Temple Massager System Study in Women Ages 35-65
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35-65
SponsorMOQ Collective, Ltd
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
This trial accepts healthy volunteersQualifiers
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 population
Women aged 35 to 65 who experience daily stress, anxiety, tension headaches, facial tension, or TMJ-related discomfort, with self-reported headache frequency of two or more per week. Participants must be in good general health, on stable medication regimens if applicable, able to use a personal smartphone or tablet, and willing to use the Temple Massager System daily for 4 weeks. Participants are recruited nationwide through wellness research participant pools, social media advertising, and targeted digital outreach to women in wellness communities.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Temple Massager System
DeviceA 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Temple Massager System Users1 intervention
Trial outcomes
Primary outcomes
1
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
1
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)2
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)3
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)Other outcomes
1
Change in Generalized Anxiety Disorder 2-item Scale (GAD-2) Score
The GAD-2 is a 2-item self-report screening instrument for anxiety symptoms, scored on a 4-point Likert scale (0-3) per item. Total score range: 0 to 6. Higher scores indicate greater symptom severity (worse outcome). Administered as a weekly pulse measure.
Time frame
Weekly at Weeks 0 through 42
Change in Patient Health Questionnaire 2-item Scale (PHQ-2) Score
The PHQ-2 is a 2-item self-report screening instrument for depression symptoms, scored on a 4-point Likert scale (0-3) per item. Total score range: 0 to 6. Higher scores indicate greater symptom severity (worse outcome). Administered as a weekly pulse measure.
Time frame
Weekly at Weeks 0 through 43
Change in Self-Reported Stress Visual Analogue Scale (VAS) Score
Self-reported stress level measured using a Visual Analogue Scale ranging from 0 (no stress) to 10 (extreme stress). Higher scores indicate greater stress (worse outcome). Administered as a weekly pulse measure.
Time frame
Weekly at Weeks 0 through 44
Change in Self-Reported Sleep Quality Visual Analogue Scale (VAS) Score
Self-reported sleep quality measured using a Visual Analogue Scale ranging from 0 (worst sleep quality) to 10 (best sleep quality). Higher scores indicate better sleep quality (better outcome). Administered as a weekly pulse measure.
Time frame
Weekly at Weeks 0 through 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MOQ Collective, Ltd
Lead sponsor
Meisch Temple Massager, Inc
Collaborator
Source ClinicalTrials.gov
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