An interventional study of Guided visualization and standardized pre-sedation instructions and Standardized pre-sedation instructions only in Anesthesia Outcomes, Anesthesia Complication and Anesthesia and Procedure Related Time Intervals, sponsored by Alameda Health System. Completed at 1 site in United States. Open to participants aged 8 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Alameda Health System · Not applicable, Interventional, and Supportive care
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:
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's enrollment of 128 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Alameda Health System is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
This group will receive the standardized pre-sedation instructions only, with no guided visualization.
Behavioral: Standardized pre-sedation instructions only
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.
One arm will receive standardized pre-sedation instructions only.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the sedation
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Apr 2026, 14 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 14 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Alameda Health System