- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04329533
Effects of Using Mobile App on Perceived Stress During COVID-19 Pandemic
Effects of a Mobile Meditation App on Stress During COVID-19 Pandemic in Outpatient Obstetrics and Gynecology Patients; a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
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Phoenix, Arizona, United States, 85006
- Banner University Medicine Women's Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group - access to meditation app
Will receive a 30-day free trial of the mobile meditation app "Calm" on study day 0
|
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.
|
No Intervention: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: Completed study Day 0
|
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
Time Frame: Completed study Day 14
|
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
Time Frame: Completed 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.
|
Completed study Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale
Time Frame: Completed study Day 0, study Day 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.
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Completed study Day 0, study Day 14, and study Day 30
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PROMIS Sleep Disturbance Short Form Survey
Time Frame: Completed study Day 0, study Day 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.
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Completed study Day 0, study Day 14, and study Day 30
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Adherence
Time Frame: From Day 0 to Day 30
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Usage data from mobile app, minutes per day used, days per week used
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From Day 0 to Day 30
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Participant Satisfaction
Time Frame: Completed study Day 30
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Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length and measured with 5-point Likert scale.
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Completed study Day 30
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Coronavirus Questionnaire
Time Frame: Completed 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.
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Completed study Day 0 and study Day 30
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mike Foley, Director Department of Obstetrics and Gynecology BUMCP
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Sleep Wake Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Dyssomnias
- Parasomnias
Other Study ID Numbers
- 2003524869
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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