Stress and Anxiety
Conditions
Keywords
laura mitchell, relaxation exercises
Brief 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
Interventions
OTHERModified Mitchell Relaxation Exercises
Modified Relaxation Exercises based on Muscle Energy Technique, Deep Breathing, Additional Natural Relxation Postures in addition Skin and Proprioceptive Awareness and Reciprocal Mussle .
OTHERStandard Mitchell Relaxation Exercise
Original Relaxation Exercises based on Skin and Proprioceptive Awareness and Reciprocal Mussle Inhibition
Sponsors
Balikesir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Being 18-65 years old. * Having stress and anxiety
Exclusion criteria
* Taking cardioactive/psychotropic drugs. * Having a diagnosis of cardiovascular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RMSSD - Root Mean Square of Succesive Differences of RR Peaks of EKG | During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention. | Root Mean Square of Succesive Differences of RR Peaks of EKG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-Domain Heart Rate Variability Parameters (SDNN, RMSSD, Mean RR Interval) | 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 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. \[Unit: milliseconds\] |
| Absolute Spectral Power HRV Parameters (LF, HF) | During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention. | 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. \[Unit: ms²\] |
| LF/HF Ratio | During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention. | The ratio of low-frequency to high-frequency spectral power, reflecting sympathovagal balance, will be calculated from RR interval series. \[Unit: ratio (unitless)\] |
| Poincaré Plot HRV Parameters (SD1, SD2) | During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention. | 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. \[Unit: milliseconds\] |
| Non-linear HRV Complexity Parameters (SD1/SD2 Ratio, Sample Entropy) | During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention. | The SD1/SD2 ratio and sample entropy (SampEn), reflecting the complexity and unpredictability of heart rate dynamics, will be calculated from RR interval series. \[Unit: unitless\] |
Contacts
CONTACTUtku Berberoğlu, Assistant Professor
CONTACTDilek Işık, MsC
Outcome results
None listed