Is Music the Food of Anesthesia in Children?

Trakya University

Status: Completed

Conditions: Music

Treatments: Device: CEL-480 Sound Level Meter Sonometre; Device: CD player; Device: Earplug; Procedure: Ambient operating room noise

Study type: Interventional

Funder types: Other

Identifiers

NCT03544502

TUTF-GOKAEK (Registry Identifier)

TUTF-GOKAEK 2013/147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

105 participants in 3 patient groups, including a placebo group

Music group

Experimental group

Description:

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

Treatment:

Device: CD player

Device: CEL-480 Sound Level Meter Sonometre

Silence group

Experimental group

Description:

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.

Treatment:

Device: CEL-480 Sound Level Meter Sonometre

Device: Earplug

Noise group

Placebo Comparator group

Description:

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.

Treatment:

Device: CEL-480 Sound Level Meter Sonometre

Procedure: Ambient operating room noise