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NCT Number: NCT07713407

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

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

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Key information

Conditions

Stress and Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being 18-65 years old.
  • Having stress and anxiety

Exclusion criteria

  • Taking cardioactive/psychotropic drugs.
  • Having a diagnosis of cardiovascular disease.

Treatment and study plan

Modified Mitchell Relaxation Exercises

Other

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

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

Other names: Simple Relaxation, Physiologic Relaxation Technique, Simple Relaxation Technique, Simple Relaxation Exercise

Primary outcomes

  1. RMSSD - 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.

    Root Mean Square of Succesive Differences of RR Peaks of EKG

Secondary outcomes

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

    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 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]

  2. Absolute Spectral Power HRV Parameters (LF, HF)

    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.

    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]

  3. LF/HF Ratio

    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.

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

  4. Poincaré Plot HRV Parameters (SD1, SD2)

    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.

    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]

  5. Non-linear HRV Complexity Parameters (SD1/SD2 Ratio, Sample Entropy)

    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.

    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]

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek Işık, MsC

CONTACT

[email protected]

+905372569963

Utku Berberoğlu, Assistant Professor

CONTACT

[email protected]

+905052017066

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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