Procedural AnxietyNCT06723158
Oral Surgery Virtual Reality Glasses Study
A study testing Virtual reality (VR) glasses with relaxation module in people with Procedural Anxiety and Procedural Pain, run by Boston University at 1 site in United States.
Trial summary
The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses. This study has two primary objectives. 1. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Procedural Anxiety, Procedural Pain
- What is being tested?
- Virtual reality (VR) glasses with relaxation module
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to Dec 2026
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients requiring IV sedation for oral surgery procedure
- Patients able to understand the use of virtual reality glasses and provide informed consent/assent
- Patients classified as American Society of Anesthesiologists (ASA) I or II
- No reported substance use within the previous 24 hours
- No reported excessive alcohol consumption
- Willingness to wear eye protection
- Willingness to use certified interpreters if required
- A legal guardian must accompany minors
Who cannot join
- Patient with hearing aids or severe hearing impairment
- Patient with blindness or significant visual impairment that is not corrected by contact lenses
- Patients with cognitive impairments determined and assessed by the researchers
- Pregnant women or women who could be pregnant based on self reporting
- Patients unable to tolerate virtual reality glasses due to motion sickness or other issues
- Patients with history of seizures or epilepsy per self report
- Patients who cannot tolerate VR glasses due to discomfort or a medical emergency that arises during the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic
Boston, Massachusetts, 02118
Radhika Chigurupati, DMD MS, 617-638-4386, rchiguru@bu.edu
About this study
Official title: Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery
The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses.
This study has two primary objectives.
Read more
- To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.
- To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.
80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).
- Conditions
- Procedural Anxiety, Procedural Pain
- Being tested
- Virtual reality (VR) glasses with relaxation module
- Keywords
- Virtual reality glasses, Non emergent oral surgery, IV sedation, Patient Health Questionnaire (PHQ), Generalized Anxiety Disorder (GAD)
- Medical subject headings
- Pain, Procedural, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality (VR) glasses with relaxation moduleOther
The relaxation module will include immersive video and audio components as a distraction from the medical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Intervention Group | Experimental | Participants randomized to this group will receive VR glasses with a relaxation module (audio, visual) to wear during IV placement, induction of anesthesia, and during the procedure. Receives: Other: Virtual reality (VR) glasses with relaxation module |
| Virtual Reality (VR) Control Group | No intervention | Participants randomized to this group will receive VR glasses without a relaxation module to be worn only as safety glasses, during IV placement, induction of anesthesia, and during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety
Scores from the General Anxiety Disorder-7 (GAD-7) will be used to assess the level of anxiety. It is a 7-item instrument with each item scored from 0=Not at all to 3=Nearly every day. GAD-7 total scores for the can range from 0 to 21 with higher scores suggesting more anxiety. The scores are interpreted as 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, and 15-21: severe anxiety.
Measured: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Level of depression
Scores from the Patient Health Questionnaire (PHQ-9) will be used to assess the level of depression. It is a 9-item depression screening tool with each item scored from 0=Not at all to 3=Nearly every day. Scores can range from 0 to 27, with higher scores suggesting more depression. The scores are interpreted as 0-4: None or minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, and 20-27: Severe depression.
Measured: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Amount of Midazolam used
The amount of this drug used will be abstracted form the medical record of each participant.
Measured: pre-incision, 30 minutes post incision, 60 minutes post incision
Amount of Fentanyl used
The amount of this drug used will be abstracted form the medical record of each participant.
Measured: pre-incision, 30 minutes post incision, 60 minutes post incision
Amount of Propofol used
The amount of this drug used will be abstracted form the medical record of each participant.
Measured: pre-incision, 30 minutes post incision, 60 minutes post incision
Amount of Ketamine used
The amount of this drug used will be abstracted form the medical record of each participant.
Measured: pre-incision, 30 minutes post incision, 60 minutes post incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start18 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized group allocation (1:1 block size of 2 for randomization)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radhika Chigurupati, DMD MS, Principal investigator, Goldman School of Dental Medicine, Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723158
- Sponsor's protocol ID
- H-45038
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2024
- Last updated
- 27 Jul 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery
- ClinicalTrials.gov ID
- NCT06723158
- Acronym / sponsor ID
- H-45038
- Conditions
- Procedural Anxiety, Procedural Pain
- Keywords
- Virtual reality glasses, Non emergent oral surgery, IV sedation, Patient Health Questionnaire (PHQ), Generalized Anxiety Disorder (GAD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses.
This study has two primary objectives.
- To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.
- To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.
80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized group allocation (1:1 block size of 2 for randomization)
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Intervention Group | Experimental | Other: Virtual reality (VR) glasses with relaxation moduleParticipants randomized to this group will receive VR glasses with a relaxation module (audio, visual) to wear during IV placement, induction of anesthesia, and during the procedure. |
| Virtual Reality (VR) Control Group | No intervention | –Participants randomized to this group will receive VR glasses without a relaxation module to be worn only as safety glasses, during IV placement, induction of anesthesia, and during the procedure. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients requiring IV sedation for oral surgery procedure
- Patients able to understand the use of virtual reality glasses and provide informed consent/assent
- Patients classified as American Society of Anesthesiologists (ASA) I or II
- No reported substance use within the previous 24 hours
- No reported excessive alcohol consumption
Key exclusion criteria (7 listed)
- Patient with hearing aids or severe hearing impairment
- Patient with blindness or significant visual impairment that is not corrected by contact lenses
- Patients with cognitive impairments determined and assessed by the researchers
- Pregnant women or women who could be pregnant based on self reporting
- Patients unable to tolerate virtual reality glasses due to motion sickness or other issues
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 |
|---|---|---|
| Virtual reality (VR) glasses with relaxation moduleThe relaxation module will include immersive video and audio components as a distraction from the medical procedures. | Other | Virtual Reality (VR) Intervention Group |
Primary outcome
Level of anxiety
Time frame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Scores from the General Anxiety Disorder-7 (GAD-7) will be used to assess the level of anxiety. It is a 7-item instrument with each item scored from 0=Not at all to 3=Nearly every day. GAD-7 total scores for the can range from 0 to 21 with higher scores suggesting more anxiety. The scores are interpreted as 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, and 15-21: severe anxiety.
Level of depression
Time frame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Scores from the Patient Health Questionnaire (PHQ-9) will be used to assess the level of depression. It is a 9-item depression screening tool with each item scored from 0=Not at all to 3=Nearly every day. Scores can range from 0 to 27, with higher scores suggesting more depression. The scores are interpreted as 0-4: None or minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, and 20-27: Severe depression.
Amount of Midazolam used
Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
Amount of Fentanyl used
Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
Amount of Propofol used
Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
Amount of Ketamine used
Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
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 27 Jul 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.
Radhika Chigurupati, DMD MS principal investigator
Goldman School of Dental Medicine, Oral and Maxillofacial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality (VR) glasses with relaxation module in people with Procedural Anxiety and Procedural Pain, run by Boston University at 1 site in United States.
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 8 inclusion and 7 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 27 Jul 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 United States. 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 Radhika Chigurupati, DMD MS (617-638-4386, rchiguru@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of anxiety (time frame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery). The study lists 6 primary outcomes in all. 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 27 Jul 2026.