Music in Interventional Radiology Procedures

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Patient Satisfaction

Intervention / Treatment
-----------------
* Other: Music
* Other: No Music


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interventional radiology, Music, procedure sedation, patient experience