NCT03993080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

June 19, 2019

Last Update Submit

June 22, 2019

Conditions

Dental Anxiety

Keywords

dental anxietyvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Anticipatory dental anxiety and treatment related dental anxiety

    immediately after intervention

Study Arms (2)

Virtual reality relaxation

EXPERIMENTAL

Virtual reality relaxation using virtual landscape and audio features and sound

Device: Virtual reality relaxation

Treatment as usual

NO INTERVENTION

Seated in similar environment as experimental group for same time

Interventions

Virtual reality relaxationDEVICE

1-3.5 minute 360° videos

Virtual reality relaxation

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • attending for dental treatment
  • consenting
  • able to complete Finnish questionnaire without assistance
  • age 18 years or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, 20014, Finland

Location

Related Publications (1)

  • 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.

    PMID: 31962052DERIVED

Study Officials

  • Satu Lahti

    Department of Community Dentistry, University of Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled single-center trial with two parallel arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Community Dentistry

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 20, 2019

Study Start

October 15, 2018

Primary Completion

February 27, 2019

Study Completion

February 27, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)