RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-01-02
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06768021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects within ages 8 to 70.
  2. * Subjects planned for ambulatory intravenous sedation in the oral and maxillofacial surgery clinic.
  3. * Ability to understand verbal English or understand instructions using a sign-language or voice interpreter of their native language.
  1. * Subjects who cannot understand the instructions, even with an interpreter (extremes of age, cognitive impairments, severe psychiatric disease that may affect participation)
  2. * Subjects not undergoing intravenous sedation (oral sedation, nitrous oxide, local anesthesia)
  3. * Subjects undergoing anesthesia in other environments (gastrointestinal suite, operating rooms, interventional radiology)

Contacts and Locations

Study Contact

Omid Akramian, DMD
CONTACT
‭(510) 858-4007‬
oakramian@alamedahealthsystem.org

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Alameda Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-02
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-01-02
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Anesthesia Experience Survey
  • Ambulatory anesthesia
  • Intravenous sedation
  • Guided Visualization
  • Pre-sedation instructions
  • Anesthesia outcomes
  • Oral & Maxillofacial Surgery (OMFS)
  • Face, Legs, Activity, Cry, Consolability (FLACC)

Additional Relevant MeSH Terms

  • Anesthesia Outcomes
  • Anesthesia Complication
  • Anesthesia and Procedure Related Time Intervals
  • Anesthesia Recovery Period
  • Anesthesia, Intravenous
  • Anesthesia Induction