Decreasing Emergence Delirium With Personalized Music

Phase 1

Recruiting

• Conditions: Emergence Delirium

• Registration Number: NCT06236477
• Lead Sponsor: Washington University School of Medicine

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.

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 Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study Start: 2024-01-26
• Status Verified: 2024-02
• Study First Posted: 2024-02-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Wong-Baker Faces Pain Rating Scale	day of surgery	Pain scale. Range 0-10, higher score indicates a worse outcome
The modified Yale Preoperative Anxiety Scale	day of surgery	Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome
Satisfaction survey	day of surgery	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."
Post Hospitalization Behavior Questionnaire	1 year	Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome
Face, Legs, Activity, Cry, Consolability scale	day of surgery	Pain scale. Range 0-10, higher score indicates a worse outcome
Induction Compliance Checklist	day of surgery	Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States