Effects of Using Mobile App on Perceived Stress During COVID-19 Pandemic

NCT ID: NCT04329533

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2020-11-01

Brief 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.

Conditions

Perceived Stress; Anxiety; Sleep Disturbance

Keywords

COVID-19; mindfulness meditation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group - access to meditation app

Will receive a 30-day free trial of the mobile meditation app "Calm" on study day 0

Group Type: EXPERIMENTAL

"Calm" is a mindfulness meditation mobile app

Intervention Type: OTHER

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.

Control Group - no access to meditation app

Will not have the intervention until after the 30 day study period and then will receive a 30-day free trial of the mobile meditation app "Calm" on study day 30

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Rachael Bailey Smith

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mike Foley

Role: STUDY_DIRECTOR

Director Department of Obstetrics and Gynecology BUMCP

Locations

Banner University Medicine Women's Institute

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31237569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31682582 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32039812 (View on PubMed)

Nery SF, Paiva SPC, Vieira EL, Barbosa AB, Sant'Anna EM, Casalechi M, Dela Cruz C, Teixeira AL, Reis FM. Mindfulness-based program for stress reduction in infertile women: Randomized controlled trial. Stress Health. 2019 Feb;35(1):49-58. doi: 10.1002/smi.2839. Epub 2018 Oct 16.

Reference Type: BACKGROUND

PMID: 30328241 (View on PubMed)

Kanter G, Komesu YM, Qaedan F, Jeppson PC, Dunivan GC, Cichowski SB, Rogers RG. Mindfulness-based stress reduction as a novel treatment for interstitial cystitis/bladder pain syndrome: a randomized controlled trial. Int Urogynecol J. 2016 Nov;27(11):1705-1711. doi: 10.1007/s00192-016-3022-8. Epub 2016 Apr 26.

Reference Type: BACKGROUND

PMID: 27116196 (View on PubMed)

Weston E, Raker C, Huang D, Parker A, Robison K, Mathews C. The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1119-1126.e2. doi: 10.1016/j.jmig.2019.08.021. Epub 2019 Aug 23.

Reference Type: BACKGROUND

PMID: 31449907 (View on PubMed)

Smith RB, Mahnert ND, Foote J, Saunders KT, Mourad J, Huberty J. Mindfulness Effects in Obstetric and Gynecology Patients During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):1032-1040. doi: 10.1097/AOG.0000000000004316.

Reference Type: DERIVED

PMID: 33957663 (View on PubMed)

Other Identifiers

2003524869

Identifier Type: -

Identifier Source: org_study_id