Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305585
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-28
Brief Title:
Can a Novel Manual Therapy Technique Help Relieve Stress Assessing Effects of Primal Reflex Release on the Bodys Stress Response
Sponsor:
University of Idaho
Organization:
University of Idaho
Study Overview
Official Title:
Can a Manual Therapy Technique Help Relieve Stress Assessing Effects of Primal Reflex Release on the Bodys Stress Response
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 prepost 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
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 prepost 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None