Perceived StressNCT04329533
Effects of Using Mobile App on Perceived Stress During COVID-19 Pandemic
A study testing "Calm" is a mindfulness meditation mobile app in people with Perceived Stress and Anxiety, run by University of Arizona at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perceived Stress, Anxiety, Sleep Disturbance
- What is being tested?
- "Calm" is a mindfulness meditation mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2020to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No access to a smart phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medicine Women's Institute
Phoenix, Arizona, 85006
About this study
Official title: Effects of a Mobile Meditation App on Stress During COVID-19 Pandemic in Outpatient Obstetrics and Gynecology Patients; a Randomized Controlled Trial
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.
Read the 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
- Being tested
- "Calm" is a mindfulness meditation mobile app
- Keywords
- COVID-19, mindfulness meditation
- Medical subject headings
- Anxiety Disorders, Parasomnias, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Calm" is a mindfulness meditation mobile appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - access to meditation app | Experimental | Will receive a 30-day free trial of the mobile meditation app "Calm" on study day 0 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Completed study Day 30
Secondary outcomes (5)
Hospital Anxiety and Depression Scale
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.
Measured: Completed study Day 0, study Day 14, and study Day 30
PROMIS Sleep Disturbance Short Form Survey
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.
Measured: Completed study Day 0, study Day 14, and study Day 30
Adherence
Usage data from mobile app, minutes per day used, days per week used
Measured: From Day 0 to Day 30
Participant Satisfaction
Investigator developed satisfaction questionnaire completed on Day 30, 13 questions in length and measured with 5-point Likert scale.
Measured: Completed study Day 30
Coronavirus Questionnaire
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.
Measured: Completed study Day 0 and study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start13 Apr 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Bailey Smith, University of Arizona
- Investigators
- Mike Foley, Study director, Director Department of Obstetrics and Gynecology BUMCP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329533
- Sponsor's protocol ID
- 2003524869
- Status last verified
- Nov 2020
- First submitted
- 26 Mar 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31237569Huberty 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.
PubMed 31682582Huberty 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.
PubMed 32039812Nery 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.
PubMed 30328241Kanter 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.
PubMed 27116196Weston 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.
PubMed 31449907Smith 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.
PubMed 33957663
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mobile Meditation App on Stress During COVID-19 Pandemic in Outpatient Obstetrics and Gynecology Patients; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04329533
- Acronym / sponsor ID
- 2003524869
- Conditions
- Perceived Stress, Anxiety, Sleep Disturbance
- Keywords
- COVID-19, mindfulness meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - access to meditation app | Experimental | Other: "Calm" is a mindfulness meditation mobile appWill receive a 30-day free trial of the mobile meditation app "Calm" on study day 0 |
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- No access to a smart phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Calm" is a mindfulness meditation mobile appMindfulness 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. | Other | Intervention Group - access to meditation app |
Primary outcome
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.
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.
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.
5 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Completed study Day 0, study Day 14, and study Day 30
PROMIS Sleep Disturbance Short Form Survey
Time frame: Completed study Day 0, study Day 14, and study Day 30
Adherence
Time frame: From Day 0 to Day 30
Participant Satisfaction
Time frame: Completed study Day 30
Coronavirus Questionnaire
Time frame: Completed study Day 0 and study Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 31237569Huberty 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.
- Background: PubMed 31682582Huberty 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.
- Background: PubMed 32039812Huberty 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.
- Background: PubMed 30328241Nery 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.
- Background: PubMed 27116196Kanter 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.
- Background: PubMed 31449907Weston 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.
- Derived from this study: PubMed 33957663Smith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Foley study director
Director Department of Obstetrics and Gynecology BUMCP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Calm" is a mindfulness meditation mobile app in people with Perceived Stress and Anxiety, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Completed study Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04329533, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.