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Clinical Trials/NCT05854329
NCT05854329
Completed
N/A

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

University of Malaya1 site in 1 country66 target enrollmentMay 23, 2023
ConditionsDental Anxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental Anxiety
Sponsor
University of Malaya
Enrollment
66
Locations
1
Primary Endpoint
Change in Malay-MCDASf score
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2023
End Date
March 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Malay-MCDASf score

Time Frame: 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 Outcomes

  • Change in Pulse Rate(10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day)

Study Sites (1)

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