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

Sponsor
University of Malaya (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05854329
Collaborator
(none)
65
3
13

Study Details

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:

  1. 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)?

  2. Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with physiological measure, Pulse Rate(PR)?

  3. Is there any difference in dental anxiety measured using MMCDASf and PR between IVRE,NIVRE and control group at pre-test and post-test?

  4. What is the correlation between self-reported MMCDASf and physiological measure PR?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Exposure
N/A

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 Glass Ionomer Cement (GIC) fissure sealant placement under cotton roll isolation in one permanent molar.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Immersive and Non immersive Virtual RealityImmersive and Non immersive Virtual Reality
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children: A Randomised Control Trial
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immersive Virtual Reality Exposure

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.

Behavioral: Virtual Reality Exposure
Virtual Reality device using the immersive dental game.

Active Comparator: Non Immersive Virtual Reality Exposure

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

Behavioral: Virtual Reality Exposure
Virtual Reality device using the immersive dental game.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. MMCDASf [10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day]

    Malay translated Modified Child Dental Anxiety Scale faces version

Secondary Outcome Measures

  1. Pulse Rate [10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day]

    Will be measured using Pulse Oximeter

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Malaya

Investigators

  • Principal Investigator: Leezallini Selvaraj, Faculty of Dentistry Medical Ethics Committee (FDMEC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Malaya
ClinicalTrials.gov Identifier:
NCT05854329
Other Study ID Numbers:
  • DF CD2313/0024 (P)
First Posted:
May 11, 2023
Last Update Posted:
May 11, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2023