NCT04942145

Brief Summary

Clinicians should appreciate the effectiveness of virtual reality (VR) headsets for managing both the anxiety and the behaviour of dental patients. The aim of this study was to assess the effectiveness of using a VR headset as a distraction for managing the anxiety and behaviour of patients during their dental treatment related to underlying psychological factors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 10, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

November 3, 2022

Status Verified

July 1, 2022

Enrollment Period

3.4 years

First QC Date

June 10, 2021

Last Update Submit

November 1, 2022

Conditions

Child Behavior ProblemAnxiety, Dental

Keywords

virtual realitydental anxietybehaviourpsychological factors

Outcome Measures

Primary Outcomes (4)

  • Dental anxiety

    MDAS TEST

    3 years

  • Behaviour

    FIS TEST

    3 years

  • Personality traits

    NEOFFI TEST

    3 years

  • coping strategies

    BRIEF COPE INVENTORY

    3 years

Study Arms (2)

Virtual Reality Group

ACTIVE COMPARATOR

With virtual reality. In order to relate the following variables with the effectiveness in reducing dental anxiety.MDAS TEST (Modified Dental Anxiety Scale) FIS TEST (Facial Imagen Scale) Revised Neo Personality Test (NEO-FFI) Brief Cope Inventory, (coping strategies)

Device: virtual reality in dental patients

Control Grooup

EXPERIMENTAL

Without virtual reality. In order to relate the following variables with the effectiveness in reducing dental anxiety.MDAS TEST (Modified Dental Anxiety Scale) FIS TEST (Facial Imagen Scale) Revised Neo Personality Test (NEO-FFI) Brief Cope Inventory, (coping strategies)

Device: virtual reality in dental patients

Interventions

virtual reality in dental patientsDEVICE

The behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied. Participants self-complete the questionnaires

Control GrooupVirtual Reality Group

Eligibility Criteria

Age5 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers with dental needs.
  • Children with parental consent

You may not qualify if:

  • patients with cognitive impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

RECRUITING

Javier Montero

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersBehavior

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
full professor

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 28, 2021

Study Start

January 10, 2018

Primary Completion

June 17, 2021

Study Completion

January 10, 2025

Last Updated

November 3, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)