| CTRI Number |
CTRI/2025/03/082752 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the role of breathing exercises in changing and improving the route of breathing through mouth to breathing through nose in children between the ages of 6 to 9 years in bhopal district |
|
Scientific Title of Study
|
ROLE OF BUTEYKO BREATHING EXERCISES IN CHANGING THE MODE OF BREATHING IN PRIMARY SCHOOL CHILDREN WITH MOUTH BREATHING SYNDROME IN BHOPAL DISTRICT. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajita Misra |
| Designation |
PhD scholar |
| Affiliation |
Lovely Professional University |
| Address |
School of allied medical sciences.
Block 4-213.
GT road , Phagwara
School of allied medical sciences.
Block 4-213.
GT road , Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
9925115098 |
| Fax |
|
| Email |
drajitamisra1907@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajita Misra |
| Designation |
PhD Scholar |
| Affiliation |
Lovely professional University |
| Address |
School of allied medical sciences.
Block 4-213.
GT road , Phagwara
School of allied medical sciences.
Block 4-213.
GT road , Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
9925115098 |
| Fax |
|
| Email |
drajitamisra1907@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajita Misra |
| Designation |
PhD Scholar |
| Affiliation |
Lovely Professional University |
| Address |
School of allied medical sciences.
Block 4-213.
GT road , Phagwara
School of allied medical sciences.
Block 4-213.
GT road , Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
9925115098 |
| Fax |
|
| Email |
drajitamisra1907@gmail.com |
|
|
Source of Monetary or Material Support
|
| lovely Professional University
School of allied medical sciences.
Block 4-213.
GT road , Phagwara, Punjab 144411 |
|
|
Primary Sponsor
|
| Name |
Lovely Professional University |
| Address |
School of allied medical sciences.
Block 4-213.
GT road , Phagwara, Punjab 144411 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Zaki Anwer |
Lovely Professional University |
School of allied medical sciences.
Block 4-213.
GT road , Phagwara
Kapurthala
PUNJAB |
9816285755
zakianwer.1974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-LPU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mouth breathing syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko breathing technique |
Nasal breathing and breath holding exercises for 6 months |
| Comparator Agent |
Exercises used for training to keep mouth closed and strengthening orbicularis oris muscle |
keep mouth closed and strengthening orbicularis oris muscle |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Primary school children between the ages of 6 to 9 years.
2.Both genders included.
3.Children suffering from habitual mouth breathing syndrome.
|
|
| ExclusionCriteria |
| Details |
1.Children suffering from anatomical obstruction like deviated nasal septum, adenoid hypertrophy, nasal bony spurs, or polyps.
2.Children suffering from cold and cough.
3.Children whose parents did not give consent for the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EtCO2,mirror test, masseler water holding test, lip seal test |
Day zero and end of six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Questionnaire for the recognition & diagnosis of mouth breathing in children |
At the end of six months |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/04/2025 |
| 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="1"
Months="0"
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
|
The purpose of this study is to screen the pediatric population (children between the ages of 6 to 9 years) for children who are habitual mouth breathers. This group of habitual mouth breathers will be further examined by an ENT specialist for any kind of anatomical airway obstruction. This examination will not involve any invasive measures and will be like a short health check-up at school. The group of children diagnosed with habitual mouth breathing and with NO anatomical airway obstruction will be included in the research study with their parent’s written consent. The sole purpose of this study is to identify and diagnose habitual mouth breathing in children and to rectify this habit before the onset of the deleterious effects related to mouth breathing.
|