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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03993080
Other study ID # HEL 2018-008940
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date February 27, 2019

Study information

Verified date June 2019
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 277
Est. completion date February 27, 2019
Est. primary completion date February 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual reality relaxation
1-3.5 minute 360° videos

Locations

Country Name City State
Finland University of Turku Turku

Sponsors (4)

Lead Sponsor Collaborator
University of Turku City of Helsinki, University of Dundee, University of St Andrews

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. immediately after intervention
Secondary 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 immediately after intervention
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