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Emergence delirium (ED), characterized by disorientation and altered cognitive behavior, is a common postoperative complication in pediatric surgery. It manifests as lack of eye contact with caregivers or parents, aimless kicking and screaming, and inability to be soothed. Auditory stimulation has been shown to reduce the incidence of ED and postoperative pain during emergence following general anesthesia in children. Therefore, this study aimed to investigate the effects of different types of auditory interventions on the incidence of emergence delirium in children undergoing tonsillectomy and/or adenoidectomy under sevoflurane anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M Group | Experimental |
| |
| H Group | Experimental |
| |
| S Group | Experimental |
| |
| C Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Classical Music Group | Other | Repeatedly played Mozart's Lullaby via Bluetooth headphones at 45-60 at 45-60 dB during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of emergence delirium | According to the Pediatric Anesthesia Emergency Delirium Scale (PAED), the occurrence of ED is defined as a PAED score ≥10 at any time during the PACU period (PAED score range: 0-20). | Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of emergence pain | If the Face, Legs, Activity, Cry and Consolability (FLACC) scale ≥ 4 (0 [no pain] ~ 10 [worst pain]), the child was considered to be in pain. | Assess the paediatric anaesthesia emergence delirium (PAED) score at 0, 5, 10, 15, and 30 minutes after the child awakens and the tube is removed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450000 | China |
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Classical Music Group M: Mozart's Lullaby played continuously during surgery via Bluetooth headphones at 45-60 decibels; Group H (Mother's Heartbeat Recording): Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery; Group S (Mother's Lullaby Recording): Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery; Control Group C: No intervention.
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Participants will be randomly assigned to one of four groups (e.g., by coin toss or lottery draw) with a 1:1:1:1 allocation ratio between the experimental and control groups. Neither participants, caregivers, nor outcome assessors will be aware of the group assignment.
| Mother's Heartbeat Recording Group | Other | Repeatedly played recorded mother's heartbeat via Bluetooth headphones at 45-60 dB during surgery |
|
| Mother's Lullaby Recording Group | Other | Repeatedly played recorded mother singing bedtime lullabies via Bluetooth headphones at 45-60 dB during surgery |
|
| Incidence of postoperative adverse events |
Including postoperative nausea and vomiting, excessive secretions, laryngospasm, respiratory depression, bradycardia, hypotension |
| Perioperative |
| PACU Stay Duration | From PACU admission to PACU discharge |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| 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 |
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