Clinical Trial

The Effect of the Modified Mitchell Relaxation Method on Acute Cardiac Autonomic Modulation

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Summary
The purpose of this multi-center, randomized controlled trial is to investigate the acute effects of the standard Laura Mitchell Physiological Relaxation Method versus a Modified Mitchell Relaxation Version on cardiac autonomic modulation (heart rate variability). The study will include 122 participants aged 18-65 who score 10 or higher on the Generalized Anxiety Disorder-7 (GAD-7) scale, indicating high anxiety and potentially reduced parasympathetic control. Participants will be randomly allocated into two equal groups (n=61 per group) using a block randomization system with a concealed envelope method. To control for expectation bias, an incomplete disclosure protocol will be utilized, ensuring participants remain blinded to their specific group allocation. Both interventions will last 35 minutes and will be delivered via audio recordings in a supine position (Mitchell's 'Position A') to prevent investigator bias. Cardiac autonomic responses will be assessed using a Polar H10 chest strap to analyze Heart Rate Variability (HRV) before, during, and after the sessions. Blood pressure and respiration rate will also be monitored as secondary outcomes
Trial Details
NCT Number NCT07713407
Lead Sponsor Balikesir University
Conditions Stress and Anxiety
Enrollment 122 participants
Start Date 2026-07-01
Primary Completion 2028-07-01 (estimated)
Study Completion 2028-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-20