Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital112 enrolled

Overview

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.

This prospective randomized study is designed to investigate the effects of three auditory conditions-lullaby music, white noise, and silent headphone use-on sedation depth, anesthetic drug requirements, motion-related sequence repetition, and recovery outcomes during pediatric magnetic resonance imaging (MRI). Children aged 6 months to 12 years who require MRI under sedation will be enrolled. Participants will be randomly assigned to one of three groups: (1) silent headphone control, (2) white noise, or (3) lullaby music. Auditory stimulation in the white noise and lullaby groups will begin immediately after sedoanalgesia and will continue uninterrupted throughout the MRI examination. The control group will wear headphones without any auditory input. Standard sedoanalgesia will be administered according to institutional pediatric anesthesia practice. During the MRI procedure, heart rate, oxygen saturation, and respiratory rate will be monitored continuously, with values recorded at 5-minute intervals. Any movement that compromises image quality will be documented, including the need for additional anesthetic dosing and repetition of imaging sequences. Procedure-related complications will also be recorded. Following completion of the MRI, all participants will be transferred to the recovery area, where sedation and recovery assessments will be performed using the Ramsey Sedation Scale and the Modified Aldrete Score until discharge criteria are met. Demographic variables, diagnosis, MRI region, contrast use, total sedation time, MRI duration, auditory stimulation duration, anesthetic doses administered before and during MRI, and total time to discharge will be recorded for outcome comparison. The study aims to determine whether specific auditory stimuli can enhance sedation stability, minimize anesthetic drug requirements, reduce movement-related interruptions, and shorten recovery time in pediatric patients undergoing MRI. The findings may help identify non-pharmacologic strategies to optimize pediatric sedation, improve imaging quality, and enhance patient safety in clinical practice.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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 disease that increases sedation risk

Outcomes

Primary Outcomes

Total Anesthetic Drug Consumption

Total amount of sedative/anesthetic medication administered during the MRI procedure, recorded in milligrams. Includes initial and additional doses required due to movement or inadequate sedation.

Time frame: Periprocedural (during MRI examination)

Secondary Outcomes

Sedation Depth

Depth of sedation will be assessed using the Ramsey Sedation Scale immediately following completion of the MRI examination. Higher scores indicate deeper sedation.

Time frame: Immediately at the end of the MRI procedure

Motion Requiring Sequence Repetition

Number of MRI sequences repeated due to patient movement that compromises image quality. The total count of repeated sequences will be compared among the three auditory intervention groups.

Time frame: Periprocedural (during MRI examination)

Recovery Time

Time interval from the end of the MRI examination until the patient reaches a Modified Aldrete Score ≥ 9 in the recovery area. This measure reflects post-sedation recovery efficiency

Time frame: assessed up to 120 minutes post-procedure

Heart Rate During MRI

Heart rate will be continuously monitored and recorded at 5-minute intervals throughout the MRI procedure. Heart rate values will be analyzed to assess sedation stability and compared among the three auditory conditions.

Time frame: Periprocedural (during MRI scan)

Postoperative Nausea

Presence or absence of postoperative nausea assessed during the first 24 hours after surgery. The occurrence will be recorded as a binary outcome (yes/no).