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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236674
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Analgesia Anxiety Device: Buzzy thermomechanical device Behavioral: Music Selection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
Estimated Study Start Date : January 27, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety X-Rays

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




Primary Outcome Measures :
  1. Pain visual analog scale - pre-procedure [ Time Frame: Baseline (Prior to the procedure) ]
    VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable

  2. Anxiety visual analog scale - pre-procedure [ Time Frame: Baseline (Prior to the procedure) ]
    VAS pre-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety

  3. Pain visual analog scale - post-procedure [ Time Frame: Immediately after the procedure ]
    VAS post-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable

  4. Anxiety visual analog scale - post-procedure [ Time Frame: Immediately after the procedure ]
    VAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety


Secondary Outcome Measures :
  1. Satisfaction survey [ Time Frame: Immediately after the procedure ]
    Patient reported satisfaction survey post-procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-90 years of age

Exclusion Criteria:

  • prisoners, elderly, minors, pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236674


Contacts
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Contact: Ryan M Cobb, MD 215.707.0082 ryan.cobb@tuhs.temple.edu

Locations
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United States, Pennsylvania
Ryan Michael Cobb Recruiting
Philadelphia, Pennsylvania, United States, 19130
Contact: Ryan M Cobb, MD    215-707-0082    ryan.cobb@tuhs.temple.edu   
Contact: Pratik Patel, DO    215.707.0082    Pratik.patel@tuhs.temple.edu   
Sponsors and Collaborators
Temple University
Investigators
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Study Director: Ryan M Cobb, MD Temple University Hospital

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04236674    
Other Study ID Numbers: TempleU25969
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Temple University:
Distraction
Thermomechanical analgesia
Music
Anxiety
Pain
Analgesia
Buzzy
Interventional radiology
IR
Picc
Paracentesis
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs