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

NCT07713407 | Not Yet Recruiting

• 1 other identifier: GO 2026/125
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stress and Anxiety

Keywords

laura mitchell; relaxation exercises

Outcome Measures

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

  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)

  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)

  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

  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)

  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)

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

Study Arms (2)

Standard Laura Mitchell Exercises

EXPERIMENTAL

Other: Standard Mitchell Relaxation Exercise

Modified Mitchell Exercises

EXPERIMENTAL

Other: Modified Mitchell Relaxation Exercises

Interventions

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 .

Modified Mitchell Exercises

Standard Mitchell Relaxation Exercise OTHER

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

Also known as: Simple Relaxation, Physiologic Relaxation Technique, Simple Relaxation Technique, Simple Relaxation Exercise

Standard Laura Mitchell Exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Balikesir University: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Utku Berberoğlu, Assistant Professor

CONTACT

+905052017066; utku.berberoglu@balikesir.edu.tr

Dilek Işık, MsC

CONTACT

+905372569963; caldilek10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication and indefinitely.
• Access Criteria: Data will be made publicly available in an open-access repository immediately after publication. There are no restrictions on access, and no formal application or approval is required to download the de-identified dataset.