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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04944875
Other study ID # 2019/266
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date May 1, 2021

Study information

Verified date June 2021
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.


Description:

When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. 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


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria: - ASA (American Society of Anesthesiologists) I-II Exclusion Criteria: - Patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.

Study Design


Intervention

Procedure:
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.

Locations

Country Name City State
Turkey Özlem Öz Gergin Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary amount of propofol dose used in sedation The total propofol dosage were recorded in during procedure. during the MRI procedure
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