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The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children

Primary Purpose

Dental Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Virtual Reality Exposure
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Anxiety

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children aged 9-12 years old. Children who can understand and complete the MMCDASf questionnaire with a score of 19 and above. Children who requires fissure sealants on sound permanent tooth. Exclusion Criteria: Children requiring emergency dental treatment for pain, trauma or facial cellulitis. Children that have undergone invasive dental treatment such as extraction and pulp therapy in the past 6 months. Children with hearing or visual impairment, developmental or intellectual disability, cognitive impairment, balance disorders such as vertigo and cybersickness, sensitivity to the motion or flash light, having accident in the eye, face, neck or arms, history of epileptic seizures, history of cardiac problems Parents who refuse to allow their children to participate in the trial.

Sites / Locations

  • Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Immersive Virtual Reality Exposure

Non Immersive Virtual Reality Exposure

Control Group

Arm Description

Immersive Virtual Reality Dental Game for 15 minutes. Participants will be actively involved with the game, in placing restorations, scaling virtually playing the role of the dentist.

Participants will be made to watch dental related cartoon passively while sitting using the Virtual Reality device for 15 minutes.

Participants will be waiting for 15 minutes as usual prior to their treatment.

Outcomes

Primary Outcome Measures

Change in MMCDASf score
Malay translated Modified Child Dental Anxiety Scale faces version

Secondary Outcome Measures

Change in Pulse Rate
Will be measured using Pulse Oximeter

Full Information

First Posted
April 21, 2023
Last Updated
September 14, 2023
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05854329
Brief Title
The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children
Official Title
The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children: A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE)(NIVRE) and Non Immersive Virtual Reality in children having dental anxiety.The main question[s] it aims to answer are: Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with self-reported dental anxiety scale; Malay translated Modified Child Dental Anxiety Scale faces version (MMCDASf)? Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with physiological measure, Pulse Rate(PR)? Is there any difference in dental anxiety measured using MMCDASf and PR between IVRE,NIVRE and control group at pre-test and post-test? What is the correlation between self-reported MMCDASf and physiological measure PR?
Detailed Description
Participants will be randomised into three groups, Immersive Virtual Reality, Non Immersive Virtual Reality and Control Group.Immersive Virtual Reality group will be asked to play with an immersive virtual reality dental game using Virtual reality device preoperatively after which they will undergo treatment. For the Non Immersive Virtual Reality participants will be asked to watch a dental cartoon using the virtual reality device passively before treatment and the control group of no intervention, to wait as usual before treatment. All groups will undergo dental treatment of resin based fissure sealant placement under cotton roll isolation in one permanent molar.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Immersive and Non immersive Virtual Reality
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immersive Virtual Reality Exposure
Arm Type
Experimental
Arm Description
Immersive Virtual Reality Dental Game for 15 minutes. Participants will be actively involved with the game, in placing restorations, scaling virtually playing the role of the dentist.
Arm Title
Non Immersive Virtual Reality Exposure
Arm Type
Active Comparator
Arm Description
Participants will be made to watch dental related cartoon passively while sitting using the Virtual Reality device for 15 minutes.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will be waiting for 15 minutes as usual prior to their treatment.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure
Intervention Description
Virtual Reality device using the immersive dental game.
Primary Outcome Measure Information:
Title
Change in MMCDASf score
Description
Malay translated Modified Child Dental Anxiety Scale faces version
Time Frame
10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day
Secondary Outcome Measure Information:
Title
Change in Pulse Rate
Description
Will be measured using Pulse Oximeter
Time Frame
10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 9-12 years old. Children who can understand and complete the MMCDASf questionnaire with a score of 19 and above. Children who requires fissure sealants on sound permanent tooth. Exclusion Criteria: Children requiring emergency dental treatment for pain, trauma or facial cellulitis. Children that have undergone invasive dental treatment such as extraction and pulp therapy in the past 6 months. Children with hearing or visual impairment, developmental or intellectual disability, cognitive impairment, balance disorders such as vertigo and cybersickness, sensitivity to the motion or flash light, having accident in the eye, face, neck or arms, history of epileptic seizures, history of cardiac problems Parents who refuse to allow their children to participate in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leezallini Selvaraj
Phone
01127819943
Email
leezallini@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Noorhidayah Zainal Aalam
Phone
0129780364
Email
noorhidayah.zaalam@um.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leezallini Selvaraj
Organizational Affiliation
Faculty of Dentistry Medical Ethics Committee (FDMEC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leezallini Selvaraj
Phone
01123885543
Email
leezallini@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children

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