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Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

NCT07325331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Pediatric Sedation

Interventions

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

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    lead OTHER

Principal Investigators

  • Fatma Acil, M.D. · Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2026-04-02
Completion
2026-04-03

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07325331 on ClinicalTrials.gov