Recruiting

Thermomechanical Distraction

Sponsor:

Temple University

Code:

NCT04236674

Conditions

Pain

Analgesia

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Buzzy thermomechanical device

Music Selection

Study Details

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.

Conditions

Pain

Analgesia

Anxiety

Study ID

NCT04236674

Start date

Jan 27, 2020

Status verified date

Oct, 2020

Completion date

Mar, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-90 years of age

Exclusion Criteria:

  • prisoners, elderly, minors, pregnant women

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No intervention

experimental: Buzzy

Thermomechanical device for periprocedural analgesia

experimental: Music Selection

Patient specified music selection for procedural room

experimental: Buzzy and Music Selection

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

Interventions

Buzzy thermomechanical device

Buzzy thermomechanical device placed near intervention site.

Music Selection

Patient specified procedural music

Primary outcome measure

  • Pain visual analog scale - pre-procedure [ Time Frame: Baseline (Prior to the procedure) ]
  • Anxiety visual analog scale - pre-procedure [ Time Frame: Baseline (Prior to the procedure) ]
  • Pain visual analog scale - post-procedure [ Time Frame: Immediately after the procedure ]
  • Anxiety visual analog scale - post-procedure [ Time Frame: Immediately after the procedure ]

Central Contacts and Locations

Central contacts

Ryan M Cobb, MD

215.707.0082ryan.cobb@tuhs.temple.edu

Locations

Ryan Michael Cobb

Recruiting

Philadelphia, Pennsylvania, United States, 19130

Contacts

Ryan M Cobb, MD

215-707-0082ryan.cobb@tuhs.temple.edu

Pratik Patel, DO

215.707.0082Pratik.patel@tuhs.temple.edu

More Information

Sponsor

Temple University

Last update posted

Oct 8, 2020

Last verified

Oct, 2020

Keywords

  • Distraction
  • Thermomechanical analgesia
  • Music
  • Anxiety
  • Pain
  • Analgesia
  • Buzzy
  • Interventional radiology
  • IR
  • Picc
  • Paracentesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2020-10-08.