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Completed

NCT Number: NCT05854329

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

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?

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Key information

Conditions

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

virtual reality exposure

Behavioral

Virtual Reality device using the immersive dental game.

Primary outcomes

  1. 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

  1. Change in Pulse Rate

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

    Will be measured using Pulse Oximeter

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 11, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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