Skip to main content
OpenTrials
Completed

NCT Number: NCT07591935

AI and Mindfulness Meditation for Stress Reduction in Medical Students

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint James School of Medicine

The Quarter, Anguilla

About this study

This study is a randomized, unblinded, two-period crossover clinical trial designed to evaluate and compare the effects of a wearable stress-modulation device and a mindfulness-based stress reduction (MBSR) program on stress levels in medical students.

Stress is common among medical students due to academic demands and challenges with maintaining work-life balance. Chronic stress can negatively affect both mental and physical health, including cognitive performance and emotional well-being. Interventions that improve stress regulation may help support student health and academic success.

This study investigates two non-invasive approaches to stress reduction: a wearable device that delivers gentle vibratory stimulation intended to regulate the autonomic nervous system, and a structured mindfulness meditation program designed to improve stress awareness and emotional regulation.

A total of 20 medical students from Saint James School of Medicine were enrolled and randomly assigned in a 1:1 ratio to one of two sequences:

  • Sequence AB: mindfulness-based stress reduction (MBSR) followed by the wearable device
  • Sequence BA: wearable device followed by MBSR

Each intervention period lasted four weeks and was separated by a one-week washout period to reduce potential carryover effects.

Participants in the MBSR group completed a structured mindfulness program focused on meditation practices and stress management techniques. Participants in the wearable device group used the device regularly during daily activities.

Outcome measures included both subjective and objective assessments:

  • Heart rate variability (HRV), used as a physiological marker of autonomic nervous system regulation and stress response
  • Patient Satisfaction Questionnaire (PSQ), using a five-point Likert scale
  • Qualitative surveys to assess participant experiences and perceived stress

The primary objective was to determine whether the wearable device is more effective than mindfulness meditation in reducing stress, as measured by HRV and self-reported outcomes.

Results showed no statistically significant difference between the two interventions in terms of HRV or patient-reported satisfaction. However, both interventions were associated with improvements in HRV over time, suggesting enhanced autonomic regulation. Mindfulness-based stress reduction demonstrated a stronger initial effect, while the wearable device showed smaller but consistent improvements. No significant carryover effects were observed between intervention periods.

These findings suggest that both interventions may support stress reduction and improved autonomic nervous system function in medical students. The wearable device offers a practical advantage, as it can be used during daily activities without requiring dedicated time for practice, unlike mindfulness training.

Future research should include larger sample sizes, consider cultural and environmental factors influencing stress, and use blinded study designs to reduce bias.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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

Primary outcomes

  1. Perceived Stress Questionnaire

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

    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.

Secondary outcomes

  1. Heart Rate Variability

    Time frame: 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).

    Heart rate variability (HRV) is a secondary physiological outcome used to assess autonomic nervous system regulation and stress response. HRV reflects the variation in time intervals between consecutive heartbeats and serves as an objective marker of parasympathetic (vagal) activity and stress resilience. In this randomized two-period, two-sequence (AB/BA) crossover study, each participant serves as their own control, allowing within-subject comparison of HRV across intervention conditions. HRV measurements are used to evaluate changes in physiological stress regulation in response to each intervention period.

Sponsors and collaborators

Lead sponsor

Saint James School of Medicine

Other

Registry information

Official study title

Artificial Intelligence and Mindfulness Meditation: Innovative Methods to Reduce Stress Amongst Medical School Students

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 18, 2026
Registry last updated
May 18, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.