NCT06236477

Decreasing Emergence Delirium With Personalized Music

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 9 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
BEHAVIORAL	Personalized Music	Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
BEHAVIORAL	No Music	Participants will receive standard care without music.

Timeline

• Start date: 2024-01-26
• Primary completion: 2025-03-28
• Completion: 2026-03-28
• First posted: 2024-02-01
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States