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

Not Applicable
Completed
Conditions
Dental Anxiety
Interventions
Behavioral: Virtual Reality Exposure
Registration Number
NCT05854329
Lead Sponsor
University of Malaya
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Immersive Virtual Reality ExposureVirtual Reality ExposureImmersive 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.
Non Immersive Virtual Reality ExposureVirtual Reality ExposureParticipants will be made to watch dental related cartoon passively while sitting using the Virtual Reality device for 15 minutes.
Primary Outcome Measures
NameTimeMethod
Change in Malay-MCDASf score10 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
NameTimeMethod
Change in Pulse Rate10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day

Will be measured using Pulse Oximeter

Trial Locations

Locations (1)

Faculty of Dentistry

🇲🇾

Kuala Lumpur, Malaysia

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