Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate, subjectively and objectively, whether playing music during procedures for treatment of chronic lower back pain has an effect on patients' anxiety and pain. The investigators hypothesize that playing music will result in reduced patient reported anxiety and pain scores and less variation from baseline of vital signs versus patients in the control group without music therapy. This is a pilot study.

Official Title
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Effect of Music on Pain and Anxiety in Chronic Pain Patients Undergoing Lumbar Interventional Procedures

Conditions
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Anxiety, Chronic Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 Female or male Patients undergoing standard of care lumbar spinal interventional procedures including: epidural steroid injections, facet injections, medial branch blocks Exclusion Criteria: Patients who cannot consent for themselves, including cognitively impaired patients. Non-English speaking patients Patients taking beta blocker medication Patients that have a pacer and have a set rate Patients with self-reported hearing problems or with hearing aids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Music<br>No music will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks). | Other: No Music<br>* No music will be played during the subject's interventional procedure<br>|
| Experimental: Music Therapy<br>Music of the subject's preferred genre will be played during the subject's standard of care lumbar spinal interventional procedure (including: epidural steroid injections, facet injections, medial branch blocks). | Other: Music Therapy<br>* We will play music of the subject's choice of genre during the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-procedure State-Trait Anxiety Inventory (STAI) Score | A measure of anxiety in a person. Higher score correlates increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160. | Within 30 minutes prior to the subject's interventional procedure | 
| Post-procedure State-Trait Anxiety Inventory (STAI) Score | A measure of anxiety in a person. Higher score correlates with increased anxiety and worsened outcome. The minimum score is 40 and the maximum score is 160. | Within 30 minutes following to the subject's interventional procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-procedural Visual Analog Score (VAS) for pain | Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10. | Within 30 minutes prior to the subject's interventional procedure | 
| Post procedural Visual Analog Score (VAS) | Visual Analog Score for pain. Higher score correlates with increased pain and worsened outcome. The minimum score is 0 and the maximum score is 10. | Within 30 minutes following the subject's interventional procedure |