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Trial registered on ANZCTR


Registration number
ACTRN12617000446369
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
27/03/2017
Date last updated
27/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Reality Exposure Therapy for the Treatment of Dental Phobia
Scientific title
Virtual Reality Exposure Therapy for the Treatment of Dental Phobia: A Controlled Multiple Baseline Study
Secondary ID [1] 290983 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
ISRCTN25824611

Health condition
Health condition(s) or problem(s) studied:
Dental anxiety 301734 0
Dental phobia 301735 0
Condition category
Condition code
Mental Health 301432 301432 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this group were exposed to five different virtual reality (VR) scenarios sequentially in a pre-determined hierarchy using a head mounted device (HMD) and a heart rate wrist band.
1) Sitting passively on the dental chair (no tools).
2) Inspection of the oral cavity using mouth mirror.
3) Introduction of an injection.
4) Introduction of drill without sound
5) Introduction of drill with sound
VRET was conducted utilizing two networked computers of which the VR-simulator computer (Dell XPS-8700 desktop with 4th Generation Intel Core i7-4790 processor (8M Cache, up to 4.0 GHz) and ASUS NVIDIA GEFORCE GTX 750 TI OC 2GB GDDR5 graphic card) rendered the virtual environment and the other User interface-computer allowed the researcher to control and individualize the VR stimuli presented to the patient. An Oculus development kit 2 HMD (Head Mounted Display) with a resolution of 960X1080 per eye was used to immerse the participants in the VR dental environment. A Mio-link wrist band was used to record the HR of the VRET participants in real-time during therapy.
The entire VR treatment was administered in a single session.
During the exposure session the level of discomfort/distress is assessed using Subjective Units of Distress (SUD) scale every 35 seconds for each scenario. The exposure with each VR scenario was repeated until a SUD score of less than or equal to 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 virtual reality exposure therapy (VRET). Further, the VR experience is evaluated during and following VRET.
Intervention code [1] 296935 0
Treatment: Devices
Intervention code [2] 297181 0
Treatment: Other
Comparator / control treatment
Informational Pamphlet: Standard information such as a description of dental procedures, and postoperative pain management, to help patients overcome their dental anxiety
Control group
Active

Outcomes
Primary outcome [1] 300818 0
Visual analogue scale for anxiety (VAS-A)
Timepoint [1] 300818 0
1st participant in both groups: First baseline at recruitment, weekly baseline measurements for 4 weeks, pre and post intervention measurements in the 5th week, then followup weekly measurements for 9 weeks after intervention. Final followup measurement at 6 months

2nd participant in both groups: Baseline measurements weekly for 5 weeks, pre and post intervention measurements in the 6th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months


3rd participant in both groups: Baseline measurements weekly for 6 weeks, pre and post intervention measurements in the 7th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months


4th Participant in both groups: Baseline measurements weekly for 7 weeks, pre and post intervention measurements in the 8th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months

5th participant in both groups: Baseline measurements weekly for 8 weeks, pre and post intervention measurements in the 9th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months
Primary outcome [2] 300819 0
Modified Dental anxiety scale (MDAS)
Timepoint [2] 300819 0
1st participant in both groups: Baseline measurements weekly for 4 weeks, pre and post intervention measurements in the 5th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months

2nd participant in both groups: Baseline measurements weekly for 5 weeks, pre and post intervention measurements in the 6th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months


3rd participant in both groups: Baseline measurements weekly for 6 weeks, pre and post intervention measurements in the 7th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months


4th Participant in both groups: Baseline measurements weekly for 7 weeks, pre and post intervention measurements in the 8th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months

5th participant in both groups: Baseline measurements weekly for 8 weeks, pre and post intervention measurements in the 9th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months
Primary outcome [3] 300820 0
Dental Fear scale (DFS)
Timepoint [3] 300820 0
1st participant in both groups: Baseline measurements weekly for 4 weeks, pre and post intervention measurements in the 5th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months

2nd participant in both groups: Baseline measurements weekly for 5 weeks, pre and post intervention measurements in the 6th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months


3rd participant in both groups: Baseline measurements weekly for 6 weeks, pre and post intervention measurements in the 7th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months


4th Participant in both groups: Baseline measurements weekly for 7 weeks, pre and post intervention measurements in the 8th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months

5th participant in both groups: Baseline measurements weekly for 8 weeks, pre and post intervention measurements in the 9th week, then followup weekly measurements upto 14th week. Final followup measurement at 6 months
Secondary outcome [1] 330961 0
Secondary outcome: Behavioural Avoidance Test (BAT)
Timepoint [1] 330961 0
Pre and post intervention i.e before and after administering VRET
Secondary outcome [2] 330962 0
Physiological response HR assessed using wrist worn heart rate monitor (Only with VRET)
Timepoint [2] 330962 0
Continuously during intervention
Secondary outcome [3] 330963 0
VR experience measured using the following:
1. Presence measured using an 11-point verbal rating scale (VRS)
2. Realism measured using a 11-point (VRS)
3. Severity of nausea (‘cybersickness’) measured using an 11-point VRS
Timepoint [3] 330963 0
VR experience namely presence, realism and cyber sickness were measured once , just after intervention.

Eligibility
Key inclusion criteria
Avoidance of dental treatment for more than 12 months, MDAS score more than or equal to 15, age between 18 to 60 yr, in need of a dental filling or extraction or both with a planned maximum treatment length of 30 minutes per appointment and satisfying “Phobia Checklist” criteria of dental phobia.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Hearing or visual impairment such as stereoscopy blindness or nystagmus.
- Known mental disorders such as psychosis, post-traumatic stress disorder, developmental or intellectual disability and cognitive impairment.
- Known balance disorders such as vertigo and cybersickness
- Patients with previous history of epileptic seizures.
- Any history of cardiac problems
- Patients who are undergoing, or have undergone, any cognitive behavioral therapy (CBT)-based intervention for dental phobia.
- Language impediment (cannot understand English).
- Patients wearing glasses of greater than plus 3.5 power.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1:1 allocation ratio to either the VRET condition or an informational pamphlet (IP) control condition using a sealed, opaque, sequentially numbered envelopes (SNOSE) allocation concealment method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of random numbers from 1 to 10 were generated. The sealed opaque envelopes were shuffled thoroughly and stacked. The sequence of random numbers numbers so generated were written sequentially on the envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
non-concurrent multiple-baseline design
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Intention to treat analysis.
-group differences in changes over time. Evaluation done using a 2 (pre-treatment vs post-treatment) × 2 (VRET vs IP) repeated measures MANOVA (on VAS-A, MDAS and DFS simultaneously)
-differences in mean dental anxiety scores (VAS-A, MDAS, DFS) between the VRET and IP group at baseline (B0), pre-intervention, post-intervention, and follow-up (6 months) assessed using independent samples t-tests
-Visual analysis for the dependent measures VAS-A, MDAS and DFS prior to, during and after treatment for measuring changes relative to the baseline phase
-BAT scores and steps within the treatment conditions compared using paired samples t-tests

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/03/2015
Date of last participant enrolment
Anticipated
Actual
14/04/2015
Date of last data collection
Anticipated
Actual
16/12/2015
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 8598 0
Malaysia
State/province [1] 8598 0
Selangor

Funding & Sponsors
Funding source category [1] 295395 0
Self funded/Unfunded
Name [1] 295395 0
Kumar Raghav Gujjar
Country [1] 295395 0
Malaysia
Primary sponsor type
University
Name
ACTA Amsterdam
Address
Gustav Mahler Laan 3004
Amsterdam
1081
Netherlands
Country
Netherlands
Secondary sponsor category [1] 294219 0
None
Name [1] 294219 0
NA
Address [1] 294219 0
NA
Country [1] 294219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296730 0
SEGi UNIVERSITY ETHICS COMMITTEE
Ethics committee address [1] 296730 0
Ethics committee country [1] 296730 0
Malaysia
Date submitted for ethics approval [1] 296730 0
Approval date [1] 296730 0
22/05/2014
Ethics approval number [1] 296730 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71914 0
Dr Kumar Raghav Gujjar
Address 71914 0
Faculty of Dentistry, Segi University, 9 Jalan Teknologi, Taman Sains Selangor, PJU 5, Kota Damansara, 47810 Petaling Jaya, Selangor, Malaysia
Country 71914 0
Malaysia
Phone 71914 0
+60129323271
Fax 71914 0
Email 71914 0
drrags80@gmail.com
Contact person for public queries
Name 71915 0
Kumar Raghav Gujjar
Address 71915 0
Faculty of Dentistry, Segi University, 9 Jalan Teknologi, Taman Sains Selangor, PJU 5, Kota Damansara, 47810 Petaling Jaya, Selangor, Malaysia
Country 71915 0
Malaysia
Phone 71915 0
+60129323271
Fax 71915 0
Email 71915 0
drrags80@gmail.com
Contact person for scientific queries
Name 71916 0
Kumar Raghav Gujjar
Address 71916 0
Faculty of Dentistry, Segi University, 9 Jalan Teknologi, Taman Sains Selangor, PJU 5, Kota Damansara, 47810 Petaling Jaya, Selangor, Malaysia
Country 71916 0
Malaysia
Phone 71916 0
+60129323271
Fax 71916 0
Email 71916 0
drrags80@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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