Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.

Pediatric Cancer Clinical Trial

Official title:

Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944875
• Other study ID #: 2019/266
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Pediatric Brain Tumor
• Pediatric Cancer
• Pediatric Solid Tumor

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