Virtual Reality to Reduce Anxiety in Adults Having Lower Wisdom Tooth Surgery

NCT07853014 | Recruiting

• 1 other identifier: VR-M3-RCT-2026-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Mandibular Third Molar

Keywords

Virtual Reality; Mandibular Third Molar; Third Molar Surgery; Oral Surgery; State-Trait Anxiety Inventory; Immersive Virtual Reality

Outcome Measures

Primary Outcomes (1)

• State Anxiety During Surgery Measured by the State-Trait Anxiety Inventory-State (STAI-S)

  State anxiety associated with the surgical procedure will be assessed using the 20-item State-Trait Anxiety Inventory-State (STAI-S). The total score ranges from 20 to 80, with higher scores indicating greater state anxiety. Participants will self-complete the STAI-S within 5 minutes after the final suture as the standardized assessment of anxiety associated with the just-completed surgical procedure.

  Within 5 minutes after the final suture on the day of surgery

Secondary Outcomes (2)

• Pain During Surgery Measured by a 0-10 Numeric Rating Scale

  Within 5 minutes after the final suture on the day of surgery

• Immediate Postoperative Satisfaction

  Within 5 minutes after completion of surgery

Study Arms (2)

Immersive Virtual Reality

EXPERIMENTAL

Participants will receive immersive virtual reality using a Meta Quest 3 headset in addition to standardized surgical care during removal of a mandibular third molar

Device: Immersive Virtual Reality (Meta Quest 3)

Standard Care

NO INTERVENTION

Participants will undergo the same standardized mandibular third molar surgical procedure without virtual reality beyond routine care

Interventions

Immersive Virtual Reality (Meta Quest 3) DEVICE

Participants will wear a Meta Quest 3 virtual reality headset with integrated audio displaying relaxing natural scenery. The virtual reality intervention will begin approximately 2-3 minutes before administration of local anesthesia and will continue throughout the surgical procedure until completion of the final suture. The intervention may be discontinued if the participant experiences significant cybersickness, such as dizziness, nausea or discomfort

Immersive Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

School of Dentistry, Hanoi Medical University

Hanoi, Hanoi, Vietnam

RECRUITING

Study Officials

• Van Thang Nguyen, DDS, MSc

  The University of Danang - School of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

• Duc Nguyen Minh, DDS, PhD

  Hanoi Medical University

  STUDY CHAIR

Central Study Contacts

Van Thang Nguyen, DDS, MSc

CONTACT

+84 849999942; drthangvan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and operating surgeons cannot be masked because of the nature of the virtual reality intervention. Outcome assessment staff are masked to treatment allocation. Self-reported questionnaires are completed by participants using standardized instructions and study data are coded to minimize disclosure of treatment allocation during outcome assessment and data handling.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Two-arm parallel-group randomized controlled trial comparing immersive virtual reality plus standard surgical care with standard surgical care alone. Randomization is stratified by baseline STAI-T and uses covariate-adaptive minimization with a biased-coin probability of 0.80/0.20 to balance MDAS, age, and sex.

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)