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

Temple University

Status: Unknown

Conditions: Analgesia; Anxiety; Pain

Treatments: Device: Buzzy thermomechanical device; Behavioral: Music Selection

Study type: Interventional

Funder types: Other

Identifiers

NCT04236674

TempleU25969

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-90 years of age

Exclusion criteria

• prisoners, elderly, minors, pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 4 patient groups

No intervention

No Intervention group

Buzzy

Experimental group

Description:

Thermomechanical device for periprocedural analgesia

Treatment:

Device: Buzzy thermomechanical device

Music Selection

Experimental group

Description:

Patient specified music selection for procedural room

Treatment:

Behavioral: Music Selection

Buzzy and Music Selection

Experimental group

Description:

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

Treatment:

Behavioral: Music Selection

Device: Buzzy thermomechanical device