Washington University in St. Louis
St Louis, Missouri, 63110, United States
NCT Number: NCT06236477
This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.
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Notify Me3 year–9 year
All sexes
Interventional
Phase 1 / Phase 2
St Louis, Missouri, 63110, United States
Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
Participants will receive standard care without music.
Time frame: day of surgery
Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome
Time frame: day of surgery
Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome
Time frame: day of surgery
Pain scale. Range 0-10, higher score indicates a worse outcome
Time frame: day of surgery
Pain scale. Range 0-10, higher score indicates a worse outcome
Time frame: day of surgery
Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome
Time frame: day of surgery
Survey of parental satisfaction with perioperative care. A qualitative survey with discrete questions that contain "yes" or "no" or likert-style ratings ranging from "strongly disagree" to "strongly agree."
Time frame: 1 year
Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome
Washington University School of Medicine
Other
Acronym: DEAP Music
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