The effects of virtual reality exposure therapy (VRET) to treat dental anxiety

ISRCTN ISRCTN25824611
DOI https://doi.org/10.1186/ISRCTN25824611
Secondary identifying numbers N/A
Submission date
17/10/2015
Registration date
26/10/2015
Last edited
27/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Kumar Raghav Gujjar
Public

Level 2 Faculty of dentistry
SEGi university
No. 9, Jalan Teknologi
Taman Sains Selangor
Kota Damansara
Petaling Jaya
47810
Malaysia

ORCiD logoORCID ID 0000-0003-0519-3959

Study information

Study designInterventional randomised controlled trial with two study arms and single-centre
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific titleEvaluation and comparison of the effectiveness of Virtual Reality Exposure Therapy (VRET) with an information pamphlet in management of Dental Anxiety patients
Study acronymVRETDA
Study objectivesVirtual 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(s)SEGi University, Research and Innovation Management Centre Ethics Committee, 22/05/2014, ref: EC01/14-01
Health condition(s) or problem(s) studiedDental anxiety
InterventionThirty 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 typeBehavioural
Primary outcome measureDental 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 measures1. 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 study start date01/03/2014
Completion date30/09/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Total final enrolment30
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment28/10/2015
Date of final enrolment17/03/2016

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Oral Health Centre, Faculty of Dentistry, SEGi University
No. 9, Jalan Teknologi
Taman Sains Selangor
Kota Damansara
Petaling Jaya
47810
Malaysia

Sponsor information

ACTA Amsterdam
Other

Gustav Mahler Laan 3004
Amsterdam
1081
Netherlands

ROR logo "ROR" https://ror.org/04x5wnb75

Funders

Funder type

University/education

ACTA Amsterdam

No information available

Results and Publications

Intention to publish date31/07/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication of study results in a peer-reviewed journal.
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 27/02/2016 Yes No
Results article 01/03/2019 27/10/2022 Yes No

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
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.