Does Style of Pre-sedation Instructions Improve Patient Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery?

Does a Pre-sedation Guided Visualization Exercise Improve Outcomes in Ambulatory Anesthesia for Oral and Maxillofacial Surgery: A Double-blinded, Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Intravenous; Anesthesia Induction; Anesthesia Recovery Period; Anesthesia Complication; Anesthesia and Procedure Related Time Intervals; Anesthesia Outcomes
• Intervention / Treatment: Behavioral: Standardized pre-sedation instructions only; Behavioral: Guided visualization and standardized pre-sedation instructions

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94602
      • Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standardized pre-sedation instructions only group; This group will receive the standardized pre-sedation instructions only, with no guided visualization.	Behavioral: Standardized pre-sedation instructions only; One arm will receive standardized pre-sedation instructions only.
Experimental: Guided visualization and standardized pre-sedation instructions group; This arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.	Behavioral: Guided visualization and standardized pre-sedation instructions; One arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia Experience Survey	A seven-point survey given after the patient meets Aldrete score discharge criteria, asking the following: how the patient rates their pre-operative anxiety level (0-10), if the patient has any recall of surgery (0 for none, 1 for a little, 2 for everything), if the patient remembers any pain during surgery (0 for none, 1 for a little, 2 for a lot), if the patient feels any nausea (0 for none, 1 for a little, 2 for a lot, 3 for vomiting), if the patient feels any pain now (0 for none, 1 for a little, 2 for a lot), if the patient feels any itching (0 for none, 1 for a little, 2 for a lot), and how satisfied the patient is overall with the sedation/anesthesia experience (0-10).	Within 2 hours of the completion of surgery
Face-Legs-Activity-Cry-Consolability (FLACC)	Face-Legs-Activity-Cry-Consolability (FLACC) is a behavioral scale primarily designed for scoring postoperative pain in infants and young children, but can also be used to assess intraoperative and postoperative pain in adults undergoing intravenous sedation. The scale gives 0, 1, or 2 points for each of the following: the appearance of the patient's face, the appearance of the patient's legs, the amount of activity, the presence of crying, and the extent of consolability, for a total of 10 points. 0-3 points corresponds to mild pain, 4-6 to moderate pain, and 7-10 to severe pain. The scores will be taken at three points in time during the anesthetic - during local anesthesia, during surgery, and fifteen minutes after surgery has concluded.	During local anesthesia, during surgery, and fifteen minutes after surgery has concluded
Amount of medications used during the sedation	The amount of each medication utilized during the sedation will be documented.	During the sedation
Length of sedation	The length of sedation will be measured, with the start point as the administration of the first sedative medication, and the endpoint as the end of phase I of anesthesia recovery, which will be determined with the Aldrete Scoring System.	During the sedation

Collaborators and Investigators

• Sponsor: Alameda Health System
• Collaborators: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Intravenous sedation; Anesthesia Experience Survey; Ambulatory anesthesia; Guided Visualization; Pre-sedation instructions; Anesthesia outcomes; Oral & Maxillofacial Surgery (OMFS); Face, Legs, Activity, Cry, Consolability (FLACC)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Communication; Nonverbal Communication; Facies; Motor Activity; Crying
• Other Study ID Numbers: IRB24-10151A; 24-42546 (Other Identifier: University of California, San Francisco)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No