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

Not Applicable

Not yet recruiting

• Conditions: Psychological Stress

• Registration Number: NCT06305585
• Lead Sponsor: University of Idaho

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.

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:

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.

Study Timeline

• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study Start: 2024-03
• Study First Submitted QC: 2024-03-10
• Last Update Submitted: 2024-03-10
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety	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.
Self Assessment Manikin (SAM) - Valence	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).
ECG Data	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).
Self Assessment Manikin (SAM) - Arousal	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).
ICG Data	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	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) - Stress	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)	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.

Trial Locations

Locations (1)

ISMaRT Clinic; 🇺🇸 Moscow, Idaho, United States