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
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
|
CD player opened during anesthesia induction and continued until postoperative 15 minute
Other Names:
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
Other Names:
|
|
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. |
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
Other Names:
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. |
Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
Other Names:
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
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.