A Scalable Intervention for Stress Management Real World Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Device Usability as Measured by a Modified Version of the System Usability Scale (SUS)
研究概览
简要总结
The purpose of this study is to examine the usability and effectiveness of a stress management device during an academic exam period and asks the following questions:
- To what extent is a resistance breathing device (AIRpen) utilized by participants during the study period?
- What impact does utilizing a resistance breathing device have on participant's well-being when used during a stressful academic period?
- To what extent is a diaphragmatic breathing device acceptable for use when utilized during a noted stress-inducing period such as academic examinations?
详细描述
This study aims to build upon prior work with a diaphragmatic breathing intervention, testing the acceptability and usability of a resistance breathing device for stress reduction (i.e., the AIRpen) amongst college students during the academic semester. Regulated breathing has been shown to be an accessible and effective form of stress reduction, with prior research identifying diaphragmatic breathing as a key form of stress reduction that can impart cognitive, emotional, and physical benefits. Accomplishing diaphragmatic breathing can be difficult however, as it is a skill which requires considerable practice and can be challenging to perform properly without assistance.
To address this, a number of eHealth and physical applications (e..g, inhalers, mediations apps, chest straps) have arisen which seek to assist individuals in regulating their breathing and facilitating diaphragmatic breathing. However, the suitability of such interventions varies greatly, and may not always be appropriate for different contexts. For college students especially, a group which experiences a wide range of stressors within the course of their studies, interventions such as eHealth mobile applications or inhalers may be cumbersome, contextually inappropriate, or potentially stigmatizing when utilized within their educational environment. To address this, the PI has developed the AIRpen, a simple, affordable, and multi-functional stress management and regulated breathing device which aims to blend into a student's environment and assist in achieving diaphragmatic breathing in a discreet and effective manner. With anecdotal and empirical evidence supporting the device as feasible and acceptable in real-world academic settings (Purdue IRB-2022-423), this study will build upon prior work and measure the acceptability and feasibility of the AIRpen, as well as it's effect on perceived stress and coping self-efficacy amongst college students. As the purpose of this study, which is being funded by the NIH, is to study use of the AIRpen amongst college aged individuals, college students are not a convenience sample but actually the target sample for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 2-week long study involving survey completion, training, and AIRpen utilization during an academic examination period
排除标准
- •- Individuals with a diagnosis of anxiety or stress that require professional support to cope with such clinical levels of stress or anxiety should not enroll in the study in place of professional assistance
研究组 & 干预措施
Undergraduate Exam Takers
College undergraduate students between the ages of 18-30 who will be involved in an academic examination period at Purdue University.
结局指标
主要结局
Device Usability as Measured by a Modified Version of the System Usability Scale (SUS)
时间窗: From study enrollment to the end of the study at 2 weeks.
The System Usability Scale is a 10-item measure that address the usability and learnability of a system. The SUS has been modified to reflect the AIRpen intervention. Statements are ranked on a Likert scale for 1-5, with 1 indicating "Strongly Disagree" and 5 indicating "Strongly Agree". Raw scores are converted into a final score that ranges from 0-100, with a larger score indicating greater usability.
Device Acceptability as Measured by the Acceptability of Intervention Measure (AIM)
时间窗: From study enrollment to the end of the study at 2 weeks.
The AIM measure is designed to assess the acceptability of a intervention, and has been adapted in relation to the AIRpen. Participants rate statements related to their usage and experience of the AIRpen and AIRpen website, with ratings ranging from "Completely Disagree" (1), to "Completely Agree" (5). Higher scores indicate higher acceptability of the intervention.
Device Feasibility as Measured by the Feasibility of Intervention Measure (FIM)
时间窗: From study enrollment until the end of the study at 2 weeks.
The Feasibility of Intervention Measure (FIM) measures the feasibility of an intervention through a 5-point Likert scale, and has been adapted in relation to the AIRpen. Statements relate to the overall feasibility of the intervention, with 1 indicating "Completely disagree" while 5 indicates (Completely agree), with a higher score indicating greater feasibility.
次要结局
- Problem-Focused Coping as Measured by the Coping Self-Efficacy Scale (CSES)(From study enrollment to the end of the study at 2 weeks)
- Perceived Stress as Measured by the Perceived Stress Scale (PSS_10)(From study enrollment to the end of the study at 2 weeks.)