NCT03544502

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

April 11, 2018

Last Update Submit

May 21, 2018

Conditions

Music

Keywords

music, anesthesia, surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Music group

EXPERIMENTAL

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 playerDevice: CEL-480 Sound Level Meter Sonometre

Silence group

EXPERIMENTAL

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 SonometreDevice: Earplug

Noise group

PLACEBO COMPARATOR

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 SonometreProcedure: Ambient operating room noise

Interventions

CD playerDEVICE

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

Also known as: player
Music group
CEL-480 Sound Level Meter SonometreDEVICE

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

Also known as: Sonometre
Music groupNoise groupSilence group
EarplugDEVICE

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

Silence group
Ambient operating room noisePROCEDURE

patients were exposed to the ambient operating room noise.

Noise group

Eligibility Criteria

Age5 Years - 9 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsage from 5 to 9 years of age
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • scheduled for elective abdominal surgery with an expected operation time of 60 to 120 minutes, were enrolled in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hekimoglu Sahin S, Duran R, Basaran UN, Sut N, Colak A, Duran S. Is music the food of the anesthesia in children? World J Pediatr Surg. 2022 Mar 1;5(2):e000328. doi: 10.1136/wjps-2021-000328. eCollection 2022.

    PMID: 36474510DERIVED

MeSH Terms

Interventions

Ear Protective Devices

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesProtective ClothingClothingManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 11, 2018

First Posted

June 1, 2018

Study Start

August 28, 2013

Primary Completion

August 28, 2015

Study Completion

August 24, 2016

Last Updated

June 1, 2018

Record last verified: 2018-05