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Register:	ISRCTN
Last refreshed on:	7 November 2022
Main ID:	ISRCTN25824611
Date of registration:	26/10/2015
Prospective Registration:	Yes
Primary sponsor:	ACTA Amsterdam
Public title:	The effects of virtual reality exposure therapy (VRET) to treat dental anxiety
Scientific title:	Evaluation and comparison of the effectiveness of Virtual Reality Exposure Therapy (VRET) with an information pamphlet in management of Dental Anxiety patients
Date of first enrolment:	28/10/2015
Target sample size:	30
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN25824611
Study type:	Interventional
Study design:	Interventional randomised controlled trial with two study arms and single-centre (Treatment)
Phase:	Not Applicable

Countries of recruitment
Malaysia

Contacts

Name:	Kumar Raghav Gujjar
Address:	Level 2 Faculty of dentistry SEGi university No. 9, Jalan Teknologi Taman Sains Selangor Kota Damansara 47810 Petaling Jaya Malaysia
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged between 18 and 60 years
2. Patients meeting the DSM-4 diagnostic criteria of dental phobia
3. In need of a dental treatment with a planned maximum treatment length of 30 minutes

Exclusion criteria:
1. Stereoblindness
2. Known other mental disorders such as psychosis, post-traumatic stress disorder, developmental or intellectual disability and cognitive impairment
3. Hearing impairment
4. Visual impairment
5. Nystagmus
6. Known balance disorders such as vertigo and cybersickness
7. Patients with previous history of epileptic seizures
8. Any history of cardiac problems
9. Patients who are undergoing/have undergone any cognitive behavioural therapy (CBT)-based intervention
10. Language impediment (cannot understand English)
11. Patients wearing glasses of greater than plus 3.5 power

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dental anxiety
Mental and Behavioural Disorders
Dental anxiety

Intervention(s)

Thirty participants undergo block randomization so that we have equal distribution of participants in both the groups. In order to preserve the allocation concealment, sealed, opaque, sequentially numbered envelopes (SNOSE) are used. Envelopes will be opened serially (next highest number) only after the participant details (patient unique number, date and patient signature) are entered on the envelope.

VRET group: The participants in this group are exposed to five different VR scenarios sequentially in a pre-determined hierarchy (Idle, Mirror, Syringe, Drill with no sound and Drill with sound). During the exposure session the level of discomfort/distress is assessed using Subjective Units of Distress (SUD) scale every 35 seconds. The exposure with each VR scenario is repeated until a SUD score of =2 is obtained before proceeding to the next scenario. Also, the heart rate is monitored continuously during the exposure to determine the physiological response during VRET. Further, the VR experience is evaluated during and following VRET.

Informational Pamphlet control group: Participants in this group will receive a pamphlet of three pages containing information about dental anxiety. The pamphlet will contain details about the standards of care such as patient comfort, description of dental procedures and postoperative pain management. Also, an opportunity is given to the participants to ask the researcher information about dental anxiety.

Primary Outcome(s)

Dental anxiety measured using Visual Analogue Scale-Anxiety (VAS-A), Modified Dental Anxiety Scale (MDAS) and Dental Fear Survey (DFS) questionnaires at baseline, after the intervention, 1 week, 3 months and 6 months follow-up.

Secondary Outcome(s)

1. Avoidance measured using a behavioral test, consisting of observations and an interview asking participants to rate their level of anxiety from 0-10, before and after intervention
2. Physiological arousal measured by recording the heart rate continuously during the VRET session
3. VR-experience measured with questionnaires (presence, sensation of vomiting, intention to use VR googles in the future and about their intention to revisit dental surgery) immediately after the VRET session

Secondary ID(s)

N/A

Source(s) of Monetary Support

ACTA Amsterdam

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

SEGi University, Research and Innovation Management Centre Ethics Committee, 22/05/2014, ref: EC01/14-01

Results

Results available:	Yes
Date Posted:
Date Completed:	30/09/2016
URL:

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