Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.
NCT ID: NCT04944875
Last Updated: 2021-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2019-05-01
2021-05-01
Brief Summary
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Detailed Description
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Patients were categorized into 3 groups: music, maternal voice and isolation. During the procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music.
All patients were sedated by midazolam and propofol. During the procedure, an additional propofol was administered as required
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Group I; group headphone
In the first group of the patients in the isolation group wear the headphones but do not listen to music during the procedure. Then patients were sedated by midazolam and propofol.
Group headphone
The patients in the first group wore the headphones but did not listen the music or maternal voice. The standard sedation method was applied to all patients.
Group II; group music
In the second group of the patients wear the headphones and listen to Vivaldi's The Four Seasons violin concertos by sound isolating headphones during the procedure.
Then patients were sedated by midazolam and propofol.
Group music
The patients in the second group listened to classical music (Vivaldi's The Four Seasons violin concertos) by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
Group III; group maternal voice
In the third group of the patients wear the headphones and listen the maternal voice during the procedure.Then patients were sedated by midazolam and propofol.
Group maternal voice
The patients in the third group listened to maternal voice by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
Interventions
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Group headphone
The patients in the first group wore the headphones but did not listen the music or maternal voice. The standard sedation method was applied to all patients.
Group music
The patients in the second group listened to classical music (Vivaldi's The Four Seasons violin concertos) by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
Group maternal voice
The patients in the third group listened to maternal voice by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
12 Years
ALL
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Özlem ÖZ GERGİN
Principal Investigator
Principal Investigators
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Ozlem Oz Gergin
Role: PRINCIPAL_INVESTIGATOR
TC Erciyes University
Locations
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Özlem Öz Gergin
Kayseri, , Turkey (Türkiye)
Countries
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References
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Starkey E, Sammons HM. Sedation for radiological imaging. Arch Dis Child Educ Pract Ed. 2011 Jun;96(3):101-6. doi: 10.1136/adc.2008.153072. Epub 2010 Jul 30. No abstract available.
Ahmad R, Hu HH, Krishnamurthy R, Krishnamurthy R. Reducing sedation for pediatric body MRI using accelerated and abbreviated imaging protocols. Pediatr Radiol. 2018 Jan;48(1):37-49. doi: 10.1007/s00247-017-3987-6. Epub 2018 Jan 1.
Other Identifiers
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2019/266
Identifier Type: -
Identifier Source: org_study_id