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Completed

NCT Number: NCT03544502

Is Music the Food of Anesthesia in Children?

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.

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Key information

Conditions

Music

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CD player

Device

CD player opened during anesthesia induction and continued until postoperative 15 minute

Other names: player

CEL-480 Sound Level Meter Sonometre

Device

Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.

Other names: Sonometre

Earplug

Device

the independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.

Ambient operating room noise

Procedure

patients were exposed to the ambient operating room noise.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 1, 2018
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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