An interventional study of Virtual reality (VR) glasses with relaxation module in Procedural Anxiety and Procedural Pain, sponsored by Boston University. Recruiting at 1 site in United States. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Boston University · Not applicable, Interventional, and Prevention
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.
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).
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 80 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Virtual reality (VR) glasses with relaxation module
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.
The relaxation module will include immersive video and audio components as a distraction from the medical procedures.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2026, 13 months after the start.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 13 months is above that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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