Actively Recruiting

Phase Not Applicable
Age: 3Years - 9Years
All Genders
NCT05044832

Decreasing Emergence Agitation With Personalized Music

Led by Stanford University · Updated on 2024-11-22

100

Participants Needed

2

Research Sites

259 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

U

University of Vermont Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of the study is to assess the impact of personalized music on emergence agitation (EA), as measured by Pediatric Anesthesia Emergence Delirium scores in pediatric patients recovering from elective procedures under general anesthesia. Personalized music may help to decrease EA in children undergoing elective surgeries under general anesthesia by decreasing perioperative anxiety and minimizing perceived pain. The study has the potential to improve perioperative care by improving safety, decreasing the need for postoperative pharmacologic and nursing interventions, thereby shortening the time of recovery and improving caregiver satisfaction. Participants participating in this study will be randomly assigned to receive personalized music plus standard of care, or standard of care alone. Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit.

CONDITIONS

Official Title

Decreasing Emergence Agitation With Personalized Music

Who Can Participate

Age: 3Years - 9Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient ages 3 to 9 years
  • Undergoing unilateral or bilateral myringotomy, laser treatment for skin lesions, or adenoidectomy without tonsillectomy
  • Undergoing tonsillectomy with or without adenoidectomy
Not Eligible

You will not qualify if you...

  • Chronic use of any sedative or analgesic medication
  • Combined surgical procedures not listed in inclusion criteria
  • Surgical or anesthetic complications, including use of invasive airway device for myringotomy
  • History of significant hearing loss affecting ability to hear music
  • Lack of interest in music reported by parents or inability to identify personally meaningful music

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

2

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

J

Jyoti Bhamidipati, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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