Pediatric SedationCALMMRINCT07325331
Lullaby vs White Noise vs Silence in Pediatric MRI Sedation
A study testing Silent Headphone, White Noise and Lullaby Music in people with Pediatric Sedation, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Pediatric Sedation
- What is being tested?
- Silent Headphone, White Noise and Lullaby Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2026to 3 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey, 21070
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Sedation
- Being tested
- Silent Headphone, White Noise, Lullaby Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silent HeadphoneBehavioural
Use of MRI-compatible headphones without auditory input during the MRI procedure.
White NoiseBehavioural
Continuous delivery of white noise through MRI-compatible headphones throughout the MRI procedure
Lullaby MusicBehavioural
Continuous delivery of lullaby music through MRI-compatible headphones for the duration of the MRI examination
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Lullaby Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural (during MRI examination)
Secondary outcomes (10)
Sedation Depth
Depth of sedation will be assessed using the Ramsey Sedation Scale immediately following completion of the MRI examination. Higher scores indicate deeper sedation.
Measured: Immediately at the end of the MRI procedure
Motion Requiring Sequence Repetition
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.
Measured: Periprocedural (during MRI examination)
Recovery Time
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
Measured: assessed up to 120 minutes post-procedure
Heart Rate During MRI
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.
Measured: Periprocedural (during MRI scan)
Postoperative Nausea
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).
Measured: Assessed Periprocedural and up to 120 minutes post-procedure
Postoperative Vomiting
Occurrence of postoperative vomiting during the first 24 hours after surgery. The occurrence will be recorded as a binary outcome (yes/no).
Measured: Assessed Periprocedural and up to 120 minutes post-procedure
Incidence of Oxygen Desaturation
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.
Measured: Assessed Periprocedural and up to 120 minutes post-procedure
Incidence of Airway Obstruction
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.
Measured: Assessed Periprocedural and up to 120 minutes post-procedure
Incidence of Unexpected Agitation
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.
Measured: Assessed Periprocedural and up to 120 minutes post-procedure
Oxygen Saturation During MRI
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.
Measured: Periprocedural (during MRI scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start8 Jan 2026
- Primary completion2 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, M.D., Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325331
- Sponsor's protocol ID
- 12.2.2025-
- Acronym
- CALMMRI
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36628804