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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Topical Sham Patch: Sham Patch that does not include vibrotactile haptic technology

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

Eligibility

Primary outcome measure(s)

• 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 sites (1)

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