Anxiety Clinical Trial
— REVIDENOfficial title:
Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
NCT number | NCT05963750 |
Other study ID # | 21-0188 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2, 2021 |
Est. completion date | July 30, 2022 |
Verified date | July 2023 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 119 |
Est. completion date | July 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (> 18 years old) coming for at least two dental extractions under local anesthesia Exclusion Criteria: - patients suffering of motion sickness, - claustrophobia, - uncontrolled epilepsy, - visual impairment, - hearing disability, - non-French speakers, - pregnant women, - protected adults - people followed by a psychiatrist whether for depression, bipolarity, schizophrenia - The day of the intervention, patients who had consumed anxiolytics |
Country | Name | City | State |
---|---|---|---|
France | CHU Caen | Caen | Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effectiveness of virtual reality on anxiety (STAI-YA) | The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure. | Baseline and during the procedure. | |
Primary | effectiveness of virtual reality on anxiety (Visual Analogue Scale) | The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure. | Baseline and during the procedure. | |
Secondary | 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. | 1 day of surgery | |
Secondary | 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. | 1 day of surgery | |
Secondary | 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 | 1 day of surgery |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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