NCT07325331

Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

Effects of Lullaby, White Noise, and Silent Headphone Use on Sedation Depth, Anesthetic Requirements, and Recovery Time in Children Undergoing MRI: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pediatric Sedation

Interventions

Type	Name	Description
BEHAVIORAL	Silent Headphone	Use of MRI-compatible headphones without auditory input during the MRI procedure.
BEHAVIORAL	White Noise	Continuous delivery of white noise through MRI-compatible headphones throughout the MRI procedure
BEHAVIORAL	Lullaby Music	Continuous delivery of lullaby music through MRI-compatible headphones for the duration of the MRI examination

Timeline

• Start date: 2026-01-08
• Primary completion: 2026-04-02
• Completion: 2026-04-03
• First posted: 2026-01-08
• Last updated: 2026-04-06

Locations

1 site across 1 country: Turkey (Türkiye)