Music in Interventional Radiology Procedures

• Sponsor: Western University, Canada (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05728398
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Other: Music; Other: No Music	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Music in Interventional Radiology Procedures: Effect on Patient and Staff Experience
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Procedural Sedation required [Intra-procedure]

   Dosage of Fentanyl and Midazolam required during interventional radiology procedure

Secondary Outcome Measures

1. Participant intra-procedural anxiety [Intra-procedure]

   Assess peri-procedural anxiety using State-Trait Anxiety Inventory scale

2. Participant procedural pain [Immediately post-procedure]

   Participant qualitative assessment of procedural pain using Visual Analog Scale (VAS)

3. Participant Procedural Experience [Immediately post-procedure]

   Participant Experience qualitative assessment using Likert scale

4. Interventional radiology procedure length [Intra-procedure]

   Measure the total time required to perform the IR procedure

5. Healthcare team experience [Immediately post-procedure]

   Assess procedural healthcare team's (physician, IR nurse, & IR technologist) perceived impact of music on the procedure experience (Likert scale)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Western University, Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Western University, Canada
• ClinicalTrials.gov Identifier: NCT05728398
• Other Study ID Numbers: WESTERNU_IR 001
• First Posted: Feb 15, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Western University, Canada: Interventional radiology; Music; procedure sedation; patient experience

Study Results

No Results Posted as of Feb 15, 2023