| CTRI Number |
CTRI/2018/10/016188 [Registered on: 29/10/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of the bubble breath exercise on behaviour,anxiety and pain during injection anaesthetic in children: a randomized clinical trial |
|
Scientific Title of Study
|
Effect of a relaxation training exercise on behaviour,anxiety and pain during buccal infiltration anaesthesia in children: a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sowmya Sridhar |
| Designation |
Postgraduate |
| Affiliation |
Manipal College of Dental Sciences,Mangalore |
| Address |
Room No. 5,Department of Paedodontics and Preventive dentistry, Manipal College of Dental Sciences, Lighthouse Hill Road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9900660452 |
| Fax |
|
| Email |
sowsri06@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suprabha BS |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Dental Sciences,Mangalore |
| Address |
Room No. 5,Department of Paedodontics and Preventive dentistry, Manipal College of Dental Sciences, Lighthouse Hill Road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9480655538 |
| Fax |
|
| Email |
sprbhbhat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sowmya Sridhar |
| Designation |
Postgraduate |
| Affiliation |
Manipal College of Dental Sciences,Mangalore |
| Address |
Room No. 5,Department of Paedodontics and Preventive dentistry, Manipal College of Dental Sciences, Lighthouse Hill Road, Hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9900660452 |
| Fax |
|
| Email |
sowsri06@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences,Mangalore |
|
|
Primary Sponsor
|
| Name |
Sowmya Sridhar |
| Address |
Flat #402, Milagres Castle Apartments,Hampankatta,Mangalore-575001. |
| Type of Sponsor |
Other [] |
|
|
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 |
| Sowmya Sridhar |
Manipal College of Dental Sciences, Mangalore |
Room No. 5,Department of Paedodontics and Preventive Dentistry
Dakshina Kannada
KARNATAKA |
9900660452
sowsri06@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MANIPAL COLLEGE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers tested to see whether or not relaxation training exercise is helpful in reducing anxiety and pain perception |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise group |
Relaxation training exercise in the form of "bubble breath exercise" taught |
| Comparator Agent |
No exercise group |
Routine verbal reinforcement while giving infiltration anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children in general good systemic health.
Written informed consent from the parents.
Dental treatment required under maxillary buccal infiltration anaesthesia. |
|
| ExclusionCriteria |
| Details |
History of previous unpleasant dental experience involving local anaesthetic
administration.
Children who present with acute pain or require emergency dental treatment under
local anaesthesia.
Children suffering from any illness requiring special medical care.
Children exhibiting definitely negative behavior(Frankl behavior rating 1) during
dental examination |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Facial image Scale and Pulse oximetry- Anxiety
Frankls behaviour rating scale- behaviour during the injection
Wong-Baker FACES scale and FLACC scale- Pain |
Facial image scale- pre-procedure in the first and second appointment; Behaviour and Pain assessed in second appointment 3 days after first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/05/2017 |
| Date of Study Completion (India) |
10/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The sight and sensation of the anaesthetic needle is the most fear-eliciting stimuli in children receiving dental treatment. Children trained on the bubble breath exercise perceived lesser pain while administering buccal infiltration anaesthesia. There was no significant change in the behaviour and anxiety. |