Decreasing Emergence Delirium With Personalized Music (DEAP Music)

This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergence Delirium
• Intervention / Treatment: Behavioral: Personalized Music; Behavioral: No Music

Detailed Description

Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale.

Aim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Child aged 3-9 years
• Presenting for unilateral or bilateral myringotomy under GA

Exclusion Criteria:

• Combined procedures
• Lack of interest in music (e.g., child who does not have musical preferences)
• Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)
• Parent/guardian or patient refusal

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Personalized Music Group; Those assigned to receive music will be asked to provide a short list of 5-10 songs familiar/well-known to the patient (specifically the song title and artist for each song). Songs will be downloaded onto an electronic mp3 player by the research staff member. The mp3 player will then be provided along with a portable Bluetooth speaker for use during the patient's perioperative period, loaded with the songs of their choice.	Behavioral: Personalized Music; Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
Placebo Comparator: No Music Group; Those not assigned to the personalized music group will receive standard care without music.	Behavioral: No Music; Participants will receive standard care without music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Anesthesia Emergence Delirium Scale	Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome	day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The modified Yale Preoperative Anxiety Scale	Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome	day of surgery
Wong-Baker Faces Pain Rating Scale	Pain scale. Range 0-10, higher score indicates a worse outcome	day of surgery
Face, Legs, Activity, Cry, Consolability scale	Pain scale. Range 0-10, higher score indicates a worse outcome	day of surgery
Induction Compliance Checklist	Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome	day of surgery
Satisfaction survey	Survey of parental satisfaction with perioperative care. A qualitative survey with discrete questions that contain "yes" or "no" or likert-style ratings ranging from "strongly disagree" to "strongly agree."	day of surgery
Post Hospitalization Behavior Questionnaire	Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome	1 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: The Society for Pediatric Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Actual): March 28, 2025
• Study Completion (Estimated): March 28, 2026

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Anesthesia; Music; Emergence Delirium; Pediatric Anesthesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: 202309122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No