NCT05854329

Brief Summary

The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE) and Non-Immersive Virtual Reality(NIVRE) andin children having dental anxiety.The main question\[s\] it aims to answer are:

  1. 1.Is there a significant difference in baseline dental anxiety scores, as measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
  2. 2.What is the mean change score in dental anxiety measured using the Malay-MCDASf and PR for IVRE, NIVRE, and control groups after the operative procedure?
  3. 3.Is there a significant difference in mean change score of dental anxiety measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
  4. 4.Is there a significant correlation between the Malay-MCDASf scores (subjective) and PR scores (objective) at preoperative, postoperative, and using the score changes for all groups?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

April 21, 2023

Last Update Submit

January 23, 2025

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

  • Change in Malay-MCDASf score

    Malay translated Modified Child Dental Anxiety Scale faces version

    10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day

Secondary Outcomes (1)

  • Change in Pulse Rate

    10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day

Study Arms (3)

Immersive Virtual Reality Exposure

EXPERIMENTAL

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

Non-Immersive Virtual Reality Exposure

ACTIVE COMPARATOR

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

Behavioral: Virtual Reality Exposure

Control Group

NO INTERVENTION

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

Interventions

Virtual Reality ExposureBEHAVIORAL

Virtual Reality device using the immersive dental game.

Immersive Virtual Reality ExposureNon-Immersive Virtual Reality Exposure

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 9-12 years old.
  • Children who can understand and complete the Malay-MCDASf questionnaire with a score of 19 and above.
  • Children who requires fissure sealants on sound permanent tooth.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

  • Selvaraj L, Yusof ZYM, Zakaria NN, Azizi NZ, Aalam NZ. Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children: A Randomised Controlled Trial. Int J Paediatr Dent. 2025 Dec 22. doi: 10.1111/ipd.70066. Online ahead of print.

    PMID: 41429659DERIVED

MeSH Terms

Interventions

Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Leezallini Selvaraj

    Faculty of Dentistry Medical Ethics Committee (FDMEC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Immersive and Non immersive Virtual Reality
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 11, 2023

Study Start

May 23, 2023

Primary Completion

July 28, 2023

Study Completion

March 1, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)