Clinical Trial

Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

Study acronym: CALMMRI
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-04-07
notable Primary completion pushed: 2026-02-15 -> 2026-04-02 2026-04-07
minor Completion pushed: 2026-02-16 -> 2026-04-03 2026-04-07
Trial Details
NCT Number NCT07325331
Lead Sponsor Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Conditions Pediatric Sedation
Enrollment 112 participants
Start Date 2026-01-08
Primary Completion 2026-04-02 (estimated)
Study Completion 2026-04-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-06