Temple Massager System Study in Women Ages 35-65

NCT07639658 | Not Yet Recruiting

• 2 other identifiers: MOQ-TM-2026-0116370
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tension Headaches; Stress; Sleep Quality; Quality of Life

Keywords

Stress relief; Wellness; Massage device; Temple massage; Facial tension; Relaxation; Women's Health; Decentralized trial; Observational study

Outcome Measures

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.

  Baseline (Day 1) to End-of-Study (Day 35)

Secondary Outcomes (3)

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

  Baseline (Day 1) to End-of-Study (Day 35)

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

  Baseline (Day 1) to End-of-Study (Day 35)

• Change in Weekly Over-the-Counter Rescue Medication Frequency

  Baseline Week (Week 0) and Final Active Week (Week 4)

Other Outcomes (5)

• Change in Generalized Anxiety Disorder 2-item Scale (GAD-2) Score

  Weekly at Weeks 0 through 4

• Change in Patient Health Questionnaire 2-item Scale (PHQ-2) Score

  Weekly at Weeks 0 through 4

• Change in Self-Reported Stress Visual Analogue Scale (VAS) Score

  Weekly at Weeks 0 through 4

Study Arms (1)

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.

Device: Temple Massager System

Interventions

Temple Massager System DEVICE

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.

Temple Massager System Users

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• No personal smartphone or tablet, no internet access, or unwilling to use the study platform
• 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

Sponsors & Collaborators

• MOQ Collective, Ltd: lead
• Meisch Temple Massager, Inc: collaborator

Study Sites (1)

MOQ Collective, Ltd.

Fairfax, California, 94930, United States

Location

Related Publications (3)

• Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.

  PMID: 22250775 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Colleen Quinn

  MOQ Collective, Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan L Morris, CNC

CONTACT

415-320-0000; contact@moqcollective.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 10, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)