Clinical trial NCT05963750: Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
Official title: Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Avulsion
Anxiety
Keywords: virtual reality
oral surgery
anxiety
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: effectiveness of virtual reality on anxiety (STAI-YA)
timeFrame: Baseline and during the procedure.
measure: effectiveness of virtual reality on anxiety (Visual Analogue Scale)
timeFrame: Baseline and during the procedure.
Secondary outcomes:
measure: Comparability of the results with another metric for assessing anxiety
timeFrame: 1 day of surgery
measure: factors influencing changes in the STAI-YA anxiety score
timeFrame: 1 day of surgery
measure: The wish to renew the virtual reality experience
timeFrame: 1 day of surgery
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
state: Normandie
Study officials:
affiliation: CHU CAEN
name: Alexis Veyssiere, M.D
role: STUDY_DIRECTOR
References: