Overview
This randomized controlled trial will evaluate whether immersive virtual reality can reduce anxiety in adults undergoing surgical removal of mandibular third molars under local anesthesia. A total of 120 participants will be assigned to either an immersive virtual reality group or a standard-care control group. Participants in the virtual reality group will use a Meta Quest 3 headset displaying relaxing natural scenery beginning 2-3 minutes before local anesthesia and continuing through completion of surgery. Both groups will undergo the same standardized surgical protocol. The primary outcome is state anxiety during surgery, assessed using the State-Trait Anxiety Inventory-State scale (STAI-S). Secondary outcomes include intraoperative pain and immediate postoperative satisfaction. Additional measures will assess postoperative pain, swelling, mouth opening, wound healing, analgesic use, adverse events and acceptability of virtual reality.
Description
This is a single-center, parallel-group randomized controlled trial involving 120 adults scheduled for surgical removal of a mandibular third molar. Eligible participants will be stratified according to baseline trait anxiety (STAI-T \<40 or ≥40). Within each stratum, treatment allocation will use a minimization procedure with a biased-coin probability of 0.80/0.20 to improve balance between groups with respect to dental anxiety measured by the Modified Dental Anxiety Scale, age, and sex. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes.
Participants assigned to the experimental group will use an immersive virtual reality headset (Meta Quest 3) presenting relaxing natural scenery. The headset will be started approximately 2-3 minutes before administration of local anesthesia and will remain in use until completion of the final suture. Participants assigned to the control group will receive standard care without virtual reality.
All mandibular third molar surgeries will follow the same standardized surgical protocol. Participating surgeons will have at least 5 years of surgical experience and will receive protocol-specific training.
State anxiety will be assessed before surgery and immediately after surgery, within 5 minutes after the final suture, with the post-surgical assessment referring to the participant's anxiety experienced during the procedure. Participants will also be followed for postoperative pain, facial swelling, maximum mouth opening, wound healing, sensory disturbances, analgesic consumption, and postoperative complications.
Eligibility
Inclusion Criteria:
Adults aged 18 years or older. Indication for surgical removal of a mandibular third molar. Mandibular third molar with a Pederson difficulty score of 5 or higher on panoramic radiography.
General health status permitting oral surgery, with no current acute infection, swelling or acute pain at the surgical site.
Able and willing to provide written informed consent and comply with the study procedures and scheduled follow-up visits.
Exclusion Criteria:
Severe psychiatric disorder, severe dizziness or a history of significant motion sickness that may interfere with use of virtual reality.
Systemic medical conditions that do not permit surgical treatment, including uncontrolled cardiovascular disease, uncontrolled diabetes mellitus or current use of immunosuppressive medication.
Pregnancy or breastfeeding. Current or previous radiotherapy involving the maxillofacial region.
