Is Music the Food of Anesthesia in Children?

NCT ID: NCT03544502

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-28
• Study Completion Date: 2016-08-24

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.

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.

Conditions

Music

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CD player

Intervention Type: DEVICE

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

CEL-480 Sound Level Meter Sonometre

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

CEL-480 Sound Level Meter Sonometre

Intervention Type: DEVICE

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

Earplug

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

CEL-480 Sound Level Meter Sonometre

Intervention Type: DEVICE

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

Ambient operating room noise

Intervention Type: PROCEDURE

patients were exposed to the ambient operating room noise.

Interventions

CD player

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

Intervention Type: DEVICE

CEL-480 Sound Level Meter Sonometre

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

Intervention Type: 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.

Intervention Type: DEVICE

Ambient operating room noise

patients were exposed to the ambient operating room noise.

Intervention Type: PROCEDURE

Other Intervention Names

player; Sonometre

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Sevtap Hekimoglu Sahin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 36474510 (View on PubMed)

Other Identifiers

TUTF-GOKAEK

Identifier Type: REGISTRY

Identifier Source: secondary_id

TUTF-GOKAEK 2013/147

Identifier Type: -

Identifier Source: org_study_id