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NCT03544502 Clinical Trial

Is Music the Food of Anesthesia in Children?

Music Clinical Trial

Official title:
Is Music the Food of Anesthesia in Children?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03544502
Other study ID # TUTF-GOKAEK 2013/147
Secondary ID TUTF-GOKAEK
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2013
Est. completion date August 24, 2016

Study information
Verified date May 2018
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date August 24, 2016
Est. primary completion date August 28, 2015
Accepts healthy volunteers No
Gender All
Age group 5 Years to 9 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• CD player
CD player opened during anesthesia induction and continued until postoperative 15 minute
• CEL-480 Sound Level Meter Sonometre
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
• Earplug
the independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.
Procedure:
• Ambient operating room noise
patients were exposed to the ambient operating room noise.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Trakya University

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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