Decreasing Emergence Delirium With Personalized Music

NCT06236477 | Active Not Recruiting Phase 1

• 1 other identifier: 202309122
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergence Delirium

Keywords

Anesthesia; Music; Pediatric Anesthesia; Emergence Delirium

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium Scale

  Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome

  day of surgery

Secondary Outcomes (6)

• The modified Yale Preoperative Anxiety Scale

  day of surgery

• Wong-Baker Faces Pain Rating Scale

  day of surgery

• Face, Legs, Activity, Cry, Consolability scale

  day of surgery

• Induction Compliance Checklist

  day of surgery

• Satisfaction survey

  day of surgery

Study Arms (2)

Personalized Music Group

ACTIVE COMPARATOR

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

No Music Group

PLACEBO COMPARATOR

Those not assigned to the personalized music group will receive standard care without music.

Behavioral: No Music

Interventions

Personalized Music BEHAVIORAL

Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care

Personalized Music Group

No Music BEHAVIORAL

Participants will receive standard care without music.

No Music Group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Society for Pediatric Anesthesia: collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: 1:1 parallel-group, superiority randomized controlled trial

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: January 26, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)