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

Study Overview

• Status: Not yet recruiting
• Conditions: Stress and Anxiety
• Intervention / Treatment: Other: Standard Mitchell Relaxation Exercise; Other: Modified Mitchell Relaxation Exercises

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Utku Berberoğlu, Assistant Professor; Phone Number: +905052017066; Email: utku.berberoglu@balikesir.edu.tr
• Study Contact Backup: Name: Dilek Işık, MsC; Phone Number: +905372569963; Email: caldilek10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Laura Mitchell Exercises	Other: Standard Mitchell Relaxation Exercise; 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
Experimental: Modified Mitchell Exercises	Other: Modified 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	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]	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)]	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]	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]	During a single intervention session (approximately 35 minutes), including 5 minutes before, throughout the 25-minute intervention, and 5 minutes after the intervention.

Collaborators and Investigators

• Sponsor: Balikesir University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: relaxation exercises; laura mitchell
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: GO 2026/125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Upon publication and indefinitely.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No