- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04942145
Effect of Virtual Reality on Dental Patients
November 1, 2022 updated by: JAVIER MONTERO, University of Salamanca
Behaviour, Anxiety Management, Personality Traits and Coping of Dental Patients Through Virtual Reality
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
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
-
-
-
Salamanca, Spain, 37007
- Recruiting
- Javier Montero
-
Contact:
- JAVIER MONTERO, FULL PROFESSOR
- Phone Number: 1996 34 923 294 500
- Email: javimont@usal.es
-
Salamanca, Spain, 37007
- Recruiting
- Clinica Odontológica de la Universidad de Salamanca
-
Contact:
- JAVIER MONTERO, DDS
- Phone Number: 619429971
- Email: javimont@usal.es
-
-
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
5 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers with dental needs.
- Children with parental consent
Exclusion Criteria:
- patients with cognitive impairments
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: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Virtual Reality Group
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)
|
The behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied. Participants self-complete the questionnaires |
|
Experimental: Control Grooup
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)
|
The behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied. Participants self-complete the questionnaires |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental anxiety
Time Frame: 3 years
|
MDAS TEST
|
3 years
|
|
Behaviour
Time Frame: 3 years
|
FIS TEST
|
3 years
|
|
Personality traits
Time Frame: 3 years
|
NEOFFI TEST
|
3 years
|
|
coping strategies
Time Frame: 3 years
|
BRIEF COPE INVENTORY
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 10, 2018
Primary Completion (Actual)
June 17, 2021
Study Completion (Anticipated)
January 10, 2025
Study Registration Dates
First Submitted
June 10, 2021
First Submitted That Met QC Criteria
June 18, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dental virtual reality
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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