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

April 3, 2026 updated by: Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Diyarbakır, Turkey, Turkey (Türkiye), 21070
        • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Behavioral: Silent Headphone
Use of MRI-compatible headphones without auditory input during the MRI procedure.
Other: 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.
Behavioral: White Noise
Continuous delivery of white noise through MRI-compatible headphones throughout the MRI procedure
Other: 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.
Behavioral: Lullaby Music
Continuous delivery of lullaby music through MRI-compatible headphones for the duration of the MRI examination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Anesthetic Drug Consumption
Time Frame: Periprocedural (during MRI examination)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sedation Depth
Time Frame: Immediately at the end of the MRI procedure
Depth of sedation will be assessed using the Ramsey Sedation Scale immediately following completion of the MRI examination. Higher scores indicate deeper sedation.
Immediately at the end of the MRI procedure
Motion Requiring Sequence Repetition
Time Frame: Periprocedural (during MRI examination)
Number of MRI sequences repeated due to patient movement that compromises image quality. The total count of repeated sequences will be compared among the three auditory intervention groups.
Periprocedural (during MRI examination)
Recovery Time
Time Frame: assessed up to 120 minutes post-procedure
Time interval from the end of the MRI examination until the patient reaches a Modified Aldrete Score ≥ 9 in the recovery area. This measure reflects post-sedation recovery efficiency
assessed up to 120 minutes post-procedure
Heart Rate During MRI
Time Frame: Periprocedural (during MRI scan)
Heart rate will be continuously monitored and recorded at 5-minute intervals throughout the MRI procedure. Heart rate values will be analyzed to assess sedation stability and compared among the three auditory conditions.
Periprocedural (during MRI scan)
Postoperative Nausea
Time Frame: Assessed Periprocedural and up to 120 minutes post-procedure
Presence or absence of postoperative nausea assessed during the first 24 hours after surgery. The occurrence will be recorded as a binary outcome (yes/no).
Assessed Periprocedural and up to 120 minutes post-procedure
Postoperative Vomiting
Time Frame: Assessed Periprocedural and up to 120 minutes post-procedure
Occurrence of postoperative vomiting during the first 24 hours after surgery. The occurrence will be recorded as a binary outcome (yes/no).
Assessed Periprocedural and up to 120 minutes post-procedure
Incidence of Oxygen Desaturation
Time Frame: Assessed Periprocedural and up to 120 minutes post-procedure
Oxygen desaturation will be defined as a peripheral oxygen saturation (SpO₂) value below 90% lasting for at least 10 seconds during the procedure. The occurrence of oxygen desaturation will be recorded as a binary variable (yes/no) and compared among the three study groups.
Assessed Periprocedural and up to 120 minutes post-procedure
Incidence of Airway Obstruction
Time Frame: Assessed Periprocedural and up to 120 minutes post-procedure
Airway obstruction will be defined as the presence of clinical signs requiring airway intervention, including jaw thrust, chin lift, insertion of an airway adjunct, or bag-mask ventilation. Events will be recorded as present or absent and compared among the three study groups.
Assessed Periprocedural and up to 120 minutes post-procedure
Incidence of Unexpected Agitation
Time Frame: Assessed Periprocedural and up to 120 minutes post-procedure
Unexpected agitation will be defined as agitation requiring additional sedative or anesthetic intervention or interruption of the procedure, corresponding to a Richmond Agitation-Sedation Scale (RASS) score of +2 or higher. The occurrence will be recorded as a binary outcome (yes/no) and compared among the three study groups.
Assessed Periprocedural and up to 120 minutes post-procedure
Oxygen Saturation During MRI
Time Frame: Periprocedural (during MRI scan)
Peripheral oxygen saturation (SpO₂) will be continuously monitored and recorded at 5-minute intervals during the MRI procedure. SpO₂ values will be analyzed to evaluate sedation stability and compared among the three auditory conditions.
Periprocedural (during MRI scan)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12.2.2025-

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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