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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04236674
Enrollment
450
Registered
2020-01-22
Start date
2020-01-27
Completion date
2021-03-31
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Anxiety, Pain

Keywords

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

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.

Interventions

DEVICEBuzzy thermomechanical device

Buzzy thermomechanical device placed near intervention site.

BEHAVIORALMusic Selection

Patient specified procedural music

Sponsors

Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-90 years of age

Exclusion criteria

* prisoners, elderly, minors, pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Pain visual analog scale - pre-procedureBaseline (Prior to the procedure)VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
Anxiety visual analog scale - pre-procedureBaseline (Prior to the procedure)VAS pre-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
Pain visual analog scale - post-procedureImmediately after the procedureVAS post-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
Anxiety visual analog scale - post-procedureImmediately after the procedureVAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety

Secondary

MeasureTime frameDescription
Satisfaction surveyImmediately after the procedurePatient reported satisfaction survey post-procedure

Countries

United States

Contacts

Primary ContactRyan M Cobb, MD
ryan.cobb@tuhs.temple.edu215.707.0082

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026