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Recruiting NCT07325331

Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

Trial Parameters

Condition Pediatric Sedation
Sponsor Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 6 Months
Max Age 12 Years
Start Date 2026-01-08
Completion 2026-02-15
Interventions
Silent HeadphoneWhite NoiseLullaby Music

Brief Summary

This prospective randomized study aims to evaluate the effects of three auditory conditions-lullaby music, white noise, and silent headphone use-on sedation depth, anesthetic drug requirements, and recovery outcomes in children undergoing MRI. A total of 150 pediatric patients aged 6 months to 12 years will be assigned to one of three groups: lullaby, white noise, or silent headphone (isolation) control. All participants will receive routine sedoanalgesia according to institutional protocol. Vital signs, sedation depth, movement requiring sequence repetition, additional anesthetic dosing, and intra-procedural complications will be recorded. Post-procedure recovery will be assessed using the Ramsey Sedation Scale and the Modified Aldrete Score until discharge criteria are met. The study will compare whether auditory stimulation influences sedation stability, reduces anesthetic consumption, and improves recovery time during pediatric MRI.

Eligibility Criteria

Inclusion Criteria: * Age between 6 months and 12 years. * Scheduled to undergo MRI requiring sedation. * American Society of Anesthesiologists (ASA) Physical Status I-III. * Able to use MRI-compatible headphones. * Parent or legal guardian able to provide written informed consent. Exclusion Criteria: * Age under 6 months or over 12 years. * Known allergy, intolerance, or contraindication to sedative medications used in institutional protocols. * History of airway anomalies, difficult airway, or conditions increasing anesthesia risk. * Hearing impairment or auditory limitations preventing perception of sound stimuli. * Contraindications to MRI (e.g., metallic implants, pacemaker, severe claustrophobia). * Inability to obtain informed consent from parent or legal guardian. * Sedation failure or unsuccessful MRI procedure. * Use of medications or medical conditions that may interfere with sedation assessment or auditory perception. * Acute respiratory infection or active upper airway dis

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