Virtual Reality Relaxation to Decrease Dental Anxiety

June 22, 2019 updated by: Satu Lahti, University of Turku

Virtual Reality Relaxation to Decrease Dental Anxiety in Primary Dental Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20014
        • University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual reality relaxation
Virtual reality relaxation using virtual landscape and audio features and sound
Device: Virtual reality relaxation
1-3.5 minute 360° videos
NO_INTERVENTION: Treatment as usual
Seated in similar environment as experimental group for same time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental anxiety
Time Frame: immediately after intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anticipatory dental anxiety and treatment related dental anxiety
Time Frame: immediately after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

City of Helsinki
University of Dundee
University of St Andrews

Investigators

  • Principal Investigator: Satu Lahti, Department of Community Dentistry, University of Turku, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2018

Primary Completion (ACTUAL)

February 27, 2019

Study Completion (ACTUAL)

February 27, 2019

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (ACTUAL)

June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 22, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEL 2018-008940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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