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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04236674
• Other study ID #: TempleU25969
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: March 2021

Study information

• Verified date: October 2020
• Source: Temple University
• Contact: Ryan M Cobb, MD
• Phone: 215.707.0082
• Email: ryan.cobb[@]tuhs.temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18-90 years of age

Exclusion Criteria:

• prisoners, elderly, minors, pregnant women

Related Conditions & MeSH terms

• Analgesia
• Anxiety
• Pain

Intervention

Device:
• Buzzy thermomechanical device
Buzzy thermomechanical device placed near intervention site.

Behavioral:
• Music Selection
Patient specified procedural music

Locations

Country	Name	City	State
United States	Ryan Michael Cobb	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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	Satisfaction survey	Patient reported satisfaction survey post-procedure	Immediately after the procedure