PainNCT04236674
Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
A study testing Buzzy thermomechanical device and Music Selection in people with Pain and Analgesia, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- What is being tested?
- Buzzy thermomechanical device and Music Selection
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-90 years of age
Who cannot join
- prisoners, elderly, minors, pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ryan Michael Cobb
Philadelphia, Pennsylvania, 19130
Ryan M Cobb, MD, 215-707-0082, ryan.cobb@tuhs.temple.edu
Pratik Patel, DO, 215.707.0082, Pratik.patel@tuhs.temple.edu
About this study
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.
Read the 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.
- Being tested
- Buzzy thermomechanical device, Music Selection
- Keywords
- Distraction, Thermomechanical analgesia, Music, Anxiety, Pain, Analgesia, Buzzy, Interventional radiology, IR, Picc, Paracentesis
- Medical subject headings
- Pain, Agnosia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy thermomechanical deviceDevice
Buzzy thermomechanical device placed near intervention site.
Music SelectionBehavioural
Patient specified procedural music
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| Buzzy | Experimental | Thermomechanical device for periprocedural analgesia Receives: Device: Buzzy thermomechanical device |
| Music Selection | Experimental | Patient specified music selection for procedural room Receives: Behavioral: Music Selection |
| Buzzy and Music Selection | Experimental | A combination of use of the Buzzy device and patient specified music selection Receives: Device: Buzzy thermomechanical device; Behavioral: Music Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analog scale - pre-procedure
VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
Measured: 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
Measured: 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
Measured: Immediately after the procedure
Anxiety visual analog scale - post-procedure
VAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
Measured: Immediately after the procedure
Secondary outcomes (1)
Satisfaction survey
Patient reported satisfaction survey post-procedure
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start27 Jan 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan M Cobb, MD, Study director, Temple University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236674
- Sponsor's protocol ID
- TempleU25969
- Status last verified
- Oct 2020
- First submitted
- 16 Jan 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermomechanical Distraction and Social Anesthesia in Interventional Radiology to Improve Patient Satisfaction
- ClinicalTrials.gov ID
- NCT04236674
- Acronym / sponsor ID
- TempleU25969
- Keywords
- Distraction, Thermomechanical analgesia, Music, Anxiety, Pain, Analgesia, Buzzy, Interventional radiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| Buzzy | Experimental | Device: Buzzy thermomechanical deviceThermomechanical device for periprocedural analgesia |
| Music Selection | Experimental | Behavioral: Music SelectionPatient specified music selection for procedural room |
| Buzzy and Music Selection | Experimental | Device: Buzzy thermomechanical device, Behavioral: Music SelectionA combination of use of the Buzzy device and patient specified music selection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-90 years of age
Key exclusion criteria (1 listed)
- prisoners, elderly, minors, pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buzzy thermomechanical deviceBuzzy thermomechanical device placed near intervention site. | Device | Buzzy, Buzzy and Music Selection |
| Music SelectionPatient specified procedural music | Behavioural | Buzzy and Music Selection, Music Selection |
Primary outcome
Pain visual analog scale - pre-procedure
Time frame: Baseline (Prior to the procedure)
VAS pre-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
Anxiety visual analog scale - pre-procedure
Time frame: Baseline (Prior to the procedure)
VAS pre-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
Pain visual analog scale - post-procedure
Time frame: Immediately after the procedure
VAS post-procedure , patient reported, rated 0-100mm with 100mm as the most pain imaginable
Anxiety visual analog scale - post-procedure
Time frame: Immediately after the procedure
VAS post-procedure, patient reported, rated 0-100mm with 100mm as the Worst anxiety
1 secondary outcome
Satisfaction survey
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan M Cobb, MD study director
Temple University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy thermomechanical device and Music Selection in people with Pain and Analgesia, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan M Cobb, MD (215.707.0082, ryan.cobb@tuhs.temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain visual analog scale - pre-procedure (time frame: Baseline (Prior to the procedure)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.