Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
240 participants
INTERVENTIONAL
2024-04-16
2026-06-22
Brief Summary
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1. darkened room and star projector with parental presence;
2. preoperative midazolam 0.5 mg/kg by mouth and parental presence; or
3. parental presence alone.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Darkened room and star projector with parental presence
Subjects assigned to this arm, when in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on. They will also have a parent in the room with them during induction of anesthesia.
Dark with star projector
When in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on.
Parental Presence
A parent or guardian will accompany the child into the OR and be present for the start of induction.
Preoperative midazolam 0.5 mg/kg po and parental presence
Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.
Preoperative midazolam
Midazolam by mouth preoperatively.
Parental Presence
A parent or guardian will accompany the child into the OR and be present for the start of induction.
Parental presence alone
Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.
Parental Presence
A parent or guardian will accompany the child into the OR and be present for the start of induction.
Interventions
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Dark with star projector
When in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on.
Preoperative midazolam
Midazolam by mouth preoperatively.
Parental Presence
A parent or guardian will accompany the child into the OR and be present for the start of induction.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical status I-II
* Outpatient elective surgical procedures
* Undergoing general anesthesia
* Parent or guardian willing to be present during induction
Exclusion Criteria
* Fear of the dark
* Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.
* Severe developmental delay
* Severe obvious, preoperative anxiety
* Patients currently using psychiatric medications
* Non-English speaking
2 Years
6 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Natalie Barnett
Associate Professor-Faculty
Principal Investigators
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Natalie Barnett, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00132312
Identifier Type: -
Identifier Source: org_study_id
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