Emergence Delirium
Conditions
Keywords
Anesthesia, Music, Pediatric Anesthesia, Emergence Delirium
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.
Interventions
BEHAVIORALPersonalized Music
Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
BEHAVIORALNo Music
Participants will receive standard care without music.
Sponsors
Washington University School of Medicine
The Society for Pediatric Anesthesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
1:1 parallel-group, superiority randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anesthesia Emergence Delirium Scale | day of surgery | Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The modified Yale Preoperative Anxiety Scale | day of surgery | Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome |
| Wong-Baker Faces Pain Rating Scale | day of surgery | Pain scale. Range 0-10, higher score indicates a worse outcome |
| Face, Legs, Activity, Cry, Consolability scale | day of surgery | Pain scale. Range 0-10, higher score indicates a worse outcome |
| Induction Compliance Checklist | day of surgery | Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome |
| Satisfaction survey | 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." |
| Post Hospitalization Behavior Questionnaire | 1 year | Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome |
Countries
United States
Outcome results
None listed