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| Name | Class |
|---|---|
| The Society for Pediatric Anesthesia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Music Group | Active Comparator | 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. |
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| No Music Group | Placebo Comparator | Those not assigned to the personalized music group will receive standard care without music. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Music | Behavioral | Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care |
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| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Anesthesia Emergence Delirium Scale | Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome | day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The modified Yale Preoperative Anxiety Scale | Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome | day of surgery |
| Wong-Baker Faces Pain Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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1:1 parallel-group, superiority randomized controlled trial
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| No Music | Behavioral | Participants will receive standard care without music. |
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Pain scale. Range 0-10, higher score indicates a worse outcome
| day of surgery |
| Face, Legs, Activity, Cry, Consolability scale | Pain scale. Range 0-10, higher score indicates a worse outcome | day of surgery |
| Induction Compliance Checklist | Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome | day of surgery |
| Satisfaction survey | 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." | day of surgery |
| Post Hospitalization Behavior Questionnaire | Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome | 1 year |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |