CompletedNot Applicable

Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response

United States30 participantsStarted 2024-03-01

Plain-language summary

Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject can refrain from caffeinated beverages in the 6 hours prior to data collection * Subject is not currently taking any beta blockers * Subject is comfortable with a manual therapy technique where the clinician touches your face and head Exclusion Criteria: * Subject has had caffeine within 6 hours * Subject is currently taking any beta blockers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ECG Data

Timeframe: Through study completion, an average of 6 months.

ICG Data

Timeframe: Through study completion, an average of 6 months.

Depression Anxiety Stress Scale-21 (DASS-21) - Depression

Timeframe: Through study completion, an average of 6 months.

Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety

Timeframe: Through study completion, an average of 6 months.

Depression Anxiety Stress Scale-21 (DASS-21) - Stress

Timeframe: Through study completion, an average of 6 months.

Simple Physical Activity Questionnaire (SIMPAQ)

Timeframe: Through study completion, an average of 6 months.

Self Assessment Manikin (SAM) - Valence

Timeframe: Through study completion, an average of 6 months.

Trial details

NCT IDNCT06305585

SponsorUniversity of Idaho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Psychological Stress trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

ECG Data

Timeframe: Through study completion, an average of 6 months.

ICG Data

Timeframe: Through study completion, an average of 6 months.

Depression Anxiety Stress Scale-21 (DASS-21) - Depression

Timeframe: Through study completion, an average of 6 months.

Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety

Timeframe: Through study completion, an average of 6 months.

Depression Anxiety Stress Scale-21 (DASS-21) - Stress

Timeframe: Through study completion, an average of 6 months.

Simple Physical Activity Questionnaire (SIMPAQ)

Timeframe: Through study completion, an average of 6 months.

Self Assessment Manikin (SAM) - Valence

Timeframe: Through study completion, an average of 6 months.