| CTRI Number |
CTRI/2018/05/014123 [Registered on: 25/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of nervousness Reduction Ability of Different Audiovisual Distraction techniques during Local anaesthetic administration in children |
|
Scientific Title of Study
|
To Evaluate and Compare the effect of Different Audiovisual Distraction Technique in Reducing the Anxiety of Children During LA Administration |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GUNDEEP KAUR MADAN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
Room No. 5
Department of Pedodontics and Preventive Dentistry
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES
NH-58 Delhi Meerut road KADRABAD, MODINAGAR,
DISTT. GHAZIABAD, UP 201201
Room No. 5
Department of Pedodontics and Preventive Dentistry
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES
NH-58 Delhi Meerut road
KADRABAD, MODINAGAR,
DISTT. GHAZIABAD, UP 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9818255226 |
| Fax |
01232224958 |
| Email |
gundeepmadan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ZOHRA JABIN |
| Designation |
READER |
| Affiliation |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
Room No. 5
Department of Pedodontics and Preventive Dentistry
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES
NH-58 Delhi Meerut road KADRABAD, MODINAGAR,
DISTT. GHAZIABAD, UP 201201
Room No. 5
Department of Pedodontics and Preventive Dentistry
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES
NH-58 Delhi Meerut road
KADRABAD, MODINAGAR,
DISTT. GHAZIABAD, UP 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871933858 |
| Fax |
01232224958 |
| Email |
drzohrajabin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GUNDEEP KAUR MADAN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
Room No. 5
Department of Pedodontics and Preventive Dentistry
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES
NH-58 Delhi Meerut road KADRABAD, MODINAGAR,
DISTT. GHAZIABAD, UP 201201
Room No. 5
Department of Pedodontics and Preventive Dentistry
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES
NH-58 Delhi Meerut road
KADRABAD, MODINAGAR,
DISTT. GHAZIABAD, UP 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9818255226 |
| Fax |
01232224958 |
| Email |
gundeepmadan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
| Address |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES,
NH-58 Delhi Meerut Road, Kadrabad Modinagar, UP, 201201 |
| 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 |
| Gundeep Kaur Madan |
INSTITUTE OF DENTAL STUDIES AND TECHNOLOGIES |
Room No. 5 Department of Pedodontics and Preventive Dentistry
Ghaziabad
UTTAR PRADESH |
9818255226
gundeepmadan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
uncooperative children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D VR eyeglasses |
3 Dimensional Virtual Reality Eyeglasses for distraction of child negative behavior in dental office used once in a day per patient and for approx 5 minutes |
| Comparator Agent |
Laptop |
Laptop for distraction of child negative behavior in dental office, used once in a day per patient and for approx. 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having at least two teeth bilaterally requiring the need of LA administration for treatment.
2. Anxious children who are potentially cooperative, children falling under Frankl II and III ,behavior rating scale.
|
|
| ExclusionCriteria |
| Details |
1. Children having mental disability,
2. Children having hearing or vision impairment or motor disability that would interfere with using of audio visual aids
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 3D VR eyeglasses are better distraction for childs negative behavior |
7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2017 |
| Date of Study Completion (India) |
20/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No prior publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was conducted in Institute of Dental Studies and Technolopgies, Department of Pedodontics and Preventive Dentistry. Two audiovisual distraction techniques namely VR eyeglasses and laptop were used to assess the childrens behavior in the dental setting anxious children were taken as participants in the study and their BP, Heart Rate, Oxygen Saturation and anxiety scales were measured before and after LA administration using these two techniques for distraction.the results were put to statistical analysis, VR eyeglasses proved to be better among the both for reducing anxiety among children. |