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

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 Overview

• Status: Unknown
• Conditions: Pain; Analgesia; Anxiety
• Intervention / Treatment: Device: Buzzy thermomechanical device; Behavioral: Music Selection

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 Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19130
      • Recruiting
      • Ryan Michael Cobb
      • Contact: Ryan M Cobb, MD; Phone Number: 215-707-0082; Email: ryan.cobb@tuhs.temple.edu
      • Contact: Pratik Patel, DO; Phone Number: 215.707.0082; Email: Pratik.patel@tuhs.temple.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-90 years of age

Exclusion Criteria:

• prisoners, elderly, minors, pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: No intervention
EXPERIMENTAL: Buzzy; Thermomechanical device for periprocedural analgesia	Device: Buzzy thermomechanical device; Buzzy thermomechanical device placed near intervention site.
EXPERIMENTAL: Music Selection; Patient specified music selection for procedural room	Behavioral: Music Selection; Patient specified procedural music
EXPERIMENTAL: Buzzy and Music Selection; A combination of use of the Buzzy device and patient specified music selection	Device: Buzzy thermomechanical device; Buzzy thermomechanical device placed near intervention site.; Behavioral: Music Selection; Patient specified procedural music

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

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Study Director: Ryan M Cobb, MD, Temple University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (ACTUAL): January 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Analgesia; Music; Paracentesis; Distraction; Interventional radiology; Buzzy; IR; Thermomechanical analgesia; Picc
• Other Study ID Numbers: TempleU25969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No