Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment (STRAVA)

December 4, 2025 updated by: SuperPatch Limited LLC
The purpose of this research study is to collect subject perceptions or feelings about their treatment. Participation includes a survey from individuals who are receiving a stress or anxiety-relieving topical patch [Super Patch PEACE Patch with Haptic Vibrotactile Trigger Technology (VTT)] and assigned to a Treatment Group or given a Sham patch, assigned to the Control Group, to address symptoms or stress and anxiety symptoms using validated scales [for example, The Perceived Stress Scale (PSS) or Medical Outcomes Study Short Form-20 (SF-20)].

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This minimal risk observational study, will evaluate an over the counter (OTC) non-invasive, non- pharmacological patch (Super Patch PEACE Patch; The Super Patch Company Ltd LLC., SRYSTY Holding Co., Toronto, Canada) that is embedded with a proprietary sensory pattern and incorporates haptic vibrotactile trigger technology (VTT) and designed to trigger neural pathways and circuits associated with stress, anxiety, and other cortical networks, with other study participants who receive an 'inactive' (Sham) patch without the embedded VTT technology. The sensory patterns within the active patches are in close symmetry between known EEG patterns and their role in modulating EEG and neuronal circuits within higher brain centers.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Tyrone, Georgia, United States, 30290
        • Stein Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ages 18 to 85, inclusive
  2. Able to provide written informed consent
  3. Have received a PEACE Patch from their treating clinician if in treatment group.
  4. Is a patient who has been diagnosed with experienced stress or anxiety related issues.
  5. Have received a Sham Patch if assigned tot eh Control Group

Exclusion Criteria:

  1. Use of drugs of abuse (illicit or prescription)
  2. Pregnancy
  3. Existing or planned implantation of Pacemaker or other electrical devices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TREATMENT
Subjects will be given a patch that incorporates a vibrotactile haptic technology (VTT) sensory pattern (PEACE Patch)
Device: PEACE Patch
A topical patch that incorporates a sensory pattern of vibrotactile haptic technology.
Sham Comparator: CONTROL
Subjects will be given a sham patch that does not incorporate vibrotactile haptic technology.
Device: Topical Sham Patch
Sham Patch that does not include vibrotactile haptic technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patient Perceived Stress Scale (PSS)
Time Frame: From enrollment to end of treatment at 2 weeks
Changes in patient Perceived Stress Scale (PSS) overall scores among and between the treated group and the control group. The Perceived Stress Scale (PSS) score is calculated by adding the score for all 10 questions, after reversing the scores for Q4, 5, 7 and 8 (0=4, 1=3, 2=2, 3=1, 4=0). Total possible score = 40. PSS categorizes stress levels as either high (scores of between 27-40), moderate (scores between 14-26), or low (scores between 0-14).
From enrollment to end of treatment at 2 weeks
Changes in patient Medical Outcomes Study Short Form-20 (SF-20)
Time Frame: From enrollment to end of treatment at 2 weeks
Changes in patient Medical Outcomes Study Short Form-20 (SF-20) for 6 domains among and between the treated group and the control group. There are 20 items and 6 domains in the SF-20 that are measured. These are Physical Functioning, Role Functioning, Social Functioning, Mental Health, Health Perceptions, and Pain. Except for the Pain domain, the higher the percentage, the better the quality-of-life is corresponding. For the Pain domain, the lower the percentage, the lower the amount of bodily pain is corresponding. For the Mental Health domain, the analysis represents the four major mental health dimensions. These are anxiety, depression, loss of behavioral-emotional control, and psychological well- being.
From enrollment to end of treatment at 2 weeks
Changes in the use of prescription and OTC medications
Time Frame: From enrollment to end of treatment at 2 weeks
Changes in Number of Prescription Medications Used based on subject and clinician reporting through a questionnaire for those subjects in Treatment Arm and receiving the active patch (PEACE) or Control Sham patch during study period. Comparisons will be made between prescription medication usage reporting at baseline, 7-day, and 14 days.
From enrollment to end of treatment at 2 weeks
Demographics and patient satisfaction with the PEACE Patch treatment.
Time Frame: From enrollment to end of treatment at 2 weeks
Demographics and patient satisfaction based on subject and clinician reporting for those subjects in Treatment Arm and receiving the active patch (PEACE) or Control Sham patch during study period.
From enrollment to end of treatment at 2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any side effects reported by patients will be documented and assessed by clinician and PI
Time Frame: From enrollment to end of treatment at 2 weeks
Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator.
From enrollment to end of treatment at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SuperPatch Limited LLC

Collaborators

Clarity Science LLC

Investigators

  • Principal Investigator: Jeffrey Gudin, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRAVA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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