nebulization for 15 minutes once a day for
2days consecutively.
Results: The mean age of children in the intervention group was 9.1± 2.71 while that in the control group was 8.75± 2.75.
Independent‘t’ test shows that
there was a statistical difference in the post test findings for oxygen
saturation and chest expansion.
Conclusion:
The study concluded that regular practice of balloon
blowing exercise improves oxygen saturation and chest expansion to a great
extent in children with lower respiratory tract infection.
|