Effects of Using Mobile App on Perceived Stress During COVID-19 Pandemic
Condition: Perceived Stress; Anxiety; Sleep Disturbance
MeSH terms: COVID-19; Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Due to the COVID-19 global health pandemic, many people are likely experiencing increased
      stress. Many obstetrics and gynecology patients are additionally experiencing increased
      stress due to the healthcare changes the COVID-19 pandemic has caused including delayed or
      canceled elective surgeries, visitor restrictions, and telemedicine visits instead of in
      person clinic visits. Mindfulness meditation is a self-management strategy that can be
      utilized by anyone to assist with the management of stress. Mindfulness 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 randomized controlled trial
      evaluating perceived stress, anxiety, and sleep disturbance in the investigators outpatient
      OB/Gyn patients at Banner Women's Institute, with the use of a 30 day trial of the
      mindfulness meditation app, "Calm." All patients would ultimately receive a 30 day free trial
      of the mobile meditation app, however the intervention group would receive the 30-day free
      trial immediately and the control group would receive the 30-day free trial after the study
      period which is 30 days after enrollment. The investigators additionally want to evaluate the
      feasibility of using the mobile app, including looking at adherence to use of the app and
      patient satisfaction with use of the app.
    

Detailed description: 
      The COVID-19 global pandemic is at the top of many people's minds and is presumably effecting
      the stress level of most Americans during 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 obstetrics and gynecology patients, including
      delays and cancellations in elective surgery, visitor restrictions, and transitioning from in
      person outpatient visits to telemedicine visits. The American College of Obstetricians and
      Gynecologists (ACOG) joined with several other OB/Gyn societies to announce their joint
      statement on March 16th, 2020 to reduce the number of elective surgeries in OB/Gyn to free up
      healthcare resources. Hospitals and outpatient clinics are instituting visitor restrictions.
      Specifically, at Banner University Medical Center - Phoenix (BUMCP), they are not allowing
      any visitors with the exception of one visitor for an obstetric laboring patient or for
      pediatric patients. All "non-essential" OB and Gyn visits are transitioning to telemedicine
      visits through the telephone or video conferencing platforms, with the exception of obstetric
      visits that require labs, vitals, or fetal assessments.

      These healthcare changes to OB/Gyn patients is likely impacting their level of stress.
      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 all
      patients 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 (1). 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 (1,2).

      "Calm" is a mindfulness meditation mobile app that offers a range of mindfulness meditation
      practice guide modules that vary in length, instruction, and content. The app includes
      meditation lessons, sleep stories (bed-time stories for grown-ups), sleep music, and nature
      sounds. 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 (1,3). There is limited literature on the
      effects of mindfulness meditation in obstetrics and gynecology and include its effects on
      postoperative pain, infertility, and painful bladder (4-6). During these unprecedented times
      of the COVID-19 pandemic, mindfulness meditation mobile apps such as Calm may be potentially
      beneficial to help with stress in OB/Gyn patients, although this requires further
      investigation.

      The purpose of this study is to compare the effects of the mindfulness meditation app "Calm"
      on stress, anxiety, and sleep in outpatient obstetrics and gynecology patients during the
      COVID-19 pandemic. Participants will be randomized to two groups; Arm 1 receives a 30 day
      free trial at the start of the study, Arm 2 receives a 30 day free trial at the conclusion of
      the study. All participants will complete a baseline survey on perceived stress, anxiety, and
      sleep at the start of the study, again at 2 weeks into the study, and again one month later.

      The investigator's primary objective is to evaluate perceived stress (validated Perceived
      Stress Scale) with use of the mindfulness meditation app, "Calm," among outpatient OB/Gyn
      patients during COVID-19 pandemic. The investigator's secondary objectives are to evaluate
      anxiety (validated Hospital Anxiety and Depression Scale) and sleep (validated PROMIS Sleep
      Disturbance Short Form) with use of the mindfulness meditation app, "Calm," among outpatient
      OB/Gyn patients during COVID-19 pandemic. Additionally, the investigators want to assess
      feasibility with using the app which includes measurements of adherence and participant
      satisfaction with use of the app.
    

Intervention name(s): "Calm" is a mindfulness meditation mobile app
Intervention type(s): Other
Intervention description(s): Mindfulness meditation is a self-management strategy that can be utilized to assist with the management of stress. Mindfulness meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms including Arm 1 who receives a 30 day free trial of the app at the start of the study and Arm 2 who receives a 30 day free trial at the conclusion of the study. All participants will complete a baseline survey on perceived stress, anxiety, and sleep, a survey on stress at 2 weeks, and all three surveys again one month later.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COVID-19; mindfulness meditation