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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality (VR) glasses with relaxation module | Other | The relaxation module will include immersive video and audio components as a distraction from the medical procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | pre-incision, 30 minutes post incision, 60 minutes post incision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radhika Chigurupati, DMD MS | Contact | 617-638-4386 | rchiguru@bu.edu | |
| Paul Wiley, MS | Contact | 617-638-4386 | pjwile20@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Radhika Chigurupati, DMD MS | Goldman School of Dental Medicine, Oral and Maxillofacial Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic | Recruiting | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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Randomized group allocation (1:1 block size of 2 for randomization)
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| Amount of Ketamine used | The amount of this drug used will be abstracted form the medical record of each participant. | pre-incision, 30 minutes post incision, 60 minutes post incision |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |