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Is Music the Food of Anesthesia in Children?

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ClinicalTrials.gov Identifier: NCT03544502
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sevtap Hekimoglu Sahin, Trakya University

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.

Condition or disease Intervention/treatment Phase
Music Device: CD player Device: CEL-480 Sound Level Meter Sonometre Device: Earplug Procedure: Ambient operating room noise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Is Music the Food of Anesthesia in Children?
Actual Study Start Date : August 28, 2013
Actual Primary Completion Date : August 28, 2015
Actual Study Completion Date : August 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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 Name: player

Device: CEL-480 Sound Level Meter Sonometre
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
Other Name: 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 Name: 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 Name: Sonometre

Procedure: Ambient operating room noise
patients were exposed to the ambient operating room noise.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   age from 5 to 9 years of age
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Sevtap Hekimoglu Sahin, Clinical Professor, Trakya University
ClinicalTrials.gov Identifier: NCT03544502    
Other Study ID Numbers: TUTF-GOKAEK 2013/147
TUTF-GOKAEK ( Registry Identifier: Local Ethic )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sevtap Hekimoglu Sahin, Trakya University:
music, anesthesia, surgery