Skip to content

The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children:A Randomised Controlled Trial

The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children: a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05854329
Enrollment
66
Registered
2023-05-11
Start date
2023-05-23
Completion date
2024-03-01
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

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. 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. 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. 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. 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?

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.

Interventions

Virtual Reality device using the immersive dental game.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Immersive and Non immersive Virtual Reality

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Malay-MCDASf score10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same dayMalay translated Modified Child Dental Anxiety Scale faces version

Secondary

MeasureTime frameDescription
Change in Pulse Rate10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same dayWill be measured using Pulse Oximeter

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026