Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction

Conditions
-----------------
Pain, Analgesia, Anxiety

Intervention / Treatment
-----------------
* Device: Buzzy thermomechanical device
* Behavioral: Music Selection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-90 years of age Exclusion Criteria: prisoners, elderly, minors, pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br> | |
| Experimental: Buzzy<br>Thermomechanical device for periprocedural analgesia | Device: Buzzy thermomechanical device<br>* Buzzy thermomechanical device placed near intervention site.<br>|
| Experimental: Music Selection<br>Patient specified music selection for procedural room | Behavioral: Music Selection<br>* Patient specified procedural music<br>|
| Experimental: Buzzy and Music Selection<br>A combination of use of the Buzzy device and patient specified music selection | Device: Buzzy thermomechanical device<br>* Buzzy thermomechanical device placed near intervention site.<br>Behavioral: Music Selection<br>* Patient specified procedural music<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction survey | Patient reported satisfaction survey post-procedure | Immediately after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Distraction, Thermomechanical analgesia, Music, Anxiety, Pain, Analgesia, Buzzy, Interventional radiology, IR, Picc, Paracentesis