NCT04236674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

January 16, 2020

Last Update Submit

October 5, 2020

Conditions

PainAnalgesiaAnxiety

Keywords

DistractionThermomechanical analgesiaMusicAnxietyPainAnalgesiaBuzzyInterventional radiologyIRPiccParacentesis

Outcome Measures

Primary Outcomes (4)

  • Pain visual analog scale - pre-procedure

    VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable

    Baseline (Prior to the procedure)

  • Anxiety visual analog scale - pre-procedure

    VAS pre-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety

    Baseline (Prior to the procedure)

  • Pain visual analog scale - post-procedure

    VAS post-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable

    Immediately after the procedure

  • Anxiety visual analog scale - post-procedure

    VAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety

    Immediately after the procedure

Secondary Outcomes (1)

  • Satisfaction survey

    Immediately after the procedure

Study Arms (4)

No intervention

NO INTERVENTION

Buzzy

EXPERIMENTAL

Thermomechanical device for periprocedural analgesia

Device: Buzzy thermomechanical device

Music Selection

EXPERIMENTAL

Patient specified music selection for procedural room

Behavioral: Music Selection

Buzzy and Music Selection

EXPERIMENTAL

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

Device: Buzzy thermomechanical deviceBehavioral: Music Selection

Interventions

Buzzy thermomechanical deviceDEVICE

Buzzy thermomechanical device placed near intervention site.

BuzzyBuzzy and Music Selection
Music SelectionBEHAVIORAL

Patient specified procedural music

Buzzy and Music SelectionMusic Selection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age

You may not qualify if:

  • prisoners, elderly, minors, pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryan Michael Cobb

Philadelphia, Pennsylvania, 19130, United States

RECRUITING

MeSH Terms

Conditions

PainAgnosiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesMental Disorders

Study Officials

  • Ryan M Cobb, MD

    Temple University Hospital

    STUDY DIRECTOR

Central Study Contacts

Ryan M Cobb, MD

CONTACT

215.707.0082ryan.cobb@tuhs.temple.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 22, 2020

Study Start

January 27, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)