Clinical trial NCT04236674: Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
Official title: Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Analgesia
Anxiety
Keywords: Distraction
Thermomechanical analgesia
Music
Anxiety
Pain
Analgesia
Buzzy
Interventional radiology
IR
Picc
Paracentesis
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 18-90 years of age

Exclusion Criteria:

* prisoners, elderly, minors, pregnant women

Primary outcomes:
measure: Pain visual analog scale - pre-procedure
timeFrame: Baseline (Prior to the procedure)
measure: Anxiety visual analog scale - pre-procedure
timeFrame: Baseline (Prior to the procedure)
measure: Pain visual analog scale - post-procedure
timeFrame: Immediately after the procedure
measure: Anxiety visual analog scale - post-procedure
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Satisfaction survey
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Ryan Michael Cobb
state: Pennsylvania
Study officials:
affiliation: Temple University Hospital
name: Ryan M Cobb, MD
role: STUDY_DIRECTOR
References: