Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

NCT07325331 | Recruiting

• 1 other identifier: 12.2.2025-
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total Anesthetic Drug Consumption

  Total amount of sedative/anesthetic medication administered during the MRI procedure, recorded in milligrams. Includes initial and additional doses required due to movement or inadequate sedation.

  Periprocedural (during MRI examination)

Secondary Outcomes (10)

• Sedation Depth

  Immediately at the end of the MRI procedure

• Motion Requiring Sequence Repetition

  Periprocedural (during MRI examination)

• Recovery Time

  assessed up to 120 minutes post-procedure

• Heart Rate During MRI

  Periprocedural (during MRI scan)

• Postoperative Nausea

  Assessed Periprocedural and up to 120 minutes post-procedure

Study Arms (3)

Silent Headphone Group

OTHER

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.

Behavioral: Silent Headphone

White Noise Group

OTHER

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.

Behavioral: White Noise

Lullaby Music Group

OTHER

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.

Behavioral: Lullaby Music

Interventions

Silent Headphone BEHAVIORAL

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

Silent Headphone Group

White Noise BEHAVIORAL

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

White Noise Group

Lullaby Music BEHAVIORAL

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

Lullaby Music Group

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Gergin OO, Pehlivan SS, Erkan I, Bayram A, Aksu R, Gorkem SB, Bicer C, Yildiz K. The effect of playing music and mother's voice to children on sedation level and requirement during pediatric magnetic resonance imaging. Explore (NY). 2023 Jul-Aug;19(4):600-606. doi: 10.1016/j.explore.2023.01.001. Epub 2023 Jan 7.

  PMID: 36628804 BACKGROUND

Study Officials

• Fatma Acil, M.D.

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Acil, M.D.

CONTACT

+905337225225; acilfatma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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."
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 8, 2026
• Study Start: January 8, 2026
• Primary Completion: February 15, 2026
• Study Completion: February 16, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

TU (1)