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AI and Mindfulness Meditation for Stress Reduction in Medical Students

14 мая 2026 г. обновлено: Zabrina Kerr, Saint James School of Medicine

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

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

20

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Anguilla
      • The Quarter, Anguilla
        • Saint James School of Medicine

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Sequence AB
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.
Устройство: Apollo Neuro Wearable
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
Активный компаратор: Sequence BA
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.
Поведенческий: Mindfulness-Based Stress Reduction Course
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Perceived Stress Questionnaire
Временное ограничение: 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.
Baseline; Week 4 (end of Period 1); Week 9 (end of Period 2).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Heart Rate Variability
Временное ограничение: 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.
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).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Saint James School of Medicine

Следователи

  • Главный следователь: Mykhailo Vysochyn, MD, PhD, Saint James School of Medicine

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

15 мая 2024 г.

Первичное завершение (Действительный)

24 сентября 2024 г.

Завершение исследования (Действительный)

6 октября 2024 г.

Даты регистрации исследования

Первый отправленный

8 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

14 мая 2026 г.

Первый опубликованный (Действительный)

18 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • SaintJamesSoM

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Individual participant data will not be shared publicly due to the small sample size (n=20), sensitive physiological and psychological measures, lack of data-sharing infrastructure, and no requirement for public IPD sharing.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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