Virtual Reality Relaxation to Decrease Dental Anxiety
Primary Purpose
Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Virtual reality relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety focused on measuring dental anxiety, virtual reality
Eligibility Criteria
Inclusion Criteria:
- attending for dental treatment
- consenting
- able to complete Finnish questionnaire without assistance
- age 18 years or older
Exclusion Criteria:
- those not meeting inclusion criteria
Sites / Locations
- University of Turku
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual reality relaxation
Treatment as usual
Arm Description
Virtual reality relaxation using virtual landscape and audio features and sound
Seated in similar environment as experimental group for same time
Outcomes
Primary Outcome Measures
Dental anxiety
post-test measured with Modified Dental Anxiety Scale, The measure has five questions, each with five reply alternatives from not anxious to extremely anxious (on a scale 1-5), MDAS sums up to the total scale (range 5-25) which is used as primary outcome. Higher scores indicate higher dental anxiety.
Secondary Outcome Measures
Anticipatory dental anxiety and treatment related dental anxiety
The secondary outcome variables are post-test scores for the two sub-scales of the MDAS referred to as 'anticipatory' (MDAS items 1 and 2) and 'treatment' dental anxiety (MDAS items 3, 4 and 5). Scales for sum up as anticipatory anxiety (Items 1 and 2: range 2-10) and treatment anxiety (Items 3-5, range 3-15). Higher scores indicate higher dental anxiety
Full Information
NCT ID
NCT03993080
First Posted
June 19, 2019
Last Updated
June 22, 2019
Sponsor
University of Turku
Collaborators
University of St Andrews, University of Dundee, City of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT03993080
Brief Title
Virtual Reality Relaxation to Decrease Dental Anxiety
Official Title
Virtual Reality Relaxation to Decrease Dental Anxiety in Primary Dental Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
February 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
Collaborators
University of St Andrews, University of Dundee, City of Helsinki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to apply short-term virtual reality relaxation to examine if it is effective in reducing pre-operative dental anxiety in primary health care using an RCT.
Detailed Description
Randomized controlled single-center trial with two parallel arms: Virtual Reality Relaxation (VRR) and Treatment As Usual (TAU) in a public oral health care unit. VRR group receiving a 1-3.5 minute 360° video immersing them in peaceful virtual landscape with audio features and sound supporting the relaxing experience. TAU groups remaining seated for 3 minutes in similar setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
dental anxiety, virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled single-center trial with two parallel arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality relaxation
Arm Type
Experimental
Arm Description
Virtual reality relaxation using virtual landscape and audio features and sound
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Seated in similar environment as experimental group for same time
Intervention Type
Device
Intervention Name(s)
Virtual reality relaxation
Intervention Description
1-3.5 minute 360° videos
Primary Outcome Measure Information:
Title
Dental anxiety
Description
post-test measured with Modified Dental Anxiety Scale, The measure has five questions, each with five reply alternatives from not anxious to extremely anxious (on a scale 1-5), MDAS sums up to the total scale (range 5-25) which is used as primary outcome. Higher scores indicate higher dental anxiety.
Time Frame
immediately after intervention
Secondary Outcome Measure Information:
Title
Anticipatory dental anxiety and treatment related dental anxiety
Description
The secondary outcome variables are post-test scores for the two sub-scales of the MDAS referred to as 'anticipatory' (MDAS items 1 and 2) and 'treatment' dental anxiety (MDAS items 3, 4 and 5). Scales for sum up as anticipatory anxiety (Items 1 and 2: range 2-10) and treatment anxiety (Items 3-5, range 3-15). Higher scores indicate higher dental anxiety
Time Frame
immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
attending for dental treatment
consenting
able to complete Finnish questionnaire without assistance
age 18 years or older
Exclusion Criteria:
those not meeting inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satu Lahti
Organizational Affiliation
Department of Community Dentistry, University of Turku, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turku
City
Turku
ZIP/Postal Code
20014
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31962052
Citation
Lahti S, Suominen A, Freeman R, Lahteenoja T, Humphris G. Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial. JDR Clin Trans Res. 2020 Oct;5(4):312-318. doi: 10.1177/2380084420901679. Epub 2020 Jan 21.
Results Reference
derived
Learn more about this trial
Virtual Reality Relaxation to Decrease Dental Anxiety
We'll reach out to this number within 24 hrs