Stress and AnxietyNCT07713407
The Effect of the Modified Mitchell Relaxation Method on Acute Cardiac Autonomic Modulation
A study testing Modified Mitchell Relaxation Exercises and Standard Mitchell Relaxation Exercise in people with Stress and Anxiety, run by Balikesir University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress and Anxiety
- What is being tested?
- Modified Mitchell Relaxation Exercises and Standard Mitchell Relaxation Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18-65 years old.
- Having stress and anxiety
Who cannot join
- Taking cardioactive/psychotropic drugs.
- Having a diagnosis of cardiovascular disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Stress and Anxiety
- Being tested
- Modified Mitchell Relaxation Exercises, Standard Mitchell Relaxation Exercise
- Keywords
- laura mitchell, relaxation exercises
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Mitchell Relaxation ExercisesOther
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 ExerciseOther
Also called Simple Relaxation, Physiologic Relaxation Technique, Simple Relaxation Technique, Simple Relaxation Exercise
Original Relaxation Exercises based on Skin and Proprioceptive Awareness and Reciprocal Mussle Inhibition
| Study group | Role | What they receive |
|---|---|---|
| Standard Laura Mitchell Exercises | Experimental | Not described Receives: Other: Standard Mitchell Relaxation Exercise |
| Modified Mitchell Exercises | Experimental | Not described Receives: Other: Modified Mitchell Relaxation Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMSSD - Root Mean Square of Succesive Differences of RR Peaks of EKG
Root Mean Square of Succesive Differences of RR Peaks of EKG
Measured: 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 (5)
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]
Measured: 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]
Measured: 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)]
Measured: 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]
Measured: 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]
Measured: During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress and AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utku Berberoğlu, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713407
- Sponsor's protocol ID
- GO 2026/125
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data collected during the trial will be made available indefinitely in a publicly accessible data repository immediately following the publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Modified Mitchell Relaxation Method on Acute Cardiac Autonomic Modulation
- ClinicalTrials.gov ID
- NCT07713407
- Acronym / sponsor ID
- GO 2026/125
- Conditions
- Stress and Anxiety
- Keywords
- laura mitchell, relaxation exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Laura Mitchell Exercises | Experimental | Other: Standard Mitchell Relaxation Exercise |
| Modified Mitchell Exercises | Experimental | Other: Modified Mitchell Relaxation Exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being 18-65 years old.
- Having stress and anxiety
Key exclusion criteria (2 listed)
- Taking cardioactive/psychotropic drugs.
- Having a diagnosis of cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Mitchell Relaxation ExercisesModified Relaxation Exercises based on Muscle Energy Technique, Deep Breathing, Additional Natural Relxation Postures in addition Skin and Proprioceptive Awareness and Reciprocal Mussle . | Other | Modified Mitchell Exercises |
| Standard Mitchell Relaxation ExerciseAlso: Simple Relaxation, Physiologic Relaxation Technique, Simple Relaxation Technique, Simple Relaxation ExerciseOriginal Relaxation Exercises based on Skin and Proprioceptive Awareness and Reciprocal Mussle Inhibition | Other | Standard Laura Mitchell Exercises |
Primary outcome
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
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data collected during the trial will be made available indefinitely in a publicly accessible data repository immediately following the publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Mitchell Relaxation Exercises and Standard Mitchell Relaxation Exercise in people with Stress and Anxiety, run by Balikesir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Utku Berberoğlu, Assistant Professor (+905052017066, utku.berberoglu@balikesir.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.