Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
160 participants
INTERVENTIONAL
2024-01-26
2026-03-28
Brief Summary
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Detailed Description
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Aim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Personalized Music Group
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.
Personalized Music
Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
No Music Group
Those not assigned to the personalized music group will receive standard care without music.
No Music
Participants will receive standard care without music.
Interventions
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Personalized Music
Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
No Music
Participants will receive standard care without music.
Eligibility Criteria
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Inclusion Criteria
* Presenting for unilateral or bilateral myringotomy under GA
Exclusion Criteria
* Lack of interest in music (e.g., child who does not have musical preferences)
* Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)
* Parent/guardian or patient refusal
3 Years
9 Years
ALL
Yes
Sponsors
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The Society for Pediatric Anesthesia
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Benjamin A Sanofsky
Anesthesiologist
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
Countries
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Other Identifiers
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202309122
Identifier Type: -
Identifier Source: org_study_id
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