Anxiety Clinical Trial - Assessment of the Impact of Virtual Reality on

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05963750
Study type	Interventional
Source	University Hospital, Caen
Contact
Status	Completed
Phase	N/A
Start date	November 2, 2021
Completion date	July 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia — REVIDEN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms