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Behavioral Intervention

Personalized Music Group for Emergence Delirium (DEAP Music Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

DEAP Music Trial Summary

This trial at Washington University in St. Louis is studying the effects of personalized music on children between the ages of 3 and 9 who are undergoing myringotomies. They want to see

Who is the study for?

This trial is for children aged 3-9 who are having ear tube surgery (myringotomies) at Washington University in St. Louis. The study aims to see if listening to personalized music can help prevent confusion or agitation when waking up from anesthesia.Check my eligibility

What is being tested?

The trial is testing the effect of personalized music played during and after surgery against no music, focusing on how it might reduce the chances of kids experiencing emergence delirium—a state of confusion and agitation as they wake up from anesthesia.See study design

What are the potential side effects?

Since this trial involves listening to personalized music, there are no direct medical side effects expected. However, individual responses to music therapy may vary.

DEAP Music Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child, aged 3-9, is scheduled for ear surgery under general anesthesia.

DEAP Music Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pediatric Anesthesia Emergence Delirium Scale

Secondary outcome measures

Face, Legs, Activity, Cry, Consolability scale

Induction Compliance Checklist

Post Hospitalization Behavior Questionnaire

+3 more

DEAP Music Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Personalized Music GroupActive Control1 Intervention

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.

Group II: No Music GroupPlacebo Group1 Intervention

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

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The Society for Pediatric AnesthesiaOTHER

3 Previous Clinical Trials

5,000,173 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,535 Total Patients Enrolled

3 Trials studying Emergence Delirium

611 Patients Enrolled for Emergence Delirium

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 25 and above eligible to participate in this ongoing research study?

"This medical research is seeking participation from individuals who are older than 3 years but younger than 9 years."

Answered by AI

Is this clinical trial currently open for enrollment?

"Based on the information provided by clinicaltrials.gov, this ongoing trial is currently not seeking participants. Although it was initially posted on January 24th, 2024 and recently edited on January 23rd, 2024, there are presently no opportunities for patient enrollment. However, it's worth noting that there are currently 154 other trials actively recruiting patients."

Answered by AI

Which individuals would be considered ideal candidates for participation in this clinical research study?

"To be eligible for this research study, participants must experience emergence delirium and fall within the age range of 3 to 9 years old. The trial aims to recruit approximately 160 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decreasing Emergence Delirium With Personalized Music

Benjamin A Sanofsky 2024. "Decreasing Emergence Delirium With Personalized Music". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236477.