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临床试验/NCT05154565
NCT05154565已完成不适用

The Effect of Daily Meditation on Stress, Mindfulness, Well-being, and Resilience in Student Pharmacists

Midwestern University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Change from baseline in overall well-being at 30 days

研究概览

简要总结

Pharmacy school is a 3-to-4 year intensive program that demands a high level of performance from enrolled students. The fast-paced and challenging curriculum causes stress levels to rise in students. The increase in stress can negatively affect performance in the classroom, as well as affect relationships outside the classroom setting. While some level of stress may be beneficial, the substantial amount of stress experienced by pharmacy students may also negatively impact their quality of life. This proposed study aims to explore the effect a convenient intervention on perceived stress, mindfulness, well-being, and resilience as reported by student pharmacists. Headspace will be used as the main study intervention. This product is a mobile device application (aka, an app) that teaches users how to meditate through guided exercises. It contains a library of different meditation exercises the user can access from their smartphone or tablet at their own convenience. It is our hope that the use of Headspace will enhance the students' ability to practice mindfulness, which will allow them to better cope with stress in school and in future practice. This could translate into improved learning and overall well-being.

详细描述

This research study aims to implement a mindfulness meditation routine delivered via the smartphone application Headspace to decrease perceived stress and improve well-being, resilience, and mindfulness in student pharmacists. This product is a mobile device application (aka, an app) that teaches users how to meditate through guided exercises. It contains a library of different meditation exercises the user can access from their smartphone or tablet at their own convenience. The use of a smartphone application will allow for convenience to promote adherence with the intervention among participants. The guided meditation sessions will teach participants how to live in the present moment and handle stressful situations that may arise in the future. As a result of this program the investigators expect to see an inverse relationship between mindfulness meditation and perceived stress and direct relationships between mindfulness meditation and well-being and resilience. By learning to incorporate mindfulness meditation into their lives, participating student pharmacists may be able to develop useful tools and effectively combat overwhelming situations they may face in the future.

This study will be conducted in two phases. Participating student pharmacists will be randomly assigned to one of two groups. In Phase 1, Group A will complete four (4) weeks of guided meditation while Group B does not use the application for meditation. Changes in study outcomes will be compared from baseline to the end of the initial intervention period. In Phase 2, Group B will be complete the guided meditation intervention. Group A will continue their usual daily habits. It is possible for some students from Group A may continue to use Headspace or another similar product to continue to incorporate meditation or mindfulness into their daily routine. At the end of Phase 2, the changes in study outcomes will be examined in Group B surrounding their use of the intervention. Outcomes will also be assessed in Group A at the end of Phase 2 to examine whether there are sustained changes in study outcomes and continued usage of meditation or mindfulness practices. All participating student pharmacists will also be invited to participate in one of several focus groups sessions to discuss experiences with the use of the guided meditation application.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Student pharmacists enrolled in the didactic curriculum in the Doctor of Pharmacy (PharmD) program during the Winter 2021/2022 quarter at the sponsoring institution

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in overall well-being at 30 days

时间窗: 30 days

The change in overall well-being as measured by the World Health Organization five (5)-item subjective well-being measure (WHO-5; World Health Organization, 1988) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). Scores are calculated by summing the responses for each item and then multiplying by four (4). The final score ranges from 0 to 100 with higher scores indicating better well-being.

Change from baseline in stress at 30 days

时间窗: 30 days

The change in perceived stress as measured by the Perceived Stress Scale four (4)-item measure (PSS-4; Cohen, Kamarck, \& Mermelstein, 1983) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). The PSS-4 yields a total score from 0 to 16 with higher scores indicating more stress.

Change from baseline in mindfulness at 30 days

时间窗: 30 days

The change in self-reported mindfulness as measured by the Five Facets of Mindfulness Questionnaire fifteen (15)-item measure (FFMQ-15; Baer, Smith, Lykins, et al., 2008) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). Based on recommendations by Gu, Strauss, Crane, et al (2016), only four factors will be analyzed for change: describing, acting with awareness, non-judging, non-reactivity. Scores are derived by taking the mean response from all items and separately for each domain. Mean scores range from 1 to 5 with higher scores indicating higher levels of mindfulness.

Change from baseline in resilience at 30 days

时间窗: 30 days

The change in resilience as measured by the six (6)-item Brief Resilience Scale (BRS; Smith, Dalen, Wiggins, et al., 2008) will be compared between groups. This will be compared using an intent to treat approach and a per protocol approach (defined as those who were at least 80% adherent to the use of the mindfulness app). Scores are calculated by summing the responses for each item and then dividing by six (6) to yield an overall mean score. The overall mean score ranges from 1 to 5 with higher scores indicating greater resilience.

次要结局

  • Acceptability of the meditation app (participant questionnaire)(30 days)
  • Continued use of meditation (participant questionnaire)(30 days)
  • Frequency of meditation app usage(90 days)
  • Experience with the meditation app (participant focus group)(120 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Spencer Harpe

Professor of Pharmacy

Midwestern University

研究点 (2)

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