Is Music the Food of Anesthesia in Children?

Not Applicable

Completed

• Conditions: Music
• Interventions: Device: CEL-480 Sound Level Meter Sonometre; Device: CD player; Device: Earplug; Procedure: Ambient operating room noise

• Registration Number: NCT03544502
• Lead Sponsor: Trakya University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-08-28
• Primary Completion: 2015-08-28
• Study Completion: 2016-08-24
• Study First Submitted: 2018-04-11
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-21
• Last Update Submitted: 2018-05-21
• Study First Posted: 2018-06-01
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Silence group	CEL-480 Sound Level Meter Sonometre	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.
Silence group	Earplug	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.
Noise group	CEL-480 Sound Level Meter Sonometre	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.
Music group	CEL-480 Sound Level Meter Sonometre	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
Noise group	Ambient operating room noise	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.
Music group	CD player	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

Primary Outcome Measures

Name	Time	Method
Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium	15 minutes in postoperative	Pediatric Anesthesia Emergence Delirium Score was assessed postoperative 15th minutes.