Lullaby vs White Noise vs Silence in Pediatric MRI Sedation (CALMMRI)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status: Enrolling

Conditions: Pediatric Sedation

Treatments: Behavioral: White Noise; Behavioral: Lullaby Music; Behavioral: Silent Headphone

Study type: Interventional

Funder types: Other

Identifiers

NCT07325331

12.2.2025-

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

Silent Headphone Group

Other group

Description:

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.

Treatment:

Behavioral: Silent Headphone

White Noise Group

Other group

Description:

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.

Treatment:

Behavioral: White Noise

Lullaby Music Group

Other group

Description:

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.

Treatment:

Behavioral: Lullaby Music