Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction

NCT ID: NCT07273968

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2027-09-01

Brief Summary

Dental anxiety is common during third molar extractions and may exacerbate pain perception. Local anesthesia does not prevent exposure to stress-inducing stimuli. Virtual reality (VR) combined with hypnotic scripts (HypnoVR®) provides immersive multisensory distraction. This study tests whether VR reduces perioperative anxiety and postoperative pain compared to local anesthesia alone.

Conditions

Dental Anxiety; Third Molar Extraction; Oral Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

Wisdom tooth extraction under local anesthesia with immersive VR hypnosis (HypnoVR® system).

Group Type: EXPERIMENTAL

Virtual reality HypnoVR® (VR headset + hypnotic software)

Intervention Type: DEVICE

CE-marked class I device combining VR immersion with hypnotic text and music therapy to reduce anxiety and pain during oral surgery.

Control Group (No VR)

Wisdom tooth extraction under local anesthesia alone (no VR).

Group Type: ACTIVE_COMPARATOR

Control Group (No VR)

Intervention Type: OTHER

local anesthesia alone (no VR)

Interventions

Virtual reality HypnoVR® (VR headset + hypnotic software)

CE-marked class I device combining VR immersion with hypnotic text and music therapy to reduce anxiety and pain during oral surgery.

Intervention Type: DEVICE

Control Group (No VR)

local anesthesia alone (no VR)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-65
• Indication for extraction of 4 wisdom teeth or ≥2 mandibular wisdom teeth
• ASA I-II
• Written informed consent.

Exclusion Criteria

• Visual/hearing impairment
• Psychiatric disorders or psychotropics (<8 weeks)
• Claustrophobia
• Heavy smoking >10 cig/day
• Previous radiotherapy (jaw)
• ASA III-IV
• Pregnancy
• Antithrombotic therapy
• Chemotherapy
• Bisphosphonates
• Uncontrolled diabetes
• Severe anxiety requiring GA or pharmacological sedation
• No health insurance affiliation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

9832

Identifier Type: -

Identifier Source: org_study_id