Actively Recruiting

Phase Not Applicable
Age: 3Years - 9Years
All Genders
ID05044832

Decreasing Emergence Agitation With Personalized Music in Children Undergoing Elective ENT Procedures

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

100

Participants Needed

2

Research Sites

N/A

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

This research aims to assess how personalized music affects emergence agitation (EA) in children aged 3 to 9 years recovering from elective surgeries under general anesthesia. Emergence agitation is measured using the Pediatric Anesthesia Emergence Delirium (PAED) score, which helps evaluate how children wake up after anesthesia. The study explores if personalized music can reduce anxiety and pain during the perioperative period, potentially improving safety and recovery experiences for both children and caregivers. Participants will be randomly assigned to one of two groups: one receiving personalized music along with standard care, and the other receiving only standard care. The personalized music group will listen to music in the preoperative holding area and the post-operative care unit. All patients will receive a standardized anesthetic depending on their procedure type, with treatments such as oral midazolam, inhalational anesthesia, and pain control medications given as per usual clinical practice. During the study, children will be assessed for emergence delirium through multiple PAED scores taken at 10-minute intervals after surgery. Additional assessments include measuring preoperative anxiety, mask acceptance during anesthesia induction, and post-operative pain using age-appropriate scales. Parents will also be evaluated for anxiety during the procedure and surveyed for satisfaction afterward. Data collection includes clinical records and demographic information, with safety monitored by the principal investigator. Participation typically lasts for the perioperative period until the child is fully awake, about 45 minutes after surgery.

CONDITIONS

Brief Title

Decreasing Emergence Agitation With Personalized Music

Who Can Participate

Age: 3Years - 9Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • Chronic intake 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 that impairs ability to hear music
  • Lack of interest in music reported by parents or inability to identify personally meaningful music

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

Duration - Procedure day plus immediate recovery

Participants undergo elective ENT procedures with general anesthesia and receive either personalized music during the perioperative and post-operative periods or standard care without music.

1 visit (in-person) including preoperative holding area and post-operative care unit assessments

Post-operative Follow-up

Duration - Approximately 45 minutes after procedure until child is fully awake

Participants are assessed post-operatively for emergence agitation, anxiety, mask acceptance, pain, and parental satisfaction during recovery.

Assessment performed during the same visit as treatment

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

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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