Induction in the Dark

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia Induction
• Intervention / Treatment: Other: Dark with star projector; Other: Parental Presence; Drug: Preoperative midazolam

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.; Other: Parental Presence; A parent or guardian will accompany the child into the OR and be present for the start of induction.
Active Comparator: 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.	Other: Parental Presence; A parent or guardian will accompany the child into the OR and be present for the start of induction.; Drug: Preoperative midazolam; Midazolam by mouth preoperatively.
Active Comparator: Parental presence alone; Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.	Other: Parental Presence; A parent or guardian will accompany the child into the OR and be present for the start of induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mask acceptance	Mask acceptance during inhalational mask induction as measured by the mask acceptance scale (MAS). The MAS is scored on a scale from 1-4 by evaluating if the child is calm and accepting of the mask (4), slightly scared but easily calmed (3), has moderate fear of the mask and is not easily calmed (2), or cries, screams, or is terrified (1) during induction when using the inhalation mask. A higher score is better.	during induction evaluated up until the start of the scheduled surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative anxiety	Perioperative anxiety will be measured using the modified Yale perioperative anxiety scale (mYpas) at two different time points; the first will be measured preoperatively in holding, and the other will be measured again during the entry to the operating room. The mYpas consists of 22 items, divided into five categories: activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent. The evaluator will rate the subject in each category (he highest behavioral level observed in each of the five m-YPAS categories is the score for that category), then divide each item rating by the highest possible rating, add all of the produced values, multiply by 100, then divide by 2. The lower the score, the less anxiety the patient is exhibiting.	Measured preoperatively, then measured again during the entry to operating room.
Post-Operative Emergency Delirium	Once in the PACU, the patient will be evaluated for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) Scale. The evaluator will answer 3 questions about the patient's actions on a scale from 0 (extremely) to not at all (1), then an additional 2 questions about restlessness and inconsolable, scored from 0 (not at all) to 4 (extremely. The scores are added up. The total score can range from 0-20, and the lower the score, the better.	from PACU arrival until discharge
Behavioral Changes	At Day 1 Post-Op and again at Day 7 Post Op, a parent or guardian will answer a series of 27 questions that evaluate the child for behavioral changes occurring post-operatively by using the Post-Hospitalization Behavior Questionnaire (PHBQ). The rating scale for this assessment has 5 response options: (1) less than before (2), same as before (3), more than before (4), and much more than before (5). The answerers are added up with a possible range of 27-135. The lower the score, the less behavioral changes have occurred since the procedure.	Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively
Time to PACU discharge	The time in recovery will be measured from time in recovery starts, to time of discharge.	time in recovery, up to 30 days post-op
Parental satisfaction of induction experience	After the induction period of anesthesia is over, the parent or guardian who accompanied the child to the operating room and was present for induction will complete a satisfaction survey. There are 6 questions rated from 1-5 (1 being strongly disagree, and 5 being strongly agree) asking how they felt about the induction experience. There is one question asking about how the parent felt about the child's acceptance of the mask during induction. This is rated from 1 (poor) to 4 (excellent). The scores given for each question are added up. Scores can range from 7-29. The higher the score, the better outcome and higher satisfaction.	evaluated after child's induction is complete up until the end of surgery

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Natalie Barnett, M.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 22, 2026

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anesthetics; Central Nervous System Depressants; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: Pro00132312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No