Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.

TC Erciyes University

Status: Completed

Conditions: Pediatric Solid Tumor; Pediatric Brain Tumor; Pediatric Cancer

Treatments: Procedure: Group maternal voice; Procedure: Group music; Procedure: Group headphone

Study type: Interventional

Funder types: Other

Identifiers

NCT04944875

2019/266

Details and patient eligibility

About

To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.

Full description

When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment.

Patients were categorized into 3 groups: music, maternal voice and isolation. During the procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music.

All patients were sedated by midazolam and propofol. During the procedure, an additional propofol was administered as required

Enrollment: 210 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA (American Society of Anesthesiologists) I-II

Exclusion criteria

• Patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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210 participants in 3 patient groups

Group I; group headphone

Active Comparator group

Description:

In the first group of the patients in the isolation group wear the headphones but do not listen to music during the procedure. Then patients were sedated by midazolam and propofol.

Treatment:

Procedure: Group headphone

Group II; group music

Active Comparator group

Description:

In the second group of the patients wear the headphones and listen to Vivaldi's The Four Seasons violin concertos by sound isolating headphones during the procedure. Then patients were sedated by midazolam and propofol.

Treatment:

Procedure: Group music

Group III; group maternal voice

Active Comparator group

Description:

In the third group of the patients wear the headphones and listen the maternal voice during the procedure.Then patients were sedated by midazolam and propofol.

Treatment:

Procedure: Group maternal voice