Stress, Psychological Clinical Trial
Official title:
The Effect of Daily Meditation on Stress, Mindfulness, Well-being, and Resilience in Student Pharmacists
NCT number | NCT05154565 |
Other study ID # | 21029 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2, 2021 |
Est. completion date | May 9, 2022 |
Verified date | May 2022 |
Source | Midwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | May 9, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Student pharmacists enrolled in the didactic curriculum in the Doctor of Pharmacy (PharmD) program during the Winter 2021/2022 quarter at the sponsoring institution Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Midwestern University College of Pharmacy | Downers Grove | Illinois |
Lead Sponsor | Collaborator |
---|---|
Midwestern University |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline in stress at 90 days | In the immediate intervention group (Group A) only, the change in perceived stress as measured by the Perceived Stress Scale four (4)-item measure (PSS-4; Cohen, Kamarck, & Mermelstein, 1983) from baseline will be examined at 90 days. The PSS-4 yields a total score from 0 to 16 with higher scores indicating more stress. | 90 days | |
Other | Change from baseline in mindfulness at 90 days | In the immediate intervention group (Group A) only, 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) from baseline will be examined at 90 days. 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. | 90 days | |
Other | Change from baseline in overall well-being at 90 days | In the immediate intervention group (Group A) only, 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 examined at 90 days. 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. | 90 days | |
Other | Change from baseline in resilience at 90 days | In the immediate intervention group (Group A) only, the change in resilience as measured by the six (6)-item Brief Resilience Scale (BRS; Smith, Dalen, Wiggins, et al., 2008) will be examined at 90 days. 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. | 90 days | |
Primary | Change from baseline in stress at 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. | 30 days | |
Primary | Change from baseline in mindfulness at 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. | 30 days | |
Primary | Change from baseline in overall well-being at 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. | 30 days | |
Primary | Change from baseline in resilience at 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. | 30 days | |
Secondary | Frequency of meditation app usage | During the respective intervention periods, de-identified usage data provided by the application maker will be examined to identify patterns of usage by study participants. For Group A (immediate group), students will self-report their usage in Phase 2 of the study. | 90 days | |
Secondary | Acceptability of the meditation app (participant questionnaire) | A questionnaire was developed for this study to measure participants' opinions of the acceptability of the meditation app used. This will be administered at the end of the respective intervention period for each group (Phase 1 for Group A and Phase 2 for Group B). The questionnaire includes items on the value meditation, ease of use, and ability to incorporate the intervention into their daily schedule. Higher scores indicate more positive responses. | 30 days | |
Secondary | Continued use of meditation (participant questionnaire) | A questionnaire was developed for this study to measure intended use of meditation in the future. Using the theory of planned behavior as a guiding theoretical framework, the questionnaire for future use included items on intentions to practice mindfulness or meditation in the next academic quarter, attitudes towards use of mindfulness or meditation practices, subjective norms surrounding engaging in mindfulness or meditation practices, and perceived behavioral control to engage in mindfulness or meditation practices. All items are scored such that higher scores represent more positive attitudes or opinions in each area.This questionnaire will be administered at the end of the each group's respective intervention period. Higher scores indicate more positive responses. | 30 days | |
Secondary | Experience with the meditation app (participant focus group) | Focus group sessions will be conducted to gather feedback from participants on their experiences using meditation. Qualitative analysis will be used to construct themes identified from the participant responses. | 120 days |
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