Clinical trial NCT06236477: Decreasing Emergence Delirium With Personalized Music
Official title: Decreasing Emergence Delirium With Personalized Music
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Emergence Delirium
Keywords: Anesthesia
Music
Pediatric Anesthesia
Emergence Delirium
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Society for Pediatric Anesthesia
First posted: 2024-02-01
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 parallel-group, superiority randomized controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Child aged 3-9 years
* Presenting for unilateral or bilateral myringotomy under GA

Exclusion Criteria:

* Combined procedures
* 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

Primary outcomes:
measure: Pediatric Anesthesia Emergence Delirium Scale
timeFrame: day of surgery
Secondary outcomes:
measure: The modified Yale Preoperative Anxiety Scale
timeFrame: day of surgery
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: day of surgery
measure: Face, Legs, Activity, Cry, Consolability scale
timeFrame: day of surgery
measure: Induction Compliance Checklist
timeFrame: day of surgery
measure: Satisfaction survey
timeFrame: day of surgery
measure: Post Hospitalization Behavior Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References: