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

NCT06305585 | Completed

• 1 other identifier: IRB# 23-214
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Stress

Outcome Measures

Primary Outcomes (8)

• 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).

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  Through study completion, an average of 6 months.

Study Arms (2)

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

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.

Interventions

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.

Primal Reflex Release Technique

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subject has had caffeine within 6 hours
• Subject is currently taking any beta blockers

Sponsors & Collaborators

• University of Idaho: lead

Study Sites (1)

ISMaRT Clinic

Moscow, Idaho, 83843, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)