AI and Mindfulness Meditation for Stress Reduction in Medical Students
2026年5月14日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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The Quarter、Anguilla
- Saint James School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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
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アクティブコンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perceived Stress Questionnaire
時間枠：Baseline; Week 4 (end of Period 1); Week 9 (end of Period 2).
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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.
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Baseline; Week 4 (end of Period 1); Week 9 (end of Period 2).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Heart Rate Variability
時間枠：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).
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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.
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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).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Mykhailo Vysochyn, MD, PhD、Saint James School of Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年5月15日
一次修了 (実際)
2024年9月24日
研究の完了 (実際)
2024年10月6日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月14日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年5月14日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- SaintJamesSoM
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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