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AI and Mindfulness Meditation for Stress Reduction in Medical Students

2026년 5월 14일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: 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
활성 비교기: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Perceived Stress Questionnaire
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
Heart Rate Variability
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Saint James School of Medicine

수사관

  • 수석 연구원: Mykhailo Vysochyn, MD, PhD, Saint James School of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 5월 15일

기본 완료 (실제)

2024년 9월 24일

연구 완료 (실제)

2024년 10월 6일

연구 등록 날짜

최초 제출

2026년 5월 8일

QC 기준을 충족하는 최초 제출

2026년 5월 14일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 14일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • SaintJamesSoM

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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