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

NCT04329533 | Completed

• 1 other identifier: 2003524869
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Perceived Stress; Anxiety; Sleep Disturbance

Keywords

COVID-19; mindfulness meditation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Hospital Anxiety and Depression Scale

  Completed study Day 0, study Day 14, and study Day 30

• PROMIS Sleep Disturbance Short Form Survey

  Completed study Day 0, study Day 14, and study Day 30

• Adherence

  From Day 0 to Day 30

• Participant Satisfaction

  Completed study Day 30

• Coronavirus Questionnaire

  Completed study Day 0 and study Day 30

Study Arms (2)

Intervention Group - access to meditation app

EXPERIMENTAL

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

Other: "Calm" is a mindfulness meditation mobile app

Control Group - no access to meditation app

NO INTERVENTION

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

Interventions

"Calm" is a mindfulness meditation mobile app 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.

Intervention Group - access to meditation app

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- No access to a smart phone

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medicine Women's Institute

Phoenix, Arizona, 85006, United States

Location

Related Publications (7)

• 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.

  PMID: 31237569 BACKGROUND

• 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.

  PMID: 31682582 BACKGROUND

• 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.

  PMID: 32039812 BACKGROUND

• 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.

  PMID: 30328241 BACKGROUND

• 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.

  PMID: 27116196 BACKGROUND

• 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.

  PMID: 31449907 BACKGROUND

• 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.

  PMID: 33957663 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Parasomnias; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Foley

  Director Department of Obstetrics and Gynecology BUMCP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 1, 2020
• Study Start: April 13, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)