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.
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.
Other: "Calm" is a mindfulness meditation mobile app
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.
Inclusion Criteria:
- Female sex
- Greater than or equal to 18 years old
- English-speaking
- Established obstetrics/gynecology (OB/Gyn) patients of Banner University Medical
Center - Phoenix (BUMCP)
- OB patients must be less than or equal to 34 weeks gestational age
- Gyn patients must have had a scheduled gynecologic surgery that was delayed or
canceled for at least 30 days from the time of study enrollment due to the COVID-19
restrictions
Exclusion Criteria:
- No access to a smart phone
Banner University Medicine Women's Institute
Phoenix, Arizona, United States
Mike Foley, Study Director
Director Department of Obstetrics and Gynecology BUMCP