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

ConditionStress and Anxiety
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

This trial accepts healthy volunteers

Qualifiers

Being 18-65 years old.

Having stress and anxiety

Disqualifiers

Taking cardioactive/psychotropic drugs.

Having a diagnosis of cardiovascular disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Mitchell Relaxation Exercises

    Other intervention

    Modified Relaxation Exercises based on Muscle Energy Technique, Deep Breathing, Additional Natural Relxation Postures in addition Skin and Proprioceptive Awareness and Reciprocal Mussle .

  • Standard Mitchell Relaxation Exercise

    Other intervention

    Original Relaxation Exercises based on Skin and Proprioceptive Awareness and Reciprocal Mussle Inhibition

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Standard Laura Mitchell ExercisesExperimental treatment 1 intervention
Group B: Modified Mitchell ExercisesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RMSSD - Root Mean Square of Succesive Differences of RR Peaks of EKG

Root Mean Square of Succesive Differences of RR Peaks of EKG

Time frame
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.

Secondary outcomes

1

Time-Domain Heart Rate Variability Parameters (SDNN, RMSSD, Mean RR Interval)

Time-domain HRV parameters, including the standard deviation of NN intervals (SDNN), the root mean square of successive differences between normal heartbeats (RMSSD), and mean RR interval duration, will be calculated from continuous ECG/PPG recordings. \[Unit: milliseconds\]

Time frame
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
2

Absolute Spectral Power HRV Parameters (LF, HF)

Low-frequency (LF, 0.04-0.15 Hz) and high-frequency (HF, 0.15-0.4 Hz) spectral power components of heart rate variability will be calculated from RR interval series using power spectral density analysis. \[Unit: ms²\]

Time frame
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
3

LF/HF Ratio

The ratio of low-frequency to high-frequency spectral power, reflecting sympathovagal balance, will be calculated from RR interval series. \[Unit: ratio (unitless)\]

Time frame
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
4

Poincaré Plot HRV Parameters (SD1, SD2)

Standard deviation of the Poincaré plot perpendicular to the line of identity (SD1) and along the line of identity (SD2), reflecting short- and long-term heart rate variability, will be calculated from RR interval series. \[Unit: milliseconds\]

Time frame
During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Balikesir University

Lead sponsor

Source ClinicalTrials.gov

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