search
Back to results

Effect of Virtual Reality on Dental Patients

Primary Purpose

Child Behavior Problem, Anxiety, Dental

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
virtual reality in dental patients
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Child Behavior Problem focused on measuring virtual reality, dental anxiety, behaviour, psychological factors

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with cognitive impairments

Sites / Locations

  • Clinica Odontológica de la Universidad de SalamancaRecruiting
  • Javier MonteroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Virtual Reality Group

Control Grooup

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Dental anxiety
MDAS TEST
Behaviour
FIS TEST
Personality traits
NEOFFI TEST
coping strategies
BRIEF COPE INVENTORY

Secondary Outcome Measures

Full Information

First Posted
June 10, 2021
Last Updated
November 1, 2022
Sponsor
University of Salamanca
search

1. Study Identification

Unique Protocol Identification Number
NCT04942145
Brief Title
Effect of Virtual Reality on Dental Patients
Official Title
Behaviour, Anxiety Management, Personality Traits and Coping of Dental Patients Through Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
January 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Problem, Anxiety, Dental
Keywords
virtual reality, dental anxiety, behaviour, psychological factors

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control Grooup
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
virtual reality in dental patients
Intervention Description
The behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied. Participants self-complete the questionnaires
Primary Outcome Measure Information:
Title
Dental anxiety
Description
MDAS TEST
Time Frame
3 years
Title
Behaviour
Description
FIS TEST
Time Frame
3 years
Title
Personality traits
Description
NEOFFI TEST
Time Frame
3 years
Title
coping strategies
Description
BRIEF COPE INVENTORY
Time Frame
3 years

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers with dental needs. Children with parental consent Exclusion Criteria: patients with cognitive impairments
Facility Information:
Facility Name
Clinica Odontológica de la Universidad de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAVIER MONTERO, DDS
Phone
619429971
Email
javimont@usal.es
Facility Name
Javier Montero
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAVIER MONTERO, FULL PROFESSOR
Phone
34 923 294 500
Ext
1996
Email
javimont@usal.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Virtual Reality on Dental Patients

We'll reach out to this number within 24 hrs