| CTRI Number |
CTRI/2019/09/021221 [Registered on: 13/09/2019] Trial Registered Prospectively |
| Last Modified On: |
13/09/2019 |
| 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 virtual reality glasses on pain perception and anxiety during dental treatment in 6-8 year old children
|
|
Scientific Title of Study
|
Effect of visual distraction technique on pain perception and anxiety during dental treatment in 6-8 year old children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
N Sridhar |
| Designation |
additional professor |
| Affiliation |
manipal college of dental sciences, manipal |
| Address |
department of pedodontics & preventive dentistry
it is near Kamath circle, MIT
Udupi
KARNATAKA
576104
India |
| Phone |
09886932642 |
| Fax |
|
| Email |
drsri.pedo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Sridhar |
| Designation |
additional professor |
| Affiliation |
manipal college of dental sciences, manipal |
| Address |
department of pedodontics & preventive dentistry
email: drsri.pedo@gmail.com
it is near Kamath circle, MIT
Udupi
KARNATAKA
576104
India |
| Phone |
09886932642 |
| Fax |
|
| Email |
drsri.pedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N Sridhar |
| Designation |
additional professor |
| Affiliation |
manipal college of dental sciences, manipal |
| Address |
department of pedodontics & preventive dentistry
it is near Kamath circle, MIT
Udupi
KARNATAKA
576104
India |
| Phone |
09886932642 |
| Fax |
|
| Email |
drsri.pedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded |
| self. dr. n. sridhar, manipal college of dental sciences, manipal |
|
|
Primary Sponsor
|
| Name |
self spnsored Dr N Sridhar |
| Address |
dept of pedodontics and preventive dentistry, manipal |
| Type of Sponsor |
Other [self funded] |
|
|
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 N Sridhar |
Manipal college of dental sciences, manipal |
department of pedodontics & preventive dentistry
Udupi
KARNATAKA |
9886932642
drsri.pedo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children who come for routine dental treatment |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1) Co-operative children who are willing to participate
2) Children in the age group of 6-8years
3) Children who scored less than 25 on the SCARED Questionnaire.
4) Children with a fair oral hygiene without any serious periodontal disease.
|
|
| ExclusionCriteria |
| Details |
1) Uncooperative children
2) Children who scored greater than 25 on the SCARED Questionnaire are known cases of systemic disease or had any previous medical history
3) Children who had a negative record of behavior
4) children who have extensive carious lesions requiring invasive procedures.
5) Children with visual and auditiory defects,
6) children with epilepsy, children that need to be sedated under general anesthesia
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Pain Perception in patient – Wong Bakers Faces Pain Rating Scale. Time point: After the dental procedure
2) Anxiety level in patient – Faces version of the Modified Child Dental Anxiety Scale. Time point: After the dental procedure
|
outcomes are assessed at baseline after completion of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Oxygen saturation of patient - pulse oximetry. Time period: After every 10 minutes during the dental procedure. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2019 |
| 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
|
not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a single blind randomized controlled trial
that studies the efficacy of immersive distraction techniques by using virtual
reality glasses in controlling pain perception and anxiety in children aged
between 6-8 years of age during the dental treatment. 16 patients requiring
non-invasive dental treatment will be a part of the experimental group while
another 16 patients will be exposed to conventional behavior management
techniques during dental treatment. The pain perception, anxiety and blood oxygen
saturation of both the control and experimental group will be recorded using
Wong Bakers Faces Pain Rating Scale, Faces version of the Modified Child Dental
Anxiety Scale and Pulse oximeter are compared. The study will be conducted over
a period of 6 months at the Department of Pedodontics and Preventive Dentistry,
MCODS, Manipal, India. |