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Clinical Trials/NCT04944875
NCT04944875
Completed
Not Applicable

Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric

TC Erciyes University1 site in 1 country210 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Solid Tumor
Sponsor
TC Erciyes University
Enrollment
210
Locations
1
Primary Endpoint
amount of propofol dose used in sedation
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
May 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Özlem ÖZ GERGİN

Principal Investigator

TC Erciyes University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

amount of propofol dose used in sedation

Time Frame: during the MRI procedure

The total propofol dosage were recorded in during procedure.

Study Sites (1)

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