| CTRI Number |
CTRI/2026/02/105017 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
22/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Do Play Based Breathing Exercises Improve Breathing and Behaviour in Children 6–12 Years Hospitalized with Chest Infections in Thiruvananthapuram Kerala |
|
Scientific Title of Study
|
Effectiveness of Breathing excercises as a playway method on respiratory parameters and behaviour reactions among children (6-12years) admitted with Lower respiratory tract infection in selected hospitals, Trivandrum, Kerala |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthika R |
| Designation |
PhD Scholar |
| Affiliation |
Dayananda Sagar University |
| Address |
Department of Child Health Nursing
College of Nursing Sciences
Under School of Health Sciences
Dayananda Sagar University
Harohalli Campus
Bengaluru
Pin code:562112
Bangalore
KARNATAKA
562112
India |
| Phone |
9495758695 |
| Fax |
|
| Email |
karthikar5565@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila J |
| Designation |
Professor |
| Affiliation |
Dayananda Sagar University |
| Address |
Department of Mental Health Nursing
College of Nursing Sciences
Under School of Health Sciences
Dayananda Sagar University
Harohalli Campus
Bengaluru
Bangalore
KARNATAKA
562112
India |
| Phone |
9606253062 |
| Fax |
|
| Email |
drsharmilaj-nsg@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Syama LS |
| Designation |
Associate Professor |
| Affiliation |
Little Flower College of Nursing |
| Address |
Department of Obstetric and Gynaecological Nursing
Little Flower College of Nursing
Under Jubilee Memorial Hospital
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7012226861 |
| Fax |
|
| Email |
jyothi08my@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Uthradam Thirunal Pattom Super Speciality Hospital
Pattom Palace PO Thiruvananthapuram
PIn 695004
Kerala
India
|
|
|
Primary Sponsor
|
| Name |
Karthika R |
| Address |
PhD Scholar
Department of Child Health Nursing
College of Nursing Sciences
Under School of Health Sciences
Dayananda Sagar University
Harohalli Campus
Bengaluru
Pin code:562112 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Bindhu Krishna |
SUT Hospital |
Department of Pediatrics
Pediatric Ward
Pattom Palace PO
Thiruvananthapuram
Thiruvananthapuram
KERALA |
9995154401
quality.dept@sutpattom.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH SREE UTHRADAM THIRUNAL HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: J20-J22||Other acute lower respiratory infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing Excercises |
Intervention Group
-Teaching and demonstration of breathing exercise as play way method
-Play way method includes:
. Belly breathing exercise
. Balloon blowing exercise
. Pin way breathing exercise
. Bubble blowing exercise
|
| Comparator Agent |
Participants will receive routine care |
Standardised care care |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6to 12 years who are diagnosed with lower respiratory tract infection and admitted to selected hospitals in Trivandrum District.
Children who can understand and speak Malayalam or English.
Children who are on antibiotic therapy
Child with oxygen saturation above 96%
Children who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Children who are with oxygen support and have severe chest indrawings.
Children with any congenital defects of mouth and nose like cleft lip or cleft palate.
Presence of any comorbid conditions.
Children with latex allergy.
Children with prior formal exposure to structured breathing exercise or respiratory physiotherapy
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in respiratory parameters |
at the time of discharge from the hospital
after three months from discharge
after six months from discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in behaviour reactions |
5days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2029 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STATEMENT
OF PROBLEM
Effectiveness
of breathing exercises as a play way method on respiratory parameters and
behavioural reactions among children 6 to 12 years admitted with Lower
respiratory tract infection in selected hospitals Trivandrum Kerala
OBJECTIVES
To assess the prevalence of lower respiratory tract infections among
school aged children in slected Hospitals in Trivandrum, Kerala
To evaluate the pre-intervention and
post-intervention scores of respiratory parameters and behavioural reactions
among children with lower respiratory tract infections on experimental and control group.
To determine the effectiveness of play way
method of breathing exercises on respiratory parameters and behavioural
reactions among children with lower respiratory tract infections on
experimental and control group.
To find out the association between
respiratory parameters and behavioural reactions among children with lower
respiratory tract infections with selected demographic variables. |