RecruitingPhase 4NCT06144177

Induction in the Dark

Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety


Sponsor

Medical University of South Carolina

Enrollment

240 participants

Start Date

Apr 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether dimming the lights in the operating room during the process of putting a child to sleep with anesthesia helps reduce their anxiety and makes the experience more comfortable. **You may be eligible if...** - Your child is between 2 and 6 years old - They are having an elective (non-emergency) outpatient surgical procedure - They will be given general anesthesia through a face mask - A parent or guardian is willing to be present in the room during the process of going under anesthesia - They have an American Society of Anesthesiologists (ASA) status of I or II (generally healthy or with mild illness) **You may NOT be eligible if...** - Your child has had surgery before - Your child has a fear of the dark - There are medical reasons why mask induction of anesthesia is not appropriate (e.g., drug allergy, ate/drank before surgery, severe acid reflux, active vomiting) - Your child has a severe developmental delay - Your child has extreme pre-existing anxiety - Your child is currently taking psychiatric medications - Your family does not speak English Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERDark 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.

DRUGPreoperative midazolam

Midazolam by mouth preoperatively.

OTHERParental Presence

A parent or guardian will accompany the child into the OR and be present for the start of induction.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06144177


Related Trials