Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 16, 2020
First Posted Date  ICMJE January 22, 2020
Last Update Posted Date January 27, 2020
Estimated Study Start Date  ICMJE January 27, 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
Satisfaction survey [ Time Frame: Immediately after the procedure ]
Patient reported satisfaction survey post-procedure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
Official Title  ICMJE Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Analgesia
  • Anxiety
Intervention  ICMJE
  • Device: Buzzy thermomechanical device
    Buzzy thermomechanical device placed near intervention site.
  • Behavioral: Music Selection
    Patient specified procedural music
Study Arms  ICMJE
  • No Intervention: No intervention
  • Experimental: Buzzy
    Thermomechanical device for periprocedural analgesia
    Intervention: Device: Buzzy thermomechanical device
  • Experimental: Music Selection
    Patient specified music selection for procedural room
    Intervention: Behavioral: Music Selection
  • Experimental: Buzzy and Music Selection
    A combination of use of the Buzzy device and patient specified music selection
    Interventions:
    • Device: Buzzy thermomechanical device
    • Behavioral: Music Selection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2020)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-90 years of age

Exclusion Criteria:

  • prisoners, elderly, minors, pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ryan M Cobb, MD 215.707.0082 ryan.cobb@tuhs.temple.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04236674
Other Study ID Numbers  ICMJE TempleU25969
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ryan M Cobb, MD Temple University Hospital
PRS Account Temple University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP