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The study will prospectively analyze the analgesic and anxiolytic effects of thermomechanical stimulation (cold and vibration effects) with or without patient selected music preference during non-sedating interventional radiology procedures.
There are wide ranging influences on the perception of human pain. The perception of pain is shaped by physiology, genetic factors, prior experiences, and external ameliorating factors. Extensive research has been performed in the pediatric population utilizing distraction as a means of reducing pain, particularly during venipuncture. These methods include medications (i.e. creams, anxiolytics), behavioral distraction (i.e. music, games), cold anesthesia, and thermomechanical stimulation via a cooling/vibrating device; however, fear and anxiety associated with needle procedures does not always resolve with time or age and can result in avoidance of treatment and delays in care. Few studies have focused on the impact of non-pharmacologic anxiolytics using thermomechanical stimulation and social anesthesia (i.e. music as a form of distraction) in the adult population. Utilizing non-pharmacologic measures is one of the first steps in procedural pain management. A thermomechanical device used in the pediatric population called Buzzy (MMJ Labs, Atlanta GA) employs a battery operated, handheld plastic device with a vibrating motor and a mechanism to attach an ice pack. This is used either independently or in combination. Most reports of the device demonstrate significant pain relief, but the majority of these completed studies focused on children undergoing venous cannulation. There have been a few cited uses in adult podiatry, dermatology, and pain management. In addition, passive music based intervention have been used in cancer patients undergoing biopsy and surgery, revealing a significant pain reduction effect. The study will prospectively analyze the analgesic and anxiolytic effects of thermomechanical stimulation (cold and vibration effects) with or without patient selected music preference during non-sedating interventional radiology procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No Intervention | ||
| Buzzy | Experimental | Thermomechanical device for periprocedural analgesia |
|
| Music Selection | Experimental | Patient specified music selection for procedural room |
|
| Buzzy and Music Selection | Experimental | A combination of use of the Buzzy device and patient specified music selection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy thermomechanical device | Device | Buzzy thermomechanical device placed near intervention site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain visual analog scale - pre-procedure | VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable | Baseline (Prior to the procedure) |
| Anxiety visual analog scale - pre-procedure | VAS pre-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety | Baseline (Prior to the procedure) |
| Pain visual analog scale - post-procedure | VAS post-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable | Immediately after the procedure |
| Anxiety visual analog scale - post-procedure | VAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction survey | Patient reported satisfaction survey post-procedure | Immediately after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan M Cobb, MD | Contact | 215.707.0082 | ryan.cobb@tuhs.temple.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan M Cobb, MD | Temple University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryan Michael Cobb | Recruiting | Philadelphia | Pennsylvania | 19130 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| Music Selection | Behavioral | Patient specified procedural music |
|
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |