Actively Recruiting

Phase 4
Age: 2Years - 6Years
All Genders
NCT06144177

Induction in the Dark

Led by Medical University of South Carolina · Updated on 2025-07-08

240

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Induction in the Dark

Who Can Participate

Age: 2Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 2 to 6 years old
  • Classified as American Society of Anesthesiologists physical status I-II
  • Scheduled for outpatient elective surgical procedures
  • Undergoing general anesthesia
  • Parent or guardian willing to be present during anesthesia induction
Not Eligible

You will not qualify if you...

  • History of previous surgery
  • Fear of the dark
  • Contraindication to inhalational mask induction such as allergy to inhaled medications, NPO violation, active nausea or vomiting, or severe GERD
  • Severe developmental delay
  • Severe obvious preoperative anxiety
  • Current use of psychiatric medications
  • Non-English speaking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

H

Haley Nitchie, MHA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Induction in the Dark | DecenTrialz