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

Not Applicable

Completed

• Conditions: Pediatric Solid Tumor; Pediatric Brain Tumor; Pediatric Cancer
• Interventions: Procedure: Group headphone; Procedure: Group music; Procedure: Group maternal voice

• Registration Number: NCT04944875
• Lead Sponsor: TC Erciyes University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I; group headphone	Group headphone	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.
Group II; group music	Group music	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.
Group III; group maternal voice	Group maternal voice	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.

Primary Outcome Measures

Name	Time	Method
amount of propofol dose used in sedation	during the MRI procedure	The total propofol dosage were recorded in during procedure.

Trial Locations

Locations (1)

Özlem Öz Gergin; 🇹🇷 Kayseri, Turkey