Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dental anxiety is a recognised phobia, which involves a fear of going to the dentist and receiving dental treatment. It is very common and can affect people of any age, ranging from a slight fear to a crippling phobia which means that people avoid going to the dentist at all costs. Virtual reality exposure therapy (VRET) is a type of therapy which is commonly used to treat patients with anxiety disorders, such as phobias. The therapy involves using computers to immerse patients in a virtual world, in which they are exposed to sounds and images which trigger their phobia (fear-inducing stimuli). Over time, patients are exposed to stronger stimuli under the supervision of a therapist. This allows the patient to become “used to” the fear-inducing stimuli, so that eventually they stop triggering anxiety. This type of therapy has shown promising results in treating other phobias as it is safer and less expensive than by directly exposing patients to the things that they are scared of (direct confrontation therapy). The aim of this study is to find out whether VRET is an effective way of helping patients who suffer from dental anxiety.

Who can participate?
Adults who have a dental phobia and are in need of dental treatment which will last for less than 30 minutes.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group (intervention group) take part in the VRET. Participants are exposed to five different scenarios, during which their levels of distress are measured every 35 seconds. Each scenario is repeated until it stops causing the participant distress. Those in the second group (control group) are given an information pamphlet, which includes information about dental anxiety and what to expect from a visit to the dentist for a dental procedure. At the start of the study and then again after 1 week, 3 and 6 months, participants take a number of questionnaires in order to find out whether their anxiety levels have changed. Those in the VRET group are also given a questionnaire about their experiences with the virtual reality therapy.

What are the possible benefits and risks of participating?
A benefit of taking part is that participants will be able to learn more about what causes their anxiety which could help to reduce their level of anxiety and stop them from avoiding dental visits in the future. There are very few risks of taking part however the virtual reality therapy may cause simulator sickness (a type of motion sickness) in some participants. Precautions against this will be taken by giving patients regular breaks from the therapy.

Where is the study run from?
Oral Health Centre, SEGi University (Malaysia)

When is the study starting and how long is it expected to run for?
March 2014 to June 2016

Who is funding the study?
ACTA Amsterdam (Netherlands)

Who is the main contact?
Dr Kumar Raghav Gujjar

Trial website

Contact information



Primary contact

Dr Kumar Raghav Gujjar


Contact details

Level 2 Faculty of dentistry
SEGi university
No. 9
Jalan Teknologi
Taman Sains Selangor
Kota Damansara
Petaling Jaya

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Evaluation and comparison of the effectiveness of Virtual Reality Exposure Therapy (VRET) with
an information pamphlet in management of Dental Anxiety patients



Study hypothesis

Virtual Reality Exposure Therapy (VRET) would result in a significantly reduced level of dental anxiety (trait and state anxiety) at 1 week, 3 months and 6 months follow-up compared to the informational pamphlet control group.

Ethics approval

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

Study design

Interventional randomised controlled trial with two study arms and single-centre

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet


Dental anxiety


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.

Intervention type



Drug names

Primary outcome measure

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 measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Oral Health Centre, Faculty of Dentistry, SEGi University
No. 9, Jalan Teknologi Taman Sains Selangor Kota Damansara
Petaling Jaya

Sponsor information


ACTA Amsterdam

Sponsor details

Gustav Mahler Laan 3004

Sponsor type




Funder type


Funder name

ACTA Amsterdam

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Publication of study results in a peer-reviewed journal.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

2016 protocol in:

Publication citations

Additional files

Editorial Notes

24/01/2019: The intention to publish date has been changed from 30/11/2016 to 31/07/2019 29/02/2016: Publication reference added. 25/02/2016: The recruitment end date has been updated from 25/02/2016 to 17/03/2016 and the overall trial end date has been updated from 30/08/2016 to 30/09/2016. In addition, the participant inclusion criteria have been amended to stipulate that participants must meet the DSM-4 diagnostic criteria of dental phobia from the DSM-5 criteria. 29/12/2015: The recruitment end date has been updated from 25/12/2015 to 25/02/2016 and the overall trial end date has been updated from 30/06/2016 to 30/08/2016.