The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children:A Randomised Controlled Trial
NCT ID: NCT05854329
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2023-05-23
2024-03-01
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Virtual Reality Exposure
Virtual Reality device using the immersive dental game.
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.
Virtual Reality Exposure
Virtual Reality device using the immersive dental game.
Control Group
Participants will be waiting for 15 minutes as usual prior to their treatment.
No interventions assigned to this group
Interventions
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Virtual Reality Exposure
Virtual Reality device using the immersive dental game.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
9 Years
12 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Principal Investigators
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Leezallini Selvaraj
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry Medical Ethics Committee (FDMEC)
Locations
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Faculty of Dentistry
Kuala Lumpur, , Malaysia
Countries
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Other Identifiers
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DF CD2313/0024 (P)
Identifier Type: -
Identifier Source: org_study_id
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