Anxiety Clinical Trial
Official title:
Effects of a Mobile App on Health and Well-being During COVID-19 Pandemic in House Staff at Banner University Medical Center Phoenix
Verified date | June 2020 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.
Status | Enrolling by invitation |
Enrollment | 328 |
Est. completion date | October 1, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - All resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006. Exclusion Criteria: - Non-resident and fellow physicians at Banner University Medical Center Phoenix, 1111 E. McDowell Rd, Phoenix, AZ 85006. |
Country | Name | City | State |
---|---|---|---|
United States | Banner University Medical Center Phoenix | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273. — View Citation
Huberty J, Puzia M, Eckert R, Larkey L. Cancer Patients' and Survivors' Perceptions of the Calm App: Cross-Sectional Descriptive Study. JMIR Cancer. 2020 Jan 25;6(1):e16926. doi: 10.2196/16926. — View Citation
Huberty J, Vranceanu AM, Carney C, Breus M, Gordon M, Puzia ME. Characteristics and Usage Patterns Among 12,151 Paid Subscribers of the Calm Meditation App: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2019 Nov 3;7(11):e15648. doi: 10.2196/15648. — View Citation
Wen L, Sweeney TE, Welton L, Trockel M, Katznelson L. Encouraging Mindfulness in Medical House Staff via Smartphone App: A Pilot Study. Acad Psychiatry. 2017 Oct;41(5):646-650. doi: 10.1007/s40596-017-0768-3. Epub 2017 Aug 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived Stress Scale | Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress. | Completed study Day 0 | |
Primary | Perceived Stress Scale | Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress. | Completed study Day 14 | |
Primary | Perceived Stress Scale | Validated perceived stress scale survey, 10 questions in length rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress. | Completed study Day 30 | |
Secondary | Hospital Anxiety and Depression Scale | Validated anxiety and depression scale survey, 14 questions in length rated on a 4-point Likert scale. Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating probable presence of the mood disorder. | Completed study Day 0, 14, and study Day 30 | |
Secondary | PROMIS Sleep Disturbance Short Form Survey | Patient Reported Outcomes Measurement Information System (PROMIS) is a validated sleep disturbance short form survey, 8 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (very much). Possible scores range from 0 to 21 for anxiety and 0 to 21 for depression with higher scores indicating greater severity of sleep disturbance. | Completed study Day 0, 14, and study Day 30 | |
Secondary | Impact of Event Scale-6 | The Impact of Event Scale-6 is a validated post traumatic event survey, 6 questions in length rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The score ranges from a minimum of 6 to a maximum of 30 with higher scores indicating higher traumatic stress. | Completed study Day 0, 14, and study Day 30 | |
Secondary | Maslach Burnout Inventory | The Maslach Burnout Inventory is a validated burnout survey, 22 questions in length with 3 sub scales including emotional exhaustion, depersonalization, and personal accomplishment. Each question is rated on a 7 point Likert scale ranging from 0 (never) to 6 (every day). The score for each sub scales range from minimum 0 to maximum 18. High scores of emotional exhaustion and depersonalization sub scales and a lower score of personal accomplishment indicates a higher level of burnout. | Completed study Day 0, 14, and study Day 30 | |
Secondary | Adherence | Usage data from mobile app, minutes per day used | From Day 0 to Day 30 | |
Secondary | Coronavirus Questionnaire | Investigator developed questionnaire about perceptions on coronavirus completed on Day 0 and Day 30, 10 questions in length and measured with 5-point Likert scale. 1= very low, 2=low, 3=moderate, 4=high, 5= very high. | Completed study Day 0 and study Day 30 | |
Secondary | Participant Satisfaction | Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length. | Completed study Day 30 |
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