Is Music the Food of Anesthesia in Children?

Study Overview
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Brief Summary
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The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise.

Detailed Description
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Hundred and five pediatric patients who scheduled for abdominal surgery in ASA I-II risk groups were enrolled in the study. The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise. The preoperative children's anxiety levels were assessed with the M-YPAS in the operating room. Heart rate (HR) and mid-arterial pressure (MAP) were recorded at 30-minute intervals until the completion of surgery, end of surgery and postoperative. During each measurement, noise level recordings were performed using sonometre. Pediatric Anesthesia Emergence Delirium Score (PEAD) was assessed after extubation, postoperative.

Official Title
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Is Music the Food of Anesthesia in Children?

Conditions
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Music

Intervention / Treatment
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* Device: CD player
* Device: CEL-480 Sound Level Meter Sonometre
* Device: Earplug
* Procedure: Ambient operating room noise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for elective abdominal surgery with an expected operation time of 60 to 120 minutes, were enrolled in the study. Exclusion Criteria: Children were excluded from the study if they had cognitive disorders, with clinically evident hearing impairment, chronic illness, undergoing emergency surgery, and unstable medical conditions requiring intensive care unit admission.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music group<br>Music group (group M, n=35) patients applied CD player. One CDs were prepared with 5 children's songs (classic music) for the study. CD player opened during anesthesia induction and continued until postoperative 15 minute | Device: CD player<br>* CD player opened during anesthesia induction and continued until postoperative 15 minute<br>* Other names: player;Device: CEL-480 Sound Level Meter Sonometre<br>* Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.<br>* Other names: Sonometre;|
| Experimental: Silence group<br>silence group (group S, n=35) patients received the independent anesthesiologist applied earplugs into the patients' ears during anesthesia induction and the earplugs were removed immediately before tracheal tube extubation. During each measurement, noise level recordings were performed using CEL-480 Sound Level Meter Sonometre. | Device: CEL-480 Sound Level Meter Sonometre<br>* Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.<br>* Other names: Sonometre;Device: Earplug<br>* the independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.<br>|
| Placebo Comparator: Noise group<br>noise group (group N, n=35) patients were exposed to the ambient operating room noise. Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium (PAED) Score ≥ 10. | Device: CEL-480 Sound Level Meter Sonometre<br>* Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.<br>* Other names: Sonometre;Procedure: Ambient operating room noise<br>* patients were exposed to the ambient operating room noise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium | Pediatric Anesthesia Emergence Delirium Score was assessed postoperative 15th minutes. | 15 minutes in postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music, anesthesia, surgery