Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Caen
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- effectiveness of virtual reality on anxiety (STAI-YA)
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
virtual reality during the surgery
Group with the use of virtual reality during the surgery
Intervention: virtual reality (Other)
control
Group without the use of virtual reality during the surgery
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- factors influencing changes in the STAI-YA anxiety score(1 day of surgery)
- Comparability of the results with another metric for assessing anxiety(1 day of surgery)
- The wish to renew the virtual reality experience(1 day of surgery)