Temple Massager System Study in Women Ages 35-65

The Temple Massager System is a non-electric, drug-free, hand-held massage device intended for self-massage of the area around the temples. The system includes: The Temple Massager device with multiple attachment heads A body lotion containing mango butter, shea butter, arnica, and St. John's Wort An optional lavender essential oil for aromatherapy The Temple Massager is sold as a general wellness product. It is not a medical device. About 70 to 80 percent of buyers are women. Over 15 years of real-world use, the device has been used by combat veterans, police officers, 911 dispatchers, and healthcare workers. Many have reported benefits including lower tension, reduced stress, improved sleep, and fewer headaches. This study formalizes those personal accounts into structured, IRB-governed research. Study Design This is a single-arm, open-label, observational study. There is no placebo group and no comparison group. The study is decentralized, meaning participants take part from home and never visit a clinic. All data is collected through a secure, HIPAA-compliant, app-based study platform. The study enrolls 48 women aged 35 to 65 with a target of 40 participants completing all study activities. Study Structure Each participant moves through the following periods: Screening and Enrollment (up to 2 weeks): Participants confirm eligibility, give electronic informed consent, and provide shipping information. Shipping (up to 2 weeks): The participant receives the Temple Massager System at home. Baseline Week (Week 0, Days 1 to 7): Participants do not use the device yet. They complete starting-point surveys and begin a daily log of headaches and any over-the-counter medication use. This week sets a baseline for comparison. Active Use Period (Weeks 1 to 4, Days 8 to 35): Participants use the device once a day for at least 5 minutes, targeting the temple area. Each day they complete a short log covering device use, headaches, and medication use. End-of-Study Assessments (Days 35 to 38): Participants complete the same starting-point surveys again, plus a satisfaction survey. The total study duration is 5 weeks per participant. Participants keep the device after the study and receive a $25 gift card for completing end-of-study assessments. Measures Used The study uses validated, widely used self-report tools: Generalized Anxiety Disorder 7-item Scale (GAD-7): Used in this study as a measure of emotional wellbeing and subclinical stress symptoms. Not used as a diagnostic tool. PROMIS Sleep Disturbance Short Form 8a: Measures sleep quality. PROMIS-29 Profile v2.1: Measures quality of life across 7 areas including physical function, emotional wellbeing, fatigue, sleep, pain interference, and social participation. Weekly pulse measures: GAD-2 and PHQ-2 short scales, plus visual rating scales for stress and sleep quality. Daily logs: device use, headache occurrence and intensity, and over-the-counter medication use. Aromatherapy Sensitivity Note About 10 to 15 percent of people are sensitive to lavender oil. All participants will perform a small patch test on the inner wrist before first using the aromatherapy component. Anyone who experiences irritation will stop the aromatherapy and continue with just the device and lotion. Lavender sensitivity does not exclude participants from the study. Primary Outcome Change in GAD-7 total score from baseline (Day 1) to end-of-study (Day 35). Why This Study Few self-administered wellness products have been studied through structured, IRB-reviewed research. Findings from this study will contribute knowledge about the real-world effects of regular massage device use on stress, emotional wellbeing, sleep, and quality of life, and will help inform the design of future research.