Music in Interventional Radiology Procedures

Patient Satisfaction Clinical Trial

Official title:

Music in Interventional Radiology Procedures: Effect on Patient and Staff Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05728398
• Other study ID #: WESTERNU_IR 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2023
• Source: Western University, Canada
• Contact: Derek W Cool, MD, PhD
• Phone: 5196858500
• Email: derek.cool[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of music as medical therapy for the treatment of mental health conditions like depression and anxiety is well established. Furthermore, music is sometimes played in operating rooms and several small single center studies done during cardiology and interventional radiology procedures have demonstrated that the use of music can decrease in the use of sedation medications, pain, and anxiety during the procedures. These past studies have only looked at the impact on the participants, as the music was delivered to the participants only through headphones. This means that the impact of music on the healthcare team was not studied. However, separate systematic literature reviews on the impact of playing music in operating rooms during surgical procedures have highlighted some positive effects music has on the surgeon and the surgical team. The purpose of this study is to evaluate the effects of playing music during interventional radiology procedures on the participants and the healthcare team. One way of studying this is to compare the responses and experience of participants and healthcare team that hear ambient music during the procedure with those who did not.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing an out-patient or non-emergent in-patient interventional radiology procedure

Exclusion Criteria:

• Participants unable to consent or complete survey information
• Participants receiving procedures under general anesthesia
• Participants unable to receive IV conscious sedation
• Emergent cases or those performed outside of routine hospital hours

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Other:
• Music
Music played within the fluoroscopy suite during an interventional radiology procedure.
• No Music
No music played within the fluoroscopy suite during an interventional radiology procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Sedation required	Dosage of Fentanyl and Midazolam required during interventional radiology procedure	Intra-procedure
Secondary	Participant intra-procedural anxiety	Assess peri-procedural anxiety using State-Trait Anxiety Inventory scale	Intra-procedure
Secondary	Participant procedural pain	Participant qualitative assessment of procedural pain using Visual Analog Scale (VAS)	Immediately post-procedure
Secondary	Participant Procedural Experience	Participant Experience qualitative assessment using Likert scale	Immediately post-procedure
Secondary	Interventional radiology procedure length	Measure the total time required to perform the IR procedure	Intra-procedure
Secondary	Healthcare team experience	Assess procedural healthcare team's (physician, IR nurse, & IR technologist) perceived impact of music on the procedure experience (Likert scale)	Immediately post-procedure