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

Not Applicable

Active, not recruiting

• Conditions: Stress; Anxiety

• Registration Number: NCT06708715
• Lead Sponsor: SuperPatch Limited LLC

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

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 Timeline

• Study Start: 2023-05-05
• Status Verified: 2024-05
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in patient Perceived Stress Scale (PSS)	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).
Changes in patient Medical Outcomes Study Short Form-20 (SF-20)	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.
Changes in the use of prescription and OTC medications	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.
Demographics and patient satisfaction with the PEACE Patch treatment.	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.

Trial Locations

Locations (1)

Stein Medical; 🇺🇸 Tyrone, Georgia, United States