RecruitingNot ApplicableNCT07325331

Lullaby vs White Noise vs Silence in Pediatric MRI Sedation

Effects of Lullaby, White Noise, and Silent Headphone Use on Sedation Depth, Anesthetic Requirements, and Recovery Time in Children Undergoing MRI: A Prospective Randomized Controlled Trial


Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Enrollment

120 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 12 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

BEHAVIORALSilent Headphone

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

BEHAVIORALWhite Noise

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

BEHAVIORALLullaby Music

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


Locations(1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)

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NCT07325331


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