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Induction in the Dark
Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
Who can join
Ages 2 to 6 · All sexes
Full eligibility criteria
Inclusion Criteria * Age 2 to 6 years old * 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 * History of previous surgery * 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
About the study
This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.
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.
What is being tested
- Dark with star projector (other)
- Preoperative midazolam (drug)
- Parental Presence (other)
Sponsor: Medical University of South Carolina · Participants: 240 · Started: Apr 16, 2024
Contact the study team
- Haley Nitchie, MHA · Phone: 843-792-1869
Official record on ClinicalTrials.gov — NCT06144177
Locations in the U.S.
| South Carolina | Medical University of South Carolina, Charleston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.