AI and Mindfulness Meditation for Stress Reduction in Medical Students

NCT07591935 | Completed

• 1 other identifier: SaintJamesSoM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if two stress-reduction methods can lower stress in medical students. The study compares a wearable device and a mindfulness program. The wearable device sends gentle vibrations to the body, while the mindfulness program teaches meditation and stress awareness skills. The main questions it aims to answer are:

• Does the wearable device lower stress levels in medical students?
• Does mindfulness meditation lower stress levels in medical students?
• Is one method more effective than the other? Researchers will compare the wearable device to the mindfulness program to see if one works better for reducing stress. Participants are medical students from Saint James School of Medicine. Each participant will try both methods during the study. Participants will:
• Use the wearable device daily for four weeks
• Complete a four-week mindfulness meditation program
• Take a one-week break between the two methods
• Complete surveys about stress and satisfaction
• Have heart rate variability (HRV) measured to assess stress levels This study will help researchers understand whether wearable technology or mindfulness training is more effective for managing stress in medical students. It may also show if both methods can improve how the body responds to stress over time.

Conditions

Stress

Keywords

Vagus Nerve; Apollo Neuro; Heart Rate Variability; Perceived Stress Questionnaire; Mindfulness-Based Stress Reduction; Medical Students; Stress; AI wearable device; Hypothalamus-pituitary axis

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Questionnaire

  The primary outcome is change in perceived stress among medical students, measured using a validated self-report linear Likert scale such as the Perceived Stress Questionnaire. This measure assesses the degree to which participants perceive their life situations as stressful, including feelings of overload, unpredictability, and lack of control. PSQ scores will be compared within participants in a randomized two-period crossover design evaluating the effects of a 4-week Mindfulness-Based Stress Reduction (MBSR) program and a 4-week Apollo Neuro device intervention.

  Baseline; Week 4 (end of Period 1); Week 9 (end of Period 2).

Secondary Outcomes (1)

• Heart Rate Variability

  During each intervention period (approximately 4 weeks per period), with comparison of HRV outcomes between Period 1 and Period 2 following completion of each phase of the crossover design (approximately 8 weeks total after enrolment).

Study Arms (2)

Sequence AB

EXPERIMENTAL

Participants assigned to Sequence AB receive Treatment A in Period 1 followed by Treatment B in Period 2, with a washout period between treatments. Treatment A consists of an AI-supported mindfulness-based stress reduction (MBSR-style) intervention delivered over the first study period. Treatment B consists of a control or alternative stress-reduction condition delivered over the second study period. Outcomes are assessed at baseline and at the end of each period to evaluate within-subject changes in stress and wellbeing.

Device: Apollo Neuro Wearable

Sequence BA

ACTIVE COMPARATOR

Participants assigned to Sequence BA receive Treatment B in Period 1 followed by Treatment A in Period 2, with a washout period between treatments. Treatment B consists of a control or alternative stress-reduction condition delivered during the first study period. Treatment A consists of an AI-supported mindfulness-based stress reduction (MBSR-style) intervention delivered during the second study period. Outcomes are assessed at baseline and at the end of each period to evaluate within-subject differences in stress and wellbeing.

Behavioral: Mindfulness-Based Stress Reduction Course

Interventions

Mindfulness-Based Stress Reduction Course BEHAVIORAL

The MBSR intervention is an evidence-based structured mindfulness program designed to reduce stress and improve psychological wellbeing. Participants engage in guided mindfulness practices including focused attention meditation, body scanning, and breathing exercises. The intervention emphasizes present-moment awareness and non-judgmental observation of thoughts and emotions. Sessions are delivered over a defined study period and are complemented by brief daily at-home mindfulness practice. The goal is to reduce perceived stress, in medical students through repeated mindfulness training and cognitive regulation strategies.

Sequence BA

Apollo Neuro Wearable DEVICE

The Apollo Neuro intervention involves the use of a wearable neuromodulation device designed to support stress regulation through gentle, non-invasive vibration patterns. The device delivers low-frequency tactile stimulation intended to promote parasympathetic nervous system activation and improve autonomic balance. Participants wear the device during designated periods throughout the day (e.g., study, relaxation, or sleep) according to a standardized protocol. The intervention aims to reduce physiological and perceived stress levels through continuous somatic signaling and nervous system modulation

Sequence AB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical Student at Saint James Medical School
• Proficient in English

You may not qualify if:

• Insufficient stress levels
• Already owning an Apollo Device
• Inability to provide informed consent
• Have any medical condition that precluded the use of Apollo

Sponsors & Collaborators

• Saint James School of Medicine: lead

Study Sites (1)

Saint James School of Medicine

The Quarter, Anguilla

Location

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Study Officials

• Mykhailo Vysochyn, MD, PhD

  Saint James School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 18, 2026
• Study Start: May 15, 2024
• Primary Completion: September 24, 2024
• Study Completion: October 6, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)