Temple Massager System Study in Women Ages 35-65

N/ANot Yet RecruitingNCT07639658

MOQ Collective, Ltd48 enrolled

Overview

The goal of this observational study is to learn how the Temple Massager System affects stress, emotional wellbeing, sleep, and quality of life in women aged 35 to 65. The Temple Massager System is a non-electric, drug-free hand-held device used for self-massage of the temple area. The system also includes a body lotion and an optional lavender aromatherapy. It is sold as a general wellness product. The main questions this study aims to answer are: Does daily use of the Temple Massager System lower self-reported stress and improve emotional wellbeing over 4 weeks? Does daily use improve self-reported sleep quality and overall quality of life? This is a single-arm observational study. There is no placebo or comparison group. Researchers will compare how participants feel before they start using the device to how they feel after 4 weeks of daily use. Participants will: Receive a Temple Massager System at no cost Complete a 1-week baseline period before using the device Use the device once a day for at least 5 minutes for 4 weeks Answer short daily questions about device use, headaches, and over-the-counter medication use Complete weekly check-in surveys about stress, mood, and sleep Complete longer surveys at the start and end of the study Keep the device after the study ends The study runs for 5 weeks per participant and takes place entirely from home through a secure app-based platform. No clinic visits are required.

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.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score

The GAD-7 is a 7-item self-report questionnaire measuring emotional wellbeing on a 4-point Likert scale (0-3) per item with a 2-week recall window. Total score range: 0 to 21. Higher scores indicate greater symptom severity (worse outcome). In this study, the GAD-7 is used as a measure of subclinical emotional wellbeing, not as a diagnostic tool.

Time frame: Baseline (Day 1) to End-of-Study (Day 35)

Secondary Outcomes

Change in PROMIS Sleep Disturbance Short Form 8a T-Score

The PROMIS Sleep Disturbance Short Form 8a is an 8-item NIH-developed self-report instrument measuring sleep disturbance over the past 7 days. Scored using T-score methodology with a population mean of 50 and standard deviation of 10. T-score range typically 30 to 80. Higher T-scores indicate greater sleep disturbance (worse outcome).

Time frame: Baseline (Day 1) to End-of-Study (Day 35)

Change in PROMIS-29 Profile v2.1 Domain T-Scores

The PROMIS-29 Profile v2.1 is a 29-item NIH-developed self-report instrument measuring quality of life across 7 domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social participation. Each domain produces a T-score with a population mean of 50 and standard deviation of 10. For physical function and social participation domains, higher T-scores indicate better outcomes; for symptom domains (anxiety, depression, fatigue, sleep disturbance, pain interference), higher T-scores indicate worse outcomes.

Time frame: Baseline (Day 1) to End-of-Study (Day 35)

Change in Weekly Over-the-Counter Rescue Medication Frequency

Self-reported weekly frequency of over-the-counter pain medication use, measured as count of medication days per week (range 0 to 7 days). Lower frequency indicates a better outcome. Comparison made between the baseline week (Week 0) and the final week of the active intervention period (Week 4).

Time frame: Baseline Week (Week 0) and Final Active Week (Week 4)

Temple Massager System Study in Women Ages 35-65

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts