Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Temple Massager System

Treatment groups

48 Participants
are divided into 1 treatment group

Locations

1
MOQ Collective, Ltd.94930, FairfaxCalifornia, United States

Sponsors and collaborators

MOQ Collective, Ltd

Lead sponsor

Meisch Temple Massager, Inc

Collaborator

Source ClinicalTrials.gov