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Clinical Trials/NCT03544502
NCT03544502
Completed
Not Applicable

Is Music the Food of Anesthesia in Children?

Trakya University0 sites105 target enrollmentAugust 28, 2013
ConditionsMusic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Music
Sponsor
Trakya University
Enrollment
105
Primary Endpoint
Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 28, 2013
End Date
August 24, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sevtap Hekimoglu Sahin

Clinical Professor

Trakya University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium

Time Frame: 15 minutes in postoperative

Pediatric Anesthesia Emergence Delirium Score was assessed postoperative 15th minutes.

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