Clinical Trials Directory

Trials / Completed

CompletedNCT03544502

Is Music the Food of Anesthesia in Children?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
105 (actual)
Sponsor
Trakya University · Academic / Other
Sex
All
Age
5 Years – 9 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICECD playerCD player opened during anesthesia induction and continued until postoperative 15 minute
DEVICECEL-480 Sound Level Meter SonometreNoise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
DEVICEEarplugthe independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.
PROCEDUREAmbient operating room noisepatients were exposed to the ambient operating room noise.

Timeline

Start date
2013-08-28
Primary completion
2015-08-28
Completion
2016-08-24
First posted
2018-06-01
Last updated
2018-06-01

Source: ClinicalTrials.gov record NCT03544502. Inclusion in this directory is not an endorsement.