Child Behavior ProblemNCT04942145
Effect of Virtual Reality on Dental Patients
A study testing virtual reality in dental patients in people with Child Behavior Problem and Anxiety, Dental, run by University of Salamanca at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Problem, Anxiety, Dental
- What is being tested?
- virtual reality in dental patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Jan 2018to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers with dental needs.
- Children with parental consent
Who cannot join
- patients with cognitive impairments
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Clinica Odontológica de la Universidad de Salamanca
Salamanca, 37007
JAVIER MONTERO, DDS, 619429971, javimont@usal.es
- Recruiting
Javier Montero
Salamanca, 37007
JAVIER MONTERO, FULL PROFESSOR, 34 923 294 500 ext. 1996, javimont@usal.es
About this study
Official title: 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.
- Conditions
- Child Behavior Problem, Anxiety, Dental
- Being tested
- virtual reality in dental patients
- Keywords
- virtual reality, dental anxiety, behaviour, psychological factors
- Medical subject headings
- Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: virtual reality in dental patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety
MDAS TEST
Measured: 3 years
Behaviour
FIS TEST
Measured: 3 years
Personality traits
NEOFFI TEST
Measured: 3 years
coping strategies
BRIEF COPE INVENTORY
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start10 Jan 2018
- Primary completion17 Jun 2021
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942145
- Sponsor's protocol ID
- Dental virtual reality
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviour, Anxiety Management, Personality Traits and Coping of Dental Patients Through Virtual Reality
- ClinicalTrials.gov ID
- NCT04942145
- Acronym / sponsor ID
- Dental virtual reality
- Conditions
- Child Behavior Problem, Anxiety, Dental
- Keywords
- virtual reality, dental anxiety, behaviour, psychological factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Active comparator | Device: virtual reality in dental patientsWith 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) |
| Control Grooup | Experimental | Device: virtual reality in dental patientsWithout 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) |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers with dental needs.
- Children with parental consent
Key exclusion criteria (1 listed)
- patients with cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality in dental patientsThe behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied. Participants self-complete the questionnaires | Device | Control Grooup, Virtual Reality Group |
Primary outcome
Dental anxiety
Time frame: 3 years
MDAS TEST
Behaviour
Time frame: 3 years
FIS TEST
Personality traits
Time frame: 3 years
NEOFFI TEST
coping strategies
Time frame: 3 years
BRIEF COPE INVENTORY
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in dental patients in people with Child Behavior Problem and Anxiety, Dental, run by University of Salamanca at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental anxiety (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.