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COMPLETED

NCT07639658

Temple Massager System Study in Women Ages 35-65

Sponsor: MOQ Collective, Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: Temple Massager System: Impact on Anxiety, Emotional Wellbeing, and Quality of Life in Women Aged 35-65

Key Details

Gender

FEMALE

Age Range

35 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-06-10

Completion Date

2026-07-31

Last Updated

2026-09-04

Healthy Volunteers

Yes

Conditions

Tension Headaches Stress Sleep Quality Quality of Life

Interventions

DEVICE

Temple Massager System

A non-electric, drug-free, hand-held mechanical massage wellness device used for self-massage of the temple region. The system includes the device with multiple attachment heads, a body lotion containing mango butter, shea butter, arnica, and St. John's Wort, and an optional lavender essential oil aromatherapy component. Participants use the device once daily for at least 5 minutes over a 4-week active intervention period. The Temple Massager System is a commercially available general wellness product.

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

Locations (1)

MOQ Collective, Ltd.

Fairfax, California, United States