Clinical trial NCT06305585: Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response
Official title: Can a Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Stress
Lead sponsor: University of Idaho
Sponsor class: OTHER
Collaborators: name: CJ Brush
name: Jayme Baker
name: Sydney Leverett
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ECG Data
timeFrame: Through study completion, an average of 6 months.
measure: ICG Data
timeFrame: Through study completion, an average of 6 months.
measure: Depression Anxiety Stress Scale-21 (DASS-21) - Depression
timeFrame: Through study completion, an average of 6 months.
measure: Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety
timeFrame: Through study completion, an average of 6 months.
measure: Depression Anxiety Stress Scale-21 (DASS-21) - Stress
timeFrame: Through study completion, an average of 6 months.
measure: Simple Physical Activity Questionnaire (SIMPAQ)
timeFrame: Through study completion, an average of 6 months.
measure: Self Assessment Manikin (SAM) - Valence
timeFrame: Through study completion, an average of 6 months.
measure: Self Assessment Manikin (SAM) - Arousal
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: United States
facility: ISMaRT Clinic
state: Idaho
Study officials:
References: