Music in Interventional Radiology Procedures

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Music; Other: No Music

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Music Intervention Group; Participants randomized to receive music intervention during interventional radiology procedure.	Other: Music; Music played within the fluoroscopy suite during an interventional radiology procedure.
Sham Comparator: No Music Comparator Group; Participants randomized to have no music played during interventional radiology procedure.	Other: No Music; No music played within the fluoroscopy suite during an interventional radiology procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Sedation required	Dosage of Fentanyl and Midazolam required during interventional radiology procedure	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant intra-procedural anxiety	Assess peri-procedural anxiety using State-Trait Anxiety Inventory scale	Intra-procedure
Participant procedural pain	Participant qualitative assessment of procedural pain using Visual Analog Scale (VAS)	Immediately post-procedure
Participant Procedural Experience	Participant Experience qualitative assessment using Likert scale	Immediately post-procedure
Interventional radiology procedure length	Measure the total time required to perform the IR procedure	Intra-procedure
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

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Music; patient experience; procedure sedation; Interventional radiology
• Other Study ID Numbers: WESTERNU_IR 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No