Does a Pre-sedation Guided Visualization Exercise Improve Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery: A Double-blinded, Randomized Controlled Trial
| Registry | NCT06768021 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 128 (Actual) |
| Sponsor | Alameda Health System (Other); collaborators: University of California, San Francisco |
| Conditions | Anesthesia Outcomes, Anesthesia Complication, Anesthesia and Procedure Related Time Intervals, Anesthesia Recovery Period, Anesthesia, Intravenous, Anesthesia Induction |
| Interventions | Guided visualization and standardized pre-sedation instructions, Standardized pre-sedation instructions only (Behavioral) |
| Dates | start 2025-01-02, primary completion 2026-04-01, completion 2026-04-01, first posted 2025-01-10, last updated 2026-04-30 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Anesthesia Outcomes All trials for Anesthesia Complication All trials of Guided visualization and standardized pre-sedation instructions All trials of Standardized pre-sedation instructions only
This randomized controlled trial aims to evaluate the impact of a brief guided visualization exercise on anesthesia-related outcomes in oral and maxillofacial surgery in patients scheduled for ambulatory anesthesia in the oral and maxillofacial surgery clinic. Researchers will compare these patients, who will receive the guided visualization exercise in addition to standardized pre-operative instructions, to patients who will only receive the standardized pre-operative instructions. The following outcomes will be measured for both groups:
* A seven-point Anesthesia Experience Survey
* Face-Legs-Activity-Cry-Consolability (FLACC) scores at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded
* Amount of medications used during the sedation
* Length of sedation
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standardized pre-sedation instructions only group | Placebo comparator | Behavioral: Standardized pre-sedation instructions only | This group will receive the standardized pre-sedation instructions only, with no guided visualization. |
| Guided visualization and standardized pre-sedation instructions group | Experimental | Behavioral: Guided visualization and standardized pre-sedation instructions | This arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization. |
Sex: All, ages: 8 Years to 70 Years
Inclusion Criteria: * Subjects within ages 8 to 70. * Subjects planned for ambulatory intravenous sedation in the oral and maxillofacial surgery clinic. * Ability to understand verbal English or understand instructions using a sign-language or voice interpreter of their native language. Exclusion Criteria: * Subjects who cannot understand the instructions, even with an interpreter (extremes of age, cognitive impairments, severe psychiatric disease that may affect participation) * Subjects not undergoing intravenous sedation (oral sedation, nitrous oxide, local anesthesia) * Subjects undergoing anesthesia in other environments (gastrointestinal suite, operating rooms, interventional radiology)
| Facility | City | Country | Status |
|---|---|---|---|
| Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System | Oakland, California | United States |