Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Mindfulness Rounds in the Time of COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04431297
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Zahn, Icahn School of Medicine at Mount Sinai

Brief Summary:
Mindfulness education will be provided via a virtual platform to see if staff stress can be decreased during this time of pandemic.

Condition or disease Intervention/treatment Phase
Chronic Stress Other: Mindfulness Rounds Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Virtual Mindfulness Education Sessions on Staff Perceived Stress During COVID-19
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Health Care Workers
Voluntary participation in the virtual presentations
Other: Mindfulness Rounds
Virtually delivered mindfulness education sessions of 15-30 minutes, two times/week, for four weeks




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mount Sinai Hospital employee

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431297


Contacts
Layout table for location contacts
Contact: Jeffrey Zahn, MD 212-241-6426 jeffrey.zhan@mountsinai.org

Locations
Layout table for location information
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Principal Investigator: Jeffrey Zahn, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey Zahn, MD Icahn School of Medicine at Mount Sinai
Layout table for additonal information
Responsible Party: Jeffrey Zahn, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04431297    
Other Study ID Numbers: GCO 20-1022
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Zahn, Icahn School of Medicine at Mount Sinai:
Stress mindfulness