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.

Inclusion criteria

• Female, aged 35-65 years old, inclusive
• Self-reported experience of daily stress, anxiety, tension headaches, facial tension, or TMJ-related discomfort
• Headache frequency of 2 or more per week (self-reported)
• If taking any prescription medication including SSRIs, anxiolytics, sleep medications, hormonal therapies, or blood pressure medications, must be on a stable dose for at least 4 weeks prior to study enrollment and throughout the course of the study
• In good general health at the time of screening (Investigator discretion)
• Able to read and understand English
• Able to read, understand, and provide informed consent
• Able to use a personal smartphone or tablet and access the study platform for daily data entry
• Able to receive shipment of the study product at an address within the United States
• Willing and able to use the Temple Massager System daily for 4 weeks

Exclusion criteria

• No personal smartphone or tablet, no internet access, or unwilling to use the study platform
• Known allergy or sensitivity to lavender oil, mango butter, shea butter, arnica, or St. John's Wort (Note: lavender sensitivity alone is not exclusionary; an aromatherapy sensitivity protocol applies)
• Active skin infection or open wounds on the face or temple area
• Diagnosed trigeminal neuralgia or other cranial nerve pathology
• Diagnosed vascular issues affecting the head or face: temporal arteritis, aneurysm, or cerebrovascular malformations
• Bleeding disorders: history of easy bruising or bleeding in the face/head area, or current use of prescribed blood thinners (anticoagulants) such as Warfarin or Eliquis
• Any surgery on the jaw, temples, or face within the last 6 months
• Active inflammation: current redness, swelling, or extreme tenderness specifically over the temple arteries
• Current use of prescription headache medications (triptans, topiramate, muscle relaxants, beta-blockers for migraine prophylaxis, or other prescription medications taken primarily for headache management)
• Participants currently taking any prescribed medication for sleep or anxiety must be on a stable dose (no dose changes within the past 30 days) to be eligible; participants not on a stable dose are excluded
• Current participation in another interventional study
• Diagnosed Generalized Anxiety Disorder (GAD)
• Currently pregnant, planning to become pregnant during the study period, or breastfeeding
• Planned surgical procedure during the study period
• Significant illness, disease, or condition which, in the opinion of the Principal Investigator, may impact the ability to participate in the study or impact the study outcomes
• Unlikely for any reason to be able to comply with the study or considered unsuited for participation by the Principal Investigator