Is Music the Food of Anesthesia in Children?

May 21, 2018 updated by: Sevtap Hekimoglu Sahin, Trakya University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Music group
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
Device: CD player
CD player opened during anesthesia induction and continued until postoperative 15 minute
Other Names:
  • player
Device: CEL-480 Sound Level Meter Sonometre
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
Other Names:
  • Sonometre
EXPERIMENTAL: Silence group

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.
Device: CEL-480 Sound Level Meter Sonometre
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
Other Names:
  • Sonometre
Device: Earplug
the independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.
PLACEBO_COMPARATOR: Noise group

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.
Device: CEL-480 Sound Level Meter Sonometre
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
Other Names:
  • Sonometre
Procedure: Ambient operating room noise
patients were exposed to the ambient operating room noise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes in postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2013

Primary Completion (ACTUAL)

August 28, 2015

Study Completion (ACTUAL)

August 24, 2016

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (ACTUAL)

June 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TUTF-GOKAEK 2013/147
  • TUTF-GOKAEK (REGISTRY: Local Ethic)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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