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

Psychological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06305585
• Other study ID #: IRB# 23-214
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: University of Idaho
• Contact: Nickolai J Martonick, PhD
• Phone: (208) 885-8749
• Email: nmartonick[@]uidaho.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

1. Pre-intervention during a 5-minute video of aquatic nature scenes to establish resting baseline

2. 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

3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	ISMaRT Clinic	Moscow	Idaho

Sponsors (4)

Lead Sponsor	Collaborator
University of Idaho	CJ Brush, Jayme Baker, Sydney Leverett

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.