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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
122
Modified Relaxation Exercises based on Muscle Energy Technique, Deep Breathing, Additional Natural Relxation Postures in addition Skin and Proprioceptive Awareness and Reciprocal Mussle .
Original Relaxation Exercises based on Skin and Proprioceptive Awareness and Reciprocal Mussle Inhibition
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.
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.
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.
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.
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.
Non-linear HRV Complexity Parameters (SD1/SD2 Ratio, Sample Entropy)
The SD1/SD2 ratio and sample entropy (SampEn), reflecting the complexity and unpredictability of heart rate dynamics, will be calculated from RR interval series. \[Unit: unitless\]
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.
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