Dental AnxietyNCT07853014
Virtual Reality to Reduce Anxiety in Adults Having Lower Wisdom Tooth Surgery
A study testing Immersive Virtual Reality (Meta Quest 3) in people with Dental Anxiety and Mandibular Third Molar, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety, Mandibular Third Molar
- What is being tested?
- Immersive Virtual Reality (Meta Quest 3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Jun 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
School of Dentistry, Hanoi Medical University
Hanoi, Hanoi
Van Thang Nguyen, DDS, MSc, +84 849999942, drthangvan@gmail.com
About this study
Official title: Effect of Immersive Virtual Reality on Anxiety During Surgical Removal of Mandibular Third Molars in Adults: A Randomized Controlled 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.
Read the detailed 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.
- Conditions
- Dental Anxiety, Mandibular Third Molar
- Being tested
- Immersive Virtual Reality (Meta Quest 3)
- Keywords
- Virtual Reality, Mandibular Third Molar, Third Molar Surgery, Oral Surgery, State-Trait Anxiety Inventory, Immersive Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Within 5 minutes after the final suture on the day of surgery
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.
Measured: Within 5 minutes after completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start9 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUC NGUYEN MINH, Hanoi Medical University
- Investigators
- Van Thang Nguyen, DDS, MSc, Principal investigator, The University of Danang - School of Medicine and PharmacyDuc Nguyen Minh, DDS, PhD, Study chair, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853014
- Sponsor's protocol ID
- VR-M3-RCT-2026-01
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality on Anxiety During Surgical Removal of Mandibular Third Molars in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07853014
- Acronym / sponsor ID
- VR-M3-RCT-2026-01
- Conditions
- Dental Anxiety, Mandibular Third Molar
- Keywords
- Virtual Reality, Mandibular Third Molar, Third Molar Surgery, Oral Surgery, State-Trait Anxiety Inventory, Immersive Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality | Experimental | Device: Immersive Virtual Reality (Meta Quest 3)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 |
| Standard Care | No intervention | –Participants will undergo the same standardized mandibular third molar surgical procedure without virtual reality beyond routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality (Meta Quest 3)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 | Device | Immersive Virtual Reality |
Primary outcome
State Anxiety During Surgery Measured by the State-Trait Anxiety Inventory-State (STAI-S)
Time frame: Within 5 minutes after the final suture on the day of surgery
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.
2 secondary outcomes
Pain During Surgery Measured by a 0-10 Numeric Rating Scale
Time frame: Within 5 minutes after the final suture on the day of surgery
Immediate Postoperative Satisfaction
Time frame: Within 5 minutes after completion of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Van Thang Nguyen, DDS, MSc principal investigator
The University of Danang - School of Medicine and Pharmacy
Duc Nguyen Minh, DDS, PhD study chair
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality (Meta Quest 3) in people with Dental Anxiety and Mandibular Third Molar, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Van Thang Nguyen, DDS, MSc (+84 849999942, drthangvan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety During Surgery Measured by the State-Trait Anxiety Inventory-State (STAI-S) (time frame: Within 5 minutes after the final suture on the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.