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

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

Detailed Description
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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

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

Conditions
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Pediatric Solid Tumor, Pediatric Brain Tumor, Pediatric Cancer

Intervention / Treatment
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* Procedure: Group headphone
* Procedure: Group music
* Procedure: Group maternal voice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I; group headphone<br>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. | Procedure: Group headphone<br>* The patients in the first group wore the headphones but did not listen the music or maternal voice. The standard sedation method was applied to all patients.<br>|
| Active Comparator: Group II; group music<br>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. | Procedure: Group music<br>* The patients in the second group listened to classical music (Vivaldi's The Four Seasons violin concertos) by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.<br>|
| Active Comparator: Group III; group maternal voice<br>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. | Procedure: Group maternal voice<br>* The patients in the third group listened to maternal voice by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of propofol dose used in sedation | The total propofol dosage were recorded in during procedure. | during the MRI procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance, sedation, maternal voice, sedative effects