Virtual Reality to Reduce Anxiety in Adults Having Lower Wisdom Tooth Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHanoi Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Immersive Virtual Reality (Meta Quest 3)
DeviceParticipants 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Immersive Virtual RealityExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
Within 5 minutes after the final suture on the day of surgerySecondary outcomes
1
Pain During Surgery Measured by a 0-10 Numeric Rating Scale
Pain associated with the just-completed surgical procedure will be self-reported on a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. The assessment will be completed within 5 minutes after the final suture.
Time frame
Within 5 minutes after the final suture on the day of surgery2
Immediate Postoperative Satisfaction
Participant-reported satisfaction with the surgical experience will be assessed using a 0-10 numeric rating scale, with higher scores indicating greater satisfaction.
Time frame
Within 5 minutes after completion of surgerySponsors and contacts
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Source ClinicalTrials.gov