The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05854329
• Other study ID #: DF CD2313/0024 (P)
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: University of Malaya
• Contact: Leezallini Selvaraj
• Phone: 01127819943
• Email: leezallini[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE)(NIVRE) and Non Immersive Virtual Reality in children having dental anxiety.The main question[s] it aims to answer are: 1. Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with self-reported dental anxiety scale; Malay translated Modified Child Dental Anxiety Scale faces version (MMCDASf)? 2. Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with physiological measure, Pulse Rate(PR)? 3. Is there any difference in dental anxiety measured using MMCDASf and PR between IVRE,NIVRE and control group at pre-test and post-test? 4. What is the correlation between self-reported MMCDASf and physiological measure PR?

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 information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children aged 9-12 years old.
• Children who can understand and complete the MMCDASf 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Behavioral:
• Virtual Reality Exposure
Virtual Reality device using the immersive dental game.

Locations

Country	Name	City	State
Malaysia	Faculty of Dentistry	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MMCDASf score	Malay translated Modified Child Dental Anxiety Scale faces version	10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day
Secondary	Change in Pulse Rate	Will be measured using Pulse Oximeter	10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day