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Идёт набор NCT07127575

Scalable Intervention for Stress Management

Без фазы С лечением Stress Diaphragmatic Breathing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Resistance Breathing Device, Electronic Resistance Breathing Device.
Кому может быть актуально
Состояния в реестре: Stress, Diaphragmatic Breathing. Базовые параметры: 18 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Scalable Intervention for Stress Management Practices

Обзор

The purpose of this research is to measure the acceptance of a resistance breathing intervention and to assess whether it produces physiological and subjective effects in a laboratory setting.

Подробное описание

College students experience a wide range of stressors during their studies, with many students experiencing levels of stress that can be clinically significant, such as anxiety or depression. Counseling centers on college campuses have seen a rise in students seeking mental health support or stress relief, but there exists a discrepancy in the level of need versus the support that can be provided. Stress management interventions, such as self-care mobile applications and devices, have risen in popularity given their relative accessibility and implementation of stress relieving interventions such as regulated breathing. Regulated breathing has been shown to be a reliable and effective form of stress relief, however its implementation within various eHealth interventions and related devices can come into conflict when used in educational settings. Mobile apps and biofeedback devices (e.g., chest straps, inhalers), can be contextually inappropriate, cumbersome, and potentially stigmatizing for students. To overcome these barriers, the PI developed the AIRpen, a simple, affordable, multi-functional stress management device that is designed to fit into the fabric of students' lives to potentially optimize the delivery, practice, and fidelity of diaphragmatic breathing (DB) interventions in real- world settings. With anecdotal and empirical evidence supporting the device as feasible and acceptable in real-world academic settings, this study will build upon prior work and measure the acceptance of the intervention and assess whether using the original and a "smart" version of the device as a stress relieving tool produces physiological and subjective effects in a laboratory setting.

Вмешательства

  • Устройство Resistance Breathing Device
    The AIRpen is a multifunctional stress management tool that helps users engage in diaphragmatic breathing at differing resistance levels, as well as other common stress relieving behaviors such as fidgeting
  • Устройство Electronic Resistance Breathing Device
    The Smart AIRpen functions just as the original AIRpen device and has been augmented with sensors to measure use patterns to determine whether the AIRpen is being used for fidgeting or breathing.

Первичные конечные точки

  • Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM) [Срок оценки: From enrollment to end of 1 hour study period.]
  • Device Usability as Measured by a Modified Version of the System Usability Scale (SUS) [Срок оценки: From enrollment until completion of 1 hour study period.]
Вторичные конечные точки (2)
  • Perceived Stress as Measured by the Perceived Stress Scale (PSS_10) [Срок оценки: From enrollment to the end of the 1 hour study period]
  • Physiological Stress as Assessed with Heart Rate Monitoring [Срок оценки: From study enrollment to end of 1 hour study period]

Критерии участия

Критерии включения

  • Be at least 18 years old
  • Be currently enrolled in a college or university
  • Be able to read, speak, and comprehend English
  • Be able and willing to complete a 60-minute study involving heart rate monitoring, survey completion, training, a stress test, and device utilization

Критерии исключения

-Individuals diagnosed with anxiety or stress and require professional support to cope with these clinical levels of stress or anxiety should not enroll in the study in place of professional assistance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Purdue University — West Lafayette

Идентификаторы

NCT: NCT07127575 · IRB-2025-935 · 1R41AT012854-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗