Decreasing Emergence Delirium With Personalized Music

Washington University School of Medicine394 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

394

Conditions

Emergence Delirium

Interventions

Personalized MusicBEHAVIORAL

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

No MusicBEHAVIORAL

Participants will receive standard care without music.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Washington University in St. Louis

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Pediatric Anesthesia Emergence Delirium Scale

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

Time frame: day of surgery

Secondary Outcomes

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

Time frame: day of surgery

Wong-Baker Faces Pain Rating Scale

Pain scale. Range 0-10, higher score indicates a worse outcome

Time frame: day of surgery

Face, Legs, Activity, Cry, Consolability scale

Pain scale. Range 0-10, higher score indicates a worse outcome

Time frame: day of surgery

Induction Compliance Checklist

Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome

Time frame: 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."

Time frame: day of surgery

Post Hospitalization Behavior Questionnaire

Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome

Time frame: 1 year

Data from ClinicalTrials.gov

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