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Personalized Music for Emergence Agitation

N/A
Recruiting
Led By R J Ramamurthi, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tonsillectomy with or without adenoidectomy
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the post-operative period, usually about 45 minutes
Awards & highlights

Study Summary

This trial will help assess whether personalized music can help decrease EA in pediatric patients.

Who is the study for?
This trial is for children aged 3-9 undergoing specific surgeries like tonsillectomy or myringotomy, who enjoy music. It's not for kids with significant hearing loss, no interest in music, on chronic sedatives or analgesics, having combined procedures not listed, or if they experience surgical complications.Check my eligibility
What is being tested?
The study tests whether personalized music can reduce 'emergence agitation'—confusion and restlessness—as kids wake up from anesthesia after surgery. Half will get their favorite tunes plus usual care; the other half just gets usual care.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, it's important to monitor each child's response to ensure the music is calming and not causing distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had my tonsils removed, with or without adenoid removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the post-operative period, usually about 45 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the post-operative period, usually about 45 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pediatric Anesthesia Emergence Delirium (PAED) scores
Secondary outcome measures
Change in mask acceptances using Induction Compliance Checklist (ICC)
Change in modified Yale Preoperative Anxiety Scale (mYPAS) score
Change in parental satisfaction with the patient's perioperative experience using a post-operative parental satisfaction survey
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized MusicExperimental Treatment1 Intervention
Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit in addition to standard care.
Group II: Standard of CareActive Control1 Intervention
Those assigned to the Standard of Care arm will only receive standard of care in the preoperative holding area as well as in the post-operative care unit

Find a Location

Who is running the clinical trial?

University of Vermont Medical CenterOTHER
41 Previous Clinical Trials
25,725 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,255 Total Patients Enrolled
R J Ramamurthi, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Decreasing Emergence Agitation With Personalized Music
R J Ramamurthi 2021. "Decreasing Emergence Agitation With Personalized Music". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05044832.
~17 spots leftby Nov 2024
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