| CTRI Number |
CTRI/2024/06/068746 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of distraction using a robotic toy in reducing dental anxiety among young children during the administration of local anesthesia |
|
Scientific Title of Study
|
Evaluation of effectiveness of robot-based distraction in comparison with conventional methods on anxiety and pain perception during local anesthesia administration in pediatric patients: a randomized clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhilasha |
| Designation |
Postgraduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi
College of Dental Sciences and Hospital Cholanagar Hebbal RT
Nagar Post
Bangalore
KARNATAKA
560032
India |
| Phone |
7260056959 |
| Fax |
|
| Email |
abhilasha.dental@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Divya Reddy Cheekolu |
| Designation |
Professor |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi
College of Dental Sciences and Hospital Cholanagar Hebbal RT
Nagar Post
Bangalore
KARNATAKA
560032
India |
| Phone |
9886651419 |
| Fax |
|
| Email |
divyacreddy81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhilasha |
| Designation |
Postgraduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi
College of Dental Sciences and Hospital Cholanagar Hebbal RT
Nagar Post
Bangalore
KARNATAKA
560032
India |
| Phone |
7260056959 |
| Fax |
|
| Email |
abhilasha.dental@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences
and Hospital Cholanagar RT Nagar Post Bangalore Karnataka India 560032 |
|
|
Primary Sponsor
|
| Name |
Abhilasha |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi
College of Dental Sciences and Hospital RGC campus Hebbal R T
Nagar Post Bangalore Karnataka 560032 |
| 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 Abhilasha |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Department of Pediatric
and Preventive
Dentistry RGC campus
cholanagar RT nagar
560032
Bangalore
KARNATAKA |
7260056959
abhilasha.dental@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Sri Rajiv Gandhi College of Dental Sciences and Hospital Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children aged between 4-7 years requiring local anaesthesia for dental treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Behaviour management |
Inferior alveolar nerve block anesthesia will be administered with conventional behaviour management techniques without using any type of distraction aids. The procedure will last roughly about 10 minutes.
|
| Intervention |
Robot-based distraction |
Inferior alveolar nerve block will be administered to the child in presence of a robot toy (MIKO 3), along with routine behaviour management techniques. This is a single visit assessment, requiring no follow-up. The procedure duration lasts roughly about 10-15 minutes, from the time of introduction of the child to robot toy till the completion of local aneshtesia administration. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children of both genders in the age group of 4 to 7 years with no known allergy and/or sensitivity to local anaesthesia.
Children with no previous experience of dental treatment.
Children requiring non-emergency dental treatment under local anesthesia (Inferior alveolar nerve block)
Children of parents willing to give informed consent.
Children categorized under rating 2 or 3 on Frankl behaviour rating scale |
|
| ExclusionCriteria |
| Details |
Children with physical/mental/developmental disorders.
Children with complaints of severe pain requiring emergency treatment.
Children categorized under rating 1 or 4 on Frankl behaviour rating scale |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in dental anxiety experienced by the child during the administration of local anesthesia |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain perception of the child during administration of local anesthesia |
2 minutes |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2024 |
| 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="8"
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 study design involves a two-armed, parallel-group, randomized controlled trial conducted at the Department of Pediatric & Preventive Dentistry, Sri Rajiv Gandhi College of Dental Sciences & Hospital, Bengaluru. Children in the age group of 4-7 years meeting the eligibility criteria will be recruited, and their parents will be provided with an information sheet with a detailed description of the study and requested to give informed consent for participation. The study aims to determine the effectiveness of robot-based distraction in comparison to conventional behaviour management methods in reducing dental anxiety of children during local anesthesia administration. The children will be randomly allocated into two groups: a Control Group receiving conventional behaviour management techniques during local anesthesia administration and an Intervention Group receiving the same standard care along with robot-based distraction. Anxiety will be assessed using the Raghavendra, Madhuri, Sujata Pictorial Scale (RMS-PS) and pulse rate measurements (Physiological measure). The Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used to assess pain during anesthesia administration. Administration of inferior alveolar nerve block will be carried out in all children by a single clinician following a uniform administration protocol. All the observational and physiological measures of anxiety, and pain assessment will be recorded by another investigator not participating in the clinical procedure. Due to the nature of intervention, it will not be possible to blind the investigators, children or parents. The proposed research hypothesis is that the addition of robot-based distraction to conventional behaviour management methods during local anesthesia administration in children will decrease the anxiety and improve pain related behaviour.
|