Tooth AvulsionREVIDENNCT05963750
Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
A study testing virtual reality in people with Tooth Avulsion and Anxiety, run by University Hospital, Caen at 1 site in France.
Trial summary
Fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. Virtual reality (VR) reduces children's pain and anxiety during dental care or oral surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Avulsion, Anxiety
- What is being tested?
- virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2021to 30 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years old) coming for at least two dental extractions under local anesthesia
Who cannot join
- patients suffering of motion sickness,
- claustrophobia,
- uncontrolled epilepsy,
- visual impairment,
- hearing disability,
- non-French speakers,
Show all 10Show fewer
- pregnant women,
- protected adults
- people followed by a psychiatrist whether for depression, bipolarity, schizophrenia
- The day of the intervention, patients who had consumed anxiolytics
Trial locations and contacts
1 site in 1 country.
About this study
Fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. Virtual reality (VR) reduces children's pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a sample of adults during tooth avulsions under local anesthesia. There is a group with virtual reality and a control group without virtual reality.
Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA score before vs during the surgery. Secondary criteria are the relevance of the chosen metric by comparing it to the VAS, defining the factors influencing the evolution of the anxiety score, studying the side effects of VR and the wish to repeat the experience.
Read the detailed description
The virtual reality experience consisted of putting on a headset with music and a 3D helmet on the eyes that broadcast a landscape in motion (a walk).
The inclusion took place in the University Hospital of Caen between november 2021 and may 2022.
119 patients were randomized into two groups, one with VR and another one without VR. At the end, 105 patients were analyzed.
The main objective was to find a reduction in the STAI-YA score of more than 8 points between before and during the intervention. This analysis was performed in both groups.
During the initial consultation, questions were asked about the medical file and informed consent was sought. Patients were then randomised to one of two groups.
During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then the intervention was performed with or without virtual reality, depending on the group, and the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress experienced during the surgery.
- Conditions
- Tooth Avulsion, Anxiety
- Being tested
- virtual reality
- Keywords
- virtual reality, oral surgery, anxiety
- Medical subject headings
- Tooth Avulsion, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
virtual reality
| Study group | Role | What they receive |
|---|---|---|
| virtual reality during the surgery | Experimental | Group with the use of virtual reality during the surgery Receives: Other: virtual reality |
| control | No intervention | Group without the use of virtual reality during the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of virtual reality on anxiety (STAI-YA)
The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.
Measured: Baseline and during the procedure.
effectiveness of virtual reality on anxiety (Visual Analogue Scale)
The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.
Measured: Baseline and during the procedure.
Secondary outcomes (3)
Comparability of the results with another metric for assessing anxiety
The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.
Measured: 1 day of surgery
factors influencing changes in the STAI-YA anxiety score
Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.
Measured: 1 day of surgery
The wish to renew the virtual reality experience
the question "would you like to repeat the experience for other dental avulsions" was asked to the group who had benefited from virtual reality
Measured: 1 day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start2 Nov 2021
- Primary completion30 Apr 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth AvulsionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A list with numbers from 1 to 120 was produced prior to the study on Excel. Each number was assigned a random group (with and without VR). During the first consultation, the patient was assigned a number (the practitioner followed the list on Excel) and therefore a group. Both practitioner and patient knew the patient's group for the next appointment. When the patient filled out the questionnaires, he was referring to his assigned number and not his name. Then, the practitioner filled in the Excel file with the data collected (characteristics of the patients, STAI-YA score, VAS), which were associated with the patient's number, and which were therefore anonymous.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Veyssiere, M.D, Study director, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963750
- Sponsor's protocol ID
- 21-0188
- Acronym
- REVIDEN
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: this is not planned
Publications
Reducing the anxiety of adults during dental avulsions with virtual reality: a randomized controlled trial Anaïs Protin, Hervé Bénateau, Jean-François Sergent, Dorian Henry, Guillaume Gautier and Alexis Veyssière J Oral Med Oral Surg, 30 2 (2024) 12 DOI: https://doi.org/10.1051/mbcb/2024014
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
- ClinicalTrials.gov ID
- NCT05963750
- Acronym / sponsor ID
- REVIDEN / 21-0188
- Conditions
- Tooth Avulsion, Anxiety
- Keywords
- virtual reality, oral surgery, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 27 Jul 2023 (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.
Fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. Virtual reality (VR) reduces children's pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a sample of adults during tooth avulsions under local anesthesia. There is a group with virtual reality and a control group without virtual reality.
Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA score before vs during the surgery. Secondary criteria are the relevance of the chosen metric by comparing it to the VAS, defining the factors influencing the evolution of the anxiety score, studying the side effects of VR and the wish to repeat the experience.
Detailed description
The virtual reality experience consisted of putting on a headset with music and a 3D helmet on the eyes that broadcast a landscape in motion (a walk).
The inclusion took place in the University Hospital of Caen between november 2021 and may 2022.
119 patients were randomized into two groups, one with VR and another one without VR. At the end, 105 patients were analyzed.
The main objective was to find a reduction in the STAI-YA score of more than 8 points between before and during the intervention. This analysis was performed in both groups.
During the initial consultation, questions were asked about the medical file and informed consent was sought. Patients were then randomised to one of two groups.
During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then the intervention was performed with or without virtual reality, depending on the group, and the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress experienced during the surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A list with numbers from 1 to 120 was produced prior to the study on Excel. Each number was assigned a random group (with and without VR). During the first consultation, the patient was assigned a number (the practitioner followed the list on Excel) and therefore a group. Both practitioner and patient knew the patient's group for the next appointment. When the patient filled out the questionnaires, he was referring to his assigned number and not his name. Then, the practitioner filled in the Excel file with the data collected (characteristics of the patients, STAI-YA score, VAS), which were associated with the patient's number, and which were therefore anonymous.
| Arm | Type | Receives |
|---|---|---|
| virtual reality during the surgery | Experimental | Other: virtual realityGroup with the use of virtual reality during the surgery |
| control | No intervention | –Group without the use of virtual reality during the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (> 18 years old) coming for at least two dental extractions under local anesthesia
Key exclusion criteria (10 listed)
- patients suffering of motion sickness,
- claustrophobia,
- uncontrolled epilepsy,
- visual impairment,
- hearing disability,
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 realityvirtual reality | Other | virtual reality during the surgery |
Primary outcome
effectiveness of virtual reality on anxiety (STAI-YA)
Time frame: Baseline and during the procedure.
The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.
effectiveness of virtual reality on anxiety (Visual Analogue Scale)
Time frame: Baseline and during the procedure.
The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.
3 secondary outcomes
Comparability of the results with another metric for assessing anxiety
Time frame: 1 day of surgery
factors influencing changes in the STAI-YA anxiety score
Time frame: 1 day of surgery
The wish to renew the virtual reality experience
Time frame: 1 day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Results publicationReducing the anxiety of adults during dental avulsions with virtual reality: a randomized controlled trial Anaïs Protin, Hervé Bénateau, Jean-François Sergent, Dorian Henry, Guillaume Gautier and Alexis Veyssière J Oral Med Oral Surg, 30 2 (2024) 12 DOI: https://doi.org/10.1051/mbcb/2024014
- Individual participant dataSharing planned: No. this is not planned
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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.
Alexis Veyssiere, M.D study director
University Hospital, Caen
1 site 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 people with Tooth Avulsion and Anxiety, run by University Hospital, Caen at 1 site in France.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of virtual reality on anxiety (STAI-YA) (time frame: Baseline and during the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963750, which also lists 1 linked publication.
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 18 Feb 2026.