Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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