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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBalikesir University

About this trial

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

Eligibility criteria

Qualifiers

Being 18-65 years old.

Having stress and anxiety

Disqualifiers

Taking cardioactive/psychotropic drugs.

Having a diagnosis of cardiovascular disease.

Trial design

Treatments tested in this trial

  • Modified Mitchell Relaxation Exercises
  • Standard Mitchell Relaxation Exercise

Treatment groups

122 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators