Decreasing Emergence Delirium With Personalized Music

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 usin...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
160
Inclusion Criteria
  • Child aged 3-9 years
  • Presenting for unilateral or bilateral myringotomy under GA
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
No Music GroupNo MusicThose not assigned to the personalized music group will receive standard care without music.
Personalized Music GroupPersonalized MusicThose 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.
Primary Outcome Measures
NameTimeMethod
Pediatric Anesthesia Emergence Delirium Scaleday of surgery

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

Secondary Outcome Measures
NameTimeMethod
Wong-Baker Faces Pain Rating Scaleday of surgery

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

The modified Yale Preoperative Anxiety Scaleday of surgery

Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome

Satisfaction surveyday 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 Questionnaire1 year

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

Face, Legs, Activity, Cry, Consolability scaleday of surgery

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

Induction Compliance Checklistday 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

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