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

Not Applicable

• Conditions: Anxiety; Analgesia; Pain
• Interventions: Device: Buzzy thermomechanical device; Behavioral: Music Selection

• Registration Number: NCT04236674
• Lead Sponsor: Temple University

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.

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-22
• Study Start: 2020-01-27
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• 18-90 years of age

Exclusion Criteria

• prisoners, elderly, minors, pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buzzy and Music Selection	Buzzy thermomechanical device	A combination of use of the Buzzy device and patient specified music selection
Buzzy	Buzzy thermomechanical device	Thermomechanical device for periprocedural analgesia
Buzzy and Music Selection	Music Selection	A combination of use of the Buzzy device and patient specified music selection
Music Selection	Music Selection	Patient specified music selection for procedural room

Primary Outcome Measures

Name	Time	Method
Anxiety visual analog scale - pre-procedure	Baseline (Prior to the procedure)	VAS pre-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
Pain visual analog scale - post-procedure	Immediately after the procedure	VAS post-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
Anxiety visual analog scale - post-procedure	Immediately after the procedure	VAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
Pain visual analog scale - pre-procedure	Baseline (Prior to the procedure)	VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable

Secondary Outcome Measures

Name	Time	Method
Satisfaction survey	Immediately after the procedure	Patient reported satisfaction survey post-procedure

Trial Locations

Locations (1)

Ryan Michael Cobb; 🇺🇸 Philadelphia, Pennsylvania, United States