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Behavioural Intervention

PEACE Patch for Stress and Anxiety (STRAVA Trial)

N/A
Waitlist Available
Led By Jeffrey Gudin, MD
Research Sponsored by SuperPatch Limited LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18 to 85, inclusive
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment at 2 weeks

Summary

This trial aims to gather feedback from individuals using a stress or anxiety-relieving patch. Participants will complete a survey to share their thoughts on the treatment they received. They may either use the actual patch or

Who is the study for?
This trial is for individuals experiencing stress or anxiety who are interested in testing a topical patch designed to relieve these symptoms. Participants will be asked to complete surveys about their feelings using validated scales.
What is being tested?
The study tests the PEACE Patch, which uses Haptic Vibrotactile Trigger Technology, against a sham (placebo) patch. Participants will be randomly assigned to either the treatment group with the real patch or control group with the sham.
What are the potential side effects?
Since this trial involves non-invasive patches, side effects may include skin irritation at the site of application. However, detailed side effects are not provided and would depend on individual reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of treatment at 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of treatment at 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in patient Medical Outcomes Study Short Form-20 (SF-20)
Changes in patient Perceived Stress Scale (PSS)
Changes in the use of prescription and OTC medications
+1 more
Other study objectives
Any side effects reported by patients will be documented and assessed by clinician and PI

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TREATMENTActive Control1 Intervention
Subjects will be given a patch that incorporates a vibrotactile haptic technology (VTT) sensory pattern (PEACE Patch)
Group II: CONTROLPlacebo Group1 Intervention
Subjects will be given a sham patch that does not incorporate vibrotactile haptic technology.

Find a Location

Who is running the clinical trial?

SuperPatch Limited LLCLead Sponsor
2 Previous Clinical Trials
250 Total Patients Enrolled
Clarity Science LLCUNKNOWN
2 Previous Clinical Trials
250 Total Patients Enrolled
Jeffrey Gudin, MDPrincipal InvestigatorUniversity of Miami
~7 spots leftby Feb 2025
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