RecruitingNot ApplicableNCT06768021

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


Sponsor

Alameda Health System

Enrollment

300 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 8 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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)

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Interventions

BEHAVIORALGuided visualization and standardized pre-sedation instructions

One arm will receive standardized pre-sedation instructions, as well as one-minute guided visualization.

BEHAVIORALStandardized pre-sedation instructions only

One arm will receive standardized pre-sedation instructions only.


Locations(1)

Oral & Maxillofacial Surgery Clinic, Highland Hospital, Alameda Health System

Oakland, California, United States

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NCT06768021


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