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

NCT ID: NCT04236674

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2021-03-31

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.

Conditions

Pain; Analgesia; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Buzzy

Thermomechanical device for periprocedural analgesia

Group Type: EXPERIMENTAL

Buzzy thermomechanical device

Intervention Type: DEVICE

Buzzy thermomechanical device placed near intervention site.

Music Selection

Patient specified music selection for procedural room

Group Type: EXPERIMENTAL

Music Selection

Intervention Type: BEHAVIORAL

Patient specified procedural music

Buzzy and Music Selection

A combination of use of the Buzzy device and patient specified music selection

Group Type: EXPERIMENTAL

Buzzy thermomechanical device

Intervention Type: DEVICE

Buzzy thermomechanical device placed near intervention site.

Music Selection

Intervention Type: BEHAVIORAL

Patient specified procedural music

Interventions

Buzzy thermomechanical device

Buzzy thermomechanical device placed near intervention site.

Intervention Type: DEVICE

Music Selection

Patient specified procedural music

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-90 years of age

Exclusion Criteria

• prisoners, elderly, minors, pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan M Cobb, MD

Role: STUDY_DIRECTOR

Temple University Hospital

Locations

Ryan Michael Cobb

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan M Cobb, MD

Role: CONTACT

ryan.cobb@tuhs.temple.edu

215.707.0082

Facility Contacts

Ryan M Cobb, MD

Role: primary

ryan.cobb@tuhs.temple.edu

215-707-0082

Pratik Patel, DO

Role: backup

Pratik.patel@tuhs.temple.edu

215.707.0082

Other Identifiers

TempleU25969

Identifier Type: -

Identifier Source: org_study_id