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

NCT06708715 | Active Not Recruiting

• 1 other identifier: STRAVA-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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 \[for example, The Perceived Stress Scale (PSS) or Medical Outcomes Study Short Form-20 (SF-20)\].

Conditions

Stress; Anxiety

Keywords

stress; anxiety; SuperPatch; PEACE Patch; Haptic; Vibrotactile Haptic Technology; VTT

Outcome Measures

Primary Outcomes (4)

• Changes in patient Perceived Stress Scale (PSS)

  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)

  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

  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.

  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 Outcomes (1)

• Any side effects reported by patients will be documented and assessed by clinician and PI

  From enrollment to end of treatment at 2 weeks

Study Arms (2)

TREATMENT

ACTIVE COMPARATOR

Subjects will be given a patch that incorporates a vibrotactile haptic technology (VTT) sensory pattern (PEACE Patch)

Device: PEACE Patch

CONTROL

SHAM COMPARATOR

Subjects will be given a sham patch that does not incorporate vibrotactile haptic technology.

Device: Topical Sham Patch

Interventions

PEACE Patch DEVICE

A topical patch that incorporates a sensory pattern of vibrotactile haptic technology.

TREATMENT

Topical Sham Patch DEVICE

Sham Patch that does not include vibrotactile haptic technology

CONTROL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Male and Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of drugs of abuse (illicit or prescription)
• Pregnancy
• Existing or planned implantation of Pacemaker or other electrical devices

Sponsors & Collaborators

• SuperPatch Limited LLC: lead
• Clarity Science LLC: collaborator

Study Sites (1)

Stein Medical

Tyrone, Georgia, 30290, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jeffrey Gudin, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: May 5, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)