| CTRI Number |
CTRI/2023/04/051258 [Registered on: 03/04/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Kaleidoscope and Virtual reality as distraction techniques for reduction of anxiety in young children |
|
Scientific Title of Study
|
Evaluation and comparison of the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children during administration of local anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himani Parakh |
| Designation |
Post Graduate |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department number 302, Pediatric and Preventive Dentistry, SPDC
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8149444744 |
| Fax |
|
| Email |
himaniparakh08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Thosar |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department number 302, Pediatric and Preventive Dentistry, SPDC
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422163632 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himani Parakh |
| Designation |
Post Graduate |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department number 302, Pediatric and Preventive Dentistry, SPDC
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8149444744 |
| Fax |
|
| Email |
himaniparakh08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental College and Hospital, Sawangi (Meghe), Wardha |
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College and Hospital |
| Address |
Department number 302 Pediatric and Preventive Dentistry,SPDC, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha |
| 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 |
| Dr Himani Parakh |
Sharad Pawar Dental College And Hospital |
Department number 302 Pediatric and Preventive Dentistry,SPDC, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA |
8149444744
himaniparakh08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anxious children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional |
Conventional Behavior Management Techniques |
| Intervention |
Kaleidoscope |
effectiveness of kaleidoscope to reduce dental anxiety in young children |
| Comparator Agent |
virtual reality goggles |
effectiveness of virtual reality goggles to reduce dental anxiety in young children |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children from 5 to 8 years of age who are healthy, cooperative but anxious.
2. Children undergoing dental treatment requiring administration of local anesthesia |
|
| ExclusionCriteria |
| Details |
1. Children with known vision problems.
2. Children with psychological abnormalities.
3. Children with special health care needs.
4. Children suffering from systemic diseases.
5. Children and parents unwilling to participate.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Facial Anxiety Scale
Respiratory rate |
Before, during and after intervention at administration of L.A. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulse rate |
Before, during and after intervention at administration of L.A. |
| Oxygen Saturation |
Before, during and after intervention at administration of L.A. |
|
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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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/04/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Anticipation of pain during dental treatment is a frequently reported reason for dental anxiety and fear. Dental anxiety comprises of various physical, mental as well as social components.While in anxious state it is important to shift the child’s attention away from the unpleasant stimuli. Distraction works on the principle of diverting the focus and blocking the reception of the unpleasant stimuli that causes anxiety.Kaleidoscope is being increasingly recognized for its therapeutic and healing value in medical procedures but very few studies on it are available for it’s use in pediatric dentistry.Virtual Reality actively involves children and is an potent tool in helping children to keep their attention away from frightening and painful procedures.Hence the focus of this study, according to the available literature, is to evaluate and compare effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children.AIM: To evaluate and compare the effectiveness of kaleidoscope and virtual reality goggles to reduce dental anxiety in young children undergoing administration of local anesthesia.METHODOLOGY: A Randomized control trial will be done among participants of the age group 5-8 years of age in an isolated setup. The study participants will be given Kaleidoscope, virtual reality and conventional techniques depending on the respected groups. State of anxiety will be scored - pre, during and after local anesthesia administration. EXPECTED RESULTS: Kaleidoscope and Virtual reality goggles will be effective distraction techniques to reduce the anxiety in 5-8 year old children undergoing local anesthesia administration. KEYWORDS: Kaleidoscope, Virtual Reality Goggles, Anxiety, Local Anesthesia.
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