MedPath

Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic

Not Applicable
Conditions
PTSD
Perceived Stress
Sleep Disturbance
Anxiety
Burnout
Interventions
Device: Calm Meditation App
Registration Number
NCT04374786
Lead Sponsor
University of Arizona
Brief Summary

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.

Detailed Description

The COVID-19 global pandemic is significantly impacting healthcare providers and presumably affecting their stress level as they deal with this time of uncertainty. The COVID-19 public health crisis requires the full resources and attention of healthcare systems. This has led to several healthcare changes that affect physicians in training, including changes to rotations and schedules, risks of infection exposure to themselves or their families, and the unknown impacts this may have on their residency and fellowship experiences.

These changes are likely impacting their stress, health, and well-being. Physician burnout is major concern for the medical community and likely to be further impacted by the current pandemic. Evidence-based interventions for stress include cognitive behavior therapy, although this can be time consuming, requires the need for specialized providers, and is not feasible for everyone during this COVID-19 pandemic. Pharmacotherapy can be used, including antidepressants and anxiolytics, however they have inherent limitations such as side effects, tolerance, and interactions that limit their use. Consumer based mobile applications (apps) may help individuals with self-management strategies for stress. Mindfulness meditation is one type of self-management strategy and is the practice of moment-to-moment awareness in which the person purposefully focuses on the present without judgement.

"Calm" is a mobile app that offers a range of meditation lessons, sleep stories (bed-time stories for grown-ups), sleep music, and nature sounds with modules that vary in length, instruction, and content. Few studies on the use of "Calm" exist and include a randomized controlled trial evaluating its affect to decrease stress among college students and a descriptive study evaluating cancer patient's perceptions of the app. There is evidence to support the use of similar apps in resident physicians. A pilot study assessing the effects of a meditation app on resident wellness suggested both the feasibility and efficacy of such an intervention. During these unprecedented times of the COVID-19 pandemic, mobile apps such as Calm may be potentially beneficial to help with stress in house staff physicians, although this requires further investigation.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
328
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Intervention GroupCalm Meditation AppWill receive a 30-day are trial of the mobile meditation app "Calm" on study day 0
Primary Outcome Measures
NameTimeMethod
Perceived Stress ScaleCompleted study Day 30

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.

Secondary Outcome Measures
NameTimeMethod
Hospital Anxiety and Depression ScaleCompleted study Day 0, 14, and study Day 30

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.

Impact of Event Scale-6Completed study Day 0, 14, and study Day 30

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.

AdherenceFrom Day 0 to Day 30

Usage data from mobile app, minutes per day used

Coronavirus QuestionnaireCompleted study Day 0 and study Day 30

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.

PROMIS Sleep Disturbance Short Form SurveyCompleted study Day 0, 14, and study Day 30

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.

Participant SatisfactionCompleted study Day 30

Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length.

Maslach Burnout InventoryCompleted study Day 0, 14, and study Day 30

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.

Trial Locations

Locations (1)

Banner University Medical Center Phoenix

🇺🇸

Phoenix, Arizona, United States

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