Effect of Intra-procedure Music on Anxiety

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of intra-procedure music intervention on procedural anxiety, physiological stress and sedation requirements in patients undergoing moderate sedation procedures. Study participants will be randomly assigned into two groups: 1. Control - standard care without music intervention. 2. Intervention - standard of care plus music intervention. The State-Trait Anxiety Inventory questionnaire will be provided pre, intra and post procedure to all subjects in addition to an exit survey.

Official Title
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Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures

Conditions
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Anxiety

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (>18 years old) patients Scheduled for moderate sedation procedures in the Interventional Radiology department at Tisch Hospital, NYU Langone Health in New York, New York Able to read and write in English at a sixth grade level (STAI is written at sixth grade comprehension level) Exclusion Criteria: Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients in this arm will receive patient-selected music through headphones throughout their procedure. | Other: Music<br>* Intra-procedure music through headphones<br>|
| No Intervention: Control<br>Patients will be wearing headphones during their procedure (for the purpose of blinding the care team), but will not receive any music, sounds or sound-cancelling effects through the headphones. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) score | To examine the effects of intra-procedure music on subjects' anxiety surrounding (pre, during, post) procedures in interventional radiology. Anxiety will be measured by a validated questionnaire called the State-Trait Anxiety Inventory (STAI) | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | To examine the effects of intra-procedure music on subjects' heart rate in interventional radiology procedures | Up to 12 months | 
| Respiration rate | To examine the effects of intra-procedure music on subjects' respiration rate in interventional radiology procedures | Up to 12 months | 
| Blood pressure | To examine the effects of intra-procedure music on subjects' blood pressure in interventional radiology procedures | Up to 12 months | 
| Amount of sedation required | To examine the effects of intra-procedure music on the amount of sedation required for subjects in interventional radiology procedures | Up to 12 months | 
| Pain score | To examine the effects of intra-procedure music on the subjects' pain scores during interventional radiology procedures | Up to 12 months | 
| RASS score | To examine the effects of intra-proceudre music on the subjects' RASS scores during interventional radiology procedures | Up to 12 months |