| CTRI Number |
CTRI/2022/11/047414 [Registered on: 18/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of virtual reality and earplug temporal tap technique in reducing gag reflex in pediatric patients |
|
Scientific Title of Study
|
Effectiveness of Virtual Reality and Earplug-Temporal Tap Technique in controlling gag reflex 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 |
Dr Mehek Gandhi |
| Designation |
Post graduate |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune |
| Address |
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9765000465 |
| Fax |
|
| Email |
mehekgandhi18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi Lakade |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune |
| Address |
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9423508535 |
| Fax |
|
| Email |
pedolax@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Lakade |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune |
| Address |
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9423508535 |
| Fax |
|
| Email |
pedolax@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043 |
|
|
Primary Sponsor
|
| Name |
Mehek Gandhi |
| Address |
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043 |
| 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 |
| Dr Mehek Gandhi |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, |
Department of Pediatric and Preventive Dentistry,
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Katraj, Pune-411043
Pune
MAHARASHTRA |
9765000465
mehekgandhi18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
earplug temporal tap technique |
Earplug Temporal-Tap Technique will be used in maxillary impression making to check for gag reduction in pediatric patients. the intervention will be applied for 2 minutes before, during and after impression making. |
| Comparator Agent |
tell-show-do and distraction technique |
normal tell-show-do, leg movements and distraction methods will be applied while making mandibular impressions and control in each patient. |
| Intervention |
Virtual Reality Device |
Virtual Reality Device will be used in maxillary impression making to check for gag reduction in pediatric patients. the intervention will be applied for 2 minutes before, during and after impression making. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with gag severity index score 2 or more on initial examination and diagnostic intervention.
Children who require making of alginate impressions.
|
|
| ExclusionCriteria |
| Details |
Medically compromised children.
Children with gag severity index score less than 2.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in gag reflex recorded using gag prevention index using virtual reality device and earplug temporal tap technique at 0sec, 30sec and 1 min time interval during impression making. |
Recorded in each patient included during the course of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in anxiety level will be recorded using pulse oximeter to measure heart rate and oxygen saturation.
Patients experience will be recorded using faces version of modified child dental anxiety scale. |
Recorded in each patient included during the course of the study. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/11/2022 |
| 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
|
none yet |
|
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 a evaluate distraction technique by virtual reality device and a distraction and acupressure technique by earplug temporal tap technique and their effect on the gag reflex in pediatric patients. The study is a randomized clinical trial on 60 patients to check the effect of virtual reality and earplug temporal tap technique on the reduction in gag reflex as the primary outcome. secondary outcomes involve measurement of reduction in anxiety levels using pulse oximeter and patients experience using faces version of modified child dental anxiety scale. |