Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-08

Study Completion Date

2026-02-16

Brief Summary

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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.

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Detailed Description

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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

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Pediatric Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three-arm, parallel-group, randomized controlled design evaluating the effects of lullaby music, white noise, and silent headphone use on sedation depth, anesthetic requirements, and recovery outcomes during pediatric MRI

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants, care providers, investigators, and outcome assessors are blinded to group allocation. Only the radiology technician operating the MRI scanner and initiating the auditory condition (lullaby, white noise, or silent headphones) is aware of the assignment; the technician is not involved in sedation management or outcome assessment."

Study Groups

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Silent Headphone Group

Participants wear MRI-compatible headphones without any auditory input. No music or noise is delivered throughout the MRI procedure. Standard sedoanalgesia is administered according to institutional protocol.

Group Type OTHER

Silent Headphone

Intervention Type BEHAVIORAL

Use of MRI-compatible headphones without auditory input during the MRI procedure.

White Noise Group

Participants receive continuous white noise through MRI-compatible headphones starting immediately after sedoanalgesia and continuing throughout the MRI examination. All other clinical care follows standard pediatric sedation practice.

Group Type OTHER

White Noise

Intervention Type BEHAVIORAL

Continuous delivery of white noise through MRI-compatible headphones throughout the MRI procedure

Lullaby Music Group

Participants receive continuous lullaby music through MRI-compatible headphones beginning after sedoanalgesia and continuing for the duration of the MRI procedure. Sedation and monitoring follow standard institutional protocols.

Group Type OTHER

Lullaby Music

Intervention Type BEHAVIORAL

Continuous delivery of lullaby music through MRI-compatible headphones for the duration of the MRI examination

Interventions

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Silent Headphone

Use of MRI-compatible headphones without auditory input during the MRI procedure.

Intervention Type BEHAVIORAL

White Noise

Continuous delivery of white noise through MRI-compatible headphones throughout the MRI procedure

Intervention Type BEHAVIORAL

Lullaby Music

Continuous delivery of lullaby music through MRI-compatible headphones for the duration of the MRI examination

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No