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Completed

NCT Number: NCT04944875

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

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

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Key information

Conditions

Pediatric Solid Tumor Neoplasms Pediatric Brain Tumor Pediatric Cancer

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Özlem Öz Gergin

Kayseri, 38090, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group headphone

Procedure

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.

Group music

Procedure

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.

Group maternal voice

Procedure

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.

Primary outcomes

  1. amount of propofol dose used in sedation

    Time frame: during the MRI procedure

    The total propofol dosage were recorded in during procedure.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2021
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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