Chronic StressNCT04431297
Virtual Mindfulness Rounds in the Time of COVID-19 Pandemic
A study testing Mindfulness Rounds in people with Chronic Stress, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress
- What is being tested?
- Mindfulness Rounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 14 May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mount Sinai Hospital employee
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: The Impact of Virtual Mindfulness Education Sessions on Staff Perceived Stress During COVID-19
Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic.
Read the detailed description
Healthcare workers have been front and center in battling the COVID crisis. This is a situation the researchers could never have envisioned before it happened. Of course, this has triggered an inordinate amount of stress. Research shows that chronic stress leaves one imbalanced and one's health and happiness to suffer. Research has also demonstrated that how one thinks about stress determines how the body responds to it. Simple mindfulness practices provide healthier ways to deal with stress. In this study, the researchers will introduce modified mindfulness practices that can be practiced in the healthcare setting or at home. All of the practices are based on mindfulness principles. Mindfulness refers to a state of being present in the moment, on purpose, and without judgment. "Mindfulness Based Stress Reduction" is an 8 week, 2 hours/week curriculum that has shown results for over 40 years. All the practices in this study are adapted from that protocol.
The intervention includes several mindfulness practices including an awareness of breath focus instruction, breath-and-body coordination and awareness instruction, and instruction in identifying times to practice these exercises. The intervention will be delivered virtually 2-day/week, twice/day, for four weeks.
Effectiveness will be measured by the voluntary, anonymous submission of a Perceived Stress Scale, a validated survey tool to determine an individual's perceived stress level.
Participants will be healthcare workers and hospital staff in the Mount Sinai Hospital system.
- Conditions
- Chronic Stress
- Being tested
- Mindfulness Rounds
- Keywords
- Stress mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness RoundsOther
Virtually delivered mindfulness education sessions of 15-30 minutes, two times/week, for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Health Care Workers | Other | Voluntary participation in the virtual presentations Receives: Other: Mindfulness Rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale
Participants will file a 10 question validated survey tool call the Perceived Stress Scale (PSS) before and after the 4-week virtual educational intervention. Total scale range from 0 to 40, higher score indicates more perceived stress
Measured: baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start22 Mar 2021
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StressStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Zahn, Icahn School of Medicine at Mount Sinai
- Investigators
- Jeffrey Zahn, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431297
- Sponsor's protocol ID
- GCO 20-1022
- Status last verified
- Aug 2021
- First submitted
- 12 Jun 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Mindfulness Education Sessions on Staff Perceived Stress During COVID-19
- ClinicalTrials.gov ID
- NCT04431297
- Acronym / sponsor ID
- GCO 20-1022
- Conditions
- Chronic Stress
- Keywords
- Stress mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 16 Jun 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.
Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic.
Detailed description
Healthcare workers have been front and center in battling the COVID crisis. This is a situation the researchers could never have envisioned before it happened. Of course, this has triggered an inordinate amount of stress. Research shows that chronic stress leaves one imbalanced and one's health and happiness to suffer. Research has also demonstrated that how one thinks about stress determines how the body responds to it. Simple mindfulness practices provide healthier ways to deal with stress. In this study, the researchers will introduce modified mindfulness practices that can be practiced in the healthcare setting or at home. All of the practices are based on mindfulness principles. Mindfulness refers to a state of being present in the moment, on purpose, and without judgment. "Mindfulness Based Stress Reduction" is an 8 week, 2 hours/week curriculum that has shown results for over 40 years. All the practices in this study are adapted from that protocol.
The intervention includes several mindfulness practices including an awareness of breath focus instruction, breath-and-body coordination and awareness instruction, and instruction in identifying times to practice these exercises. The intervention will be delivered virtually 2-day/week, twice/day, for four weeks.
Effectiveness will be measured by the voluntary, anonymous submission of a Perceived Stress Scale, a validated survey tool to determine an individual's perceived stress level.
Participants will be healthcare workers and hospital staff in the Mount Sinai Hospital system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Care Workers | Other | Other: Mindfulness RoundsVoluntary participation in the virtual presentations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mount Sinai Hospital employee
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mindfulness RoundsVirtually delivered mindfulness education sessions of 15-30 minutes, two times/week, for four weeks | Other | Health Care Workers |
Primary outcome
Change in Perceived Stress Scale
Time frame: baseline and Week 6
Participants will file a 10 question validated survey tool call the Perceived Stress Scale (PSS) before and after the 4-week virtual educational intervention. Total scale range from 0 to 40, higher score indicates more perceived stress
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 20 Aug 2021.
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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.
Jeffrey Zahn, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Rounds in people with Chronic Stress, run by Icahn School of Medicine at Mount Sinai 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 1 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 20 Aug 2021. 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?
Change in Perceived Stress Scale (time frame: baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2021.