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

Caen University Hospital

Status: Completed

Conditions: Tooth Avulsion; Anxiety

Treatments: Other: virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05963750

21-0188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

virtual reality during the surgery

Experimental group

Description:

Group with the use of virtual reality during the surgery

Treatment:

Other: virtual reality

control

No Intervention group

Description:

Group without the use of virtual reality during the surgery