Tension HeadachesNCT07639658
Temple Massager System Study in Women Ages 35-65
An observational study of Tension Headaches and Stress, run by Meisch Temple Massager, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tension Headaches, Stress, Sleep Quality
- What is being tested?
- Temple Massager System
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temple Massager System: Impact on Anxiety, Emotional Wellbeing, and Quality of Life in Women Aged 35-65
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.
Read more
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.
Read the detailed description
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.
The study enrolls 48 women aged 35 to 65 with a target of 40 participants completing all study activities.
Study Structure
Each participant moves through the following periods:
Screening and Enrollment (up to 2 weeks): Participants confirm eligibility, give electronic informed consent, and provide shipping information.
Shipping (up to 2 weeks): The participant receives the Temple Massager System at home.
Baseline Week (Week 0, Days 1 to 7): Participants do not use the device yet. They complete starting-point surveys and begin a daily log of headaches and any over-the-counter medication use. This week sets a baseline for comparison.
Active Use Period (Weeks 1 to 4, Days 8 to 35): Participants use the device once a day for at least 5 minutes, targeting the temple area. Each day they complete a short log covering device use, headaches, and medication use.
End-of-Study Assessments (Days 35 to 38): Participants complete the same starting-point surveys again, plus a satisfaction survey.
The total study duration is 5 weeks per participant. Participants keep the device after the study and receive a $25 gift card for completing end-of-study assessments.
Measures Used
The study uses validated, widely used self-report tools:
Generalized Anxiety Disorder 7-item Scale (GAD-7): Used in this study as a measure of emotional wellbeing and subclinical stress symptoms. Not used as a diagnostic tool.
PROMIS Sleep Disturbance Short Form 8a: Measures sleep quality. PROMIS-29 Profile v2.1: Measures quality of life across 7 areas including physical function, emotional wellbeing, fatigue, sleep, pain interference, and social participation.
Weekly pulse measures: GAD-2 and PHQ-2 short scales, plus visual rating scales for stress and sleep quality.
Daily logs: device use, headache occurrence and intensity, and over-the-counter medication use.
Aromatherapy Sensitivity Note About 10 to 15 percent of people are sensitive to lavender oil. All participants will perform a small patch test on the inner wrist before first using the aromatherapy component. Anyone who experiences irritation will stop the aromatherapy and continue with just the device and lotion. Lavender sensitivity does not exclude participants from the study.
Primary Outcome Change in GAD-7 total score from baseline (Day 1) to end-of-study (Day 35). Why This Study Few self-administered wellness products have been studied through structured, IRB-reviewed research. Findings from this study will contribute knowledge about the real-world effects of regular massage device use on stress, emotional wellbeing, sleep, and quality of life, and will help inform the design of future research.
- Conditions
- Tension Headaches, Stress, Sleep Quality, Quality of Life
- Being tested
- Temple Massager System
- Keywords
- Stress relief, Wellness, Massage device, Temple massage, Facial tension, Relaxation, Women's Health, Decentralized trial, Observational study
- Medical subject headings
- Tension-Type Headache, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temple Massager SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Temple Massager System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) to End-of-Study (Day 35)
Secondary outcomes (3)
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).
Measured: Baseline (Day 1) to End-of-Study (Day 35)
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.
Measured: Baseline (Day 1) to End-of-Study (Day 35)
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).
Measured: Baseline Week (Week 0) and Final Active Week (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start10 Jun 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tension HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meisch Temple Massager, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colleen Quinn, Principal investigator, MOQ Collective, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639658
- Sponsor's protocol ID
- MOQ-TM-2026-01
- Other IDs
- 16370
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22250775Cella 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.
PubMed 20685078Spitzer 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.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temple Massager System: Impact on Anxiety, Emotional Wellbeing, and Quality of Life in Women Aged 35-65
- ClinicalTrials.gov ID
- NCT07639658
- Acronym / sponsor ID
- MOQ-TM-2026-01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Meisch Temple Massager, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The study enrolls 48 women aged 35 to 65 with a target of 40 participants completing all study activities.
Study Structure
Each participant moves through the following periods:
Screening and Enrollment (up to 2 weeks): Participants confirm eligibility, give electronic informed consent, and provide shipping information.
Shipping (up to 2 weeks): The participant receives the Temple Massager System at home.
Baseline Week (Week 0, Days 1 to 7): Participants do not use the device yet. They complete starting-point surveys and begin a daily log of headaches and any over-the-counter medication use. This week sets a baseline for comparison.
Active Use Period (Weeks 1 to 4, Days 8 to 35): Participants use the device once a day for at least 5 minutes, targeting the temple area. Each day they complete a short log covering device use, headaches, and medication use.
End-of-Study Assessments (Days 35 to 38): Participants complete the same starting-point surveys again, plus a satisfaction survey.
The total study duration is 5 weeks per participant. Participants keep the device after the study and receive a $25 gift card for completing end-of-study assessments.
Measures Used
The study uses validated, widely used self-report tools:
Generalized Anxiety Disorder 7-item Scale (GAD-7): Used in this study as a measure of emotional wellbeing and subclinical stress symptoms. Not used as a diagnostic tool.
PROMIS Sleep Disturbance Short Form 8a: Measures sleep quality. PROMIS-29 Profile v2.1: Measures quality of life across 7 areas including physical function, emotional wellbeing, fatigue, sleep, pain interference, and social participation.
Weekly pulse measures: GAD-2 and PHQ-2 short scales, plus visual rating scales for stress and sleep quality.
Daily logs: device use, headache occurrence and intensity, and over-the-counter medication use.
Aromatherapy Sensitivity Note About 10 to 15 percent of people are sensitive to lavender oil. All participants will perform a small patch test on the inner wrist before first using the aromatherapy component. Anyone who experiences irritation will stop the aromatherapy and continue with just the device and lotion. Lavender sensitivity does not exclude participants from the study.
Primary Outcome Change in GAD-7 total score from baseline (Day 1) to end-of-study (Day 35). Why This Study Few self-administered wellness products have been studied through structured, IRB-reviewed research. Findings from this study will contribute knowledge about the real-world effects of regular massage device use on stress, emotional wellbeing, sleep, and quality of life, and will help inform the design of future research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temple Massager System Users | – | Device: Temple Massager SystemWomen 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temple Massager SystemA 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. | Device | Temple Massager System Users |
Primary outcome
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score
Time frame: Baseline (Day 1) to End-of-Study (Day 35)
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.
3 secondary outcomes
Change in PROMIS Sleep Disturbance Short Form 8a T-Score
Time frame: Baseline (Day 1) to End-of-Study (Day 35)
Change in PROMIS-29 Profile v2.1 Domain T-Scores
Time frame: Baseline (Day 1) to End-of-Study (Day 35)
Change in Weekly Over-the-Counter Rescue Medication Frequency
Time frame: Baseline Week (Week 0) and Final Active Week (Week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 22250775Yu 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.
- Background: PubMed 20685078Cella 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.
- Background: PubMed 16717171Spitzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Quinn principal investigator
MOQ Collective, Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tension Headaches and Stress, run by Meisch Temple Massager, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score (time frame: Baseline (Day 1) to End-of-Study (Day 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07639658, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.