Psychological StressNCT06305585
Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response
A study testing Primal Reflex Release Technique (PRRT) in people with Psychological Stress, run by University of Idaho at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Primal Reflex Release Technique (PRRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Jun 2024
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Subject has had caffeine within 6 hours
- Subject is currently taking any beta blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can a Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response
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.
Read the detailed description
This randomized, controlled experimental intervention study evaluates acute impacts of a reflex-targeted manual therapy called Primal Reflex Release Technique (PRRT) on cardiovascular indices of stress and sympathetic tone. After consenting and baseline characteristics, subjects are allocated to receive either the PRRT or the control condition.
Continuous electrocardiography (ECG) and impedance cardiography (ICG) monitoring will be used to track heart rate variability (HRV) changes across three phases:
- Pre-intervention during a 5-minute video of aquatic nature scenes to establish resting baseline
- 5 minutes of a practitioner administering targeted spinal manipulation PRRT protocol in the treatment group to stimulate innate protective reflexes OR continued relaxation video viewing for control group
- Post-intervention repeat of the standardized video to assess changes after PRRT session without ongoing manipulation
The PRRT targets precise anatomical locations and neural pathways including stimulating facial muscles, upper spinal reflexes and traction of the suboccipital muscles. Brief, reversible sensations will occur without expected harm or lasting effects.
Psychological state assessed via paper mood scales pre/post tracks subjective stress correlates. Analysis using linear mixed effects models contrast whether indices of cardiovascular reactivity and psychological responses shift acutely with PRRT versus control video. Findings could provide physiological validation for integration as stress-alleviating treatment.
- Conditions
- Psychological Stress
- Being tested
- Primal Reflex Release Technique (PRRT)
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primal Reflex Release Technique (PRRT)Other
Primal Reflex Release Technique (PRRT) is a non-invasive complementary hands-on treatment method intended to help relax the central nervous system by gently stimulating innate protective reflexes. A certified practitioner applies light tactile stimulation to targeted areas in a structured sequence postulated to help release hypertonic muscles, restore regulation of automatic responses, and enable a calm, parasympathetic state.
| Study group | Role | What they receive |
|---|---|---|
| Primal Reflex Release Technique | Experimental | The subject will lay on their back with their eyes closed. Palmar Reflex Release The subject will actively raise arms overhead (palm facing the floor) with a pen squeezed between their fingers.
Epicranial Release The clinician will grasp the subject's hair near the front of the hairline with one hand, just above the ear on the right side and gently pull.
Frontalis Release The clinician will instruct the subject to raise their eyebrows and keep them raised. The clinician will use their thumbs to gently flick downward on the inside portion of the subject's eyebrows.
Orbicularis Oculi Release The clinician will place their thumb below the eye resting on the cheek bone and with the other hand will lightly rest on the subject's eyelid The clinician will then gently and lightly attempt to quickly open the subject's eyelids
Suboccipital Release The participant will rest their head in clinicians hands while they provide a slight traction at the base of the skull Receives: Other: Primal Reflex Release Technique (PRRT) |
| Control | No intervention | For the control, the subject will watch another 5-minute video of fish in an aquarium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG Data
ECG will be used to derive respiratory sinus arrythmia (RSA), which will be derived as the natural-logged spectral power value in the high-frequency bandwidth (0.15-0.40 Hz).
Measured: Through study completion, an average of 6 months.
ICG Data
ICG will be used to derive pre-ejection period (PEP), which represents the time between the onset of ventricular depolarization and the opening of the aortic valve.
Measured: Through study completion, an average of 6 months.
Depression Anxiety Stress Scale-21 (DASS-21) - Depression
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. Scores for depression are calculated by summing the scores for the relevant items (0-42) with higher scores indicating greater levels of depression.
Measured: Through study completion, an average of 6 months.
Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. Scores for anxiety are calculated by summing the scores for the relevant items (0-42) with higher scores indicating greater levels of anxiety.
Measured: Through study completion, an average of 6 months.
Depression Anxiety Stress Scale-21 (DASS-21) - Stress
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for stress are calculated by summing the scores for the relevant items (0-42) with higher scores indicating greater stress.
Measured: Through study completion, an average of 6 months.
Simple Physical Activity Questionnaire (SIMPAQ)
The SIMPAQ is used to determine the average amount of time that participants spend exercising per day.
Measured: Through study completion, an average of 6 months.
Self Assessment Manikin (SAM) - Valence
Assessment of valence ranging on a 9-point scale from 1 (feeling pleasant) to 9 (feeling unpleasant).
Measured: Through study completion, an average of 6 months.
Self Assessment Manikin (SAM) - Arousal
Assessment of arousal ranging on a 9-point scale from 1 (feeling excited) to 9 (feeling calm).
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nickolai Martonick, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305585
- Sponsor's protocol ID
- IRB# 23-214
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response
- ClinicalTrials.gov ID
- NCT06305585
- Acronym / sponsor ID
- IRB# 23-214
- Conditions
- Psychological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 12 Mar 2024 (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.
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.
Detailed description
This randomized, controlled experimental intervention study evaluates acute impacts of a reflex-targeted manual therapy called Primal Reflex Release Technique (PRRT) on cardiovascular indices of stress and sympathetic tone. After consenting and baseline characteristics, subjects are allocated to receive either the PRRT or the control condition.
Continuous electrocardiography (ECG) and impedance cardiography (ICG) monitoring will be used to track heart rate variability (HRV) changes across three phases:
- Pre-intervention during a 5-minute video of aquatic nature scenes to establish resting baseline
- 5 minutes of a practitioner administering targeted spinal manipulation PRRT protocol in the treatment group to stimulate innate protective reflexes OR continued relaxation video viewing for control group
- Post-intervention repeat of the standardized video to assess changes after PRRT session without ongoing manipulation
The PRRT targets precise anatomical locations and neural pathways including stimulating facial muscles, upper spinal reflexes and traction of the suboccipital muscles. Brief, reversible sensations will occur without expected harm or lasting effects.
Psychological state assessed via paper mood scales pre/post tracks subjective stress correlates. Analysis using linear mixed effects models contrast whether indices of cardiovascular reactivity and psychological responses shift acutely with PRRT versus control video. Findings could provide physiological validation for integration as stress-alleviating treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primal Reflex Release Technique | Experimental | Other: Primal Reflex Release Technique (PRRT)The subject will lay on their back with their eyes closed. Palmar Reflex Release The subject will actively raise arms overhead (palm facing the floor) with a pen squeezed between their fingers. Epicranial Release The clinician will grasp the subject's hair near the front of the hairline with one hand, just above the ear on the right side and gently pull. Frontalis Release The clinician will instruct the subject to raise their eyebrows and keep them raised. The clinician will use their thumbs to gently flick downward on the inside portion of the subject's eyebrows. Orbicularis Oculi Release The clinician will place their thumb below the eye resting on the cheek bone and with the other hand will lightly rest on the subject's eyelid The clinician will then gently and lightly attempt to quickly open the subject's eyelids Suboccipital Release The participant will rest their head in clinicians hands while they provide a slight traction at the base of the skull |
| Control | No intervention | –For the control, the subject will watch another 5-minute video of fish in an aquarium. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subject has had caffeine within 6 hours
- Subject is currently taking any beta blockers
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 |
|---|---|---|
| Primal Reflex Release Technique (PRRT)Primal Reflex Release Technique (PRRT) is a non-invasive complementary hands-on treatment method intended to help relax the central nervous system by gently stimulating innate protective reflexes. A certified practitioner applies light tactile stimulation to targeted areas in a structured sequence postulated to help release hypertonic muscles, restore regulation of automatic responses, and enable a calm, parasympathetic state. | Other | Primal Reflex Release Technique |
Primary outcome
ECG Data
Time frame: Through study completion, an average of 6 months.
ECG will be used to derive respiratory sinus arrythmia (RSA), which will be derived as the natural-logged spectral power value in the high-frequency bandwidth (0.15-0.40 Hz).
ICG Data
Time frame: Through study completion, an average of 6 months.
ICG will be used to derive pre-ejection period (PEP), which represents the time between the onset of ventricular depolarization and the opening of the aortic valve.
Depression Anxiety Stress Scale-21 (DASS-21) - Depression
Time frame: Through study completion, an average of 6 months.
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. Scores for depression are calculated by summing the scores for the relevant items (0-42) with higher scores indicating greater levels of depression.
Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety
Time frame: Through study completion, an average of 6 months.
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. Scores for anxiety are calculated by summing the scores for the relevant items (0-42) with higher scores indicating greater levels of anxiety.
Depression Anxiety Stress Scale-21 (DASS-21) - Stress
Time frame: Through study completion, an average of 6 months.
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for stress are calculated by summing the scores for the relevant items (0-42) with higher scores indicating greater stress.
Simple Physical Activity Questionnaire (SIMPAQ)
Time frame: Through study completion, an average of 6 months.
The SIMPAQ is used to determine the average amount of time that participants spend exercising per day.
Self Assessment Manikin (SAM) - Valence
Time frame: Through study completion, an average of 6 months.
Assessment of valence ranging on a 9-point scale from 1 (feeling pleasant) to 9 (feeling unpleasant).
Self Assessment Manikin (SAM) - Arousal
Time frame: Through study completion, an average of 6 months.
Assessment of arousal ranging on a 9-point scale from 1 (feeling excited) to 9 (feeling calm).
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 4 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primal Reflex Release Technique (PRRT) in people with Psychological Stress, run by University of Idaho 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 3 inclusion and 2 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 4 May 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?
ECG Data (time frame: Through study completion, an average of 6 months.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.