Temple Massager System: Impact on Anxiety, Emotional Wellbeing, and Quality of Life in Women Aged 35-65
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Temple Massager System Users
Women aged 35 to 65 who use the Temple Massager System once daily for at least 5 minutes over a 4-week active intervention period, following a 1-week baseline observation period with no device use.
干预措施: Temple Massager System (Device)