Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
Primary Purpose
COVID-19 Infection
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Media Intervention
Meditation Therapy
Quality-of-Life Assessment
Questionnaire Administration
Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 Infection
Eligibility Criteria
Inclusion Criteria:
- Participants must be able to read and understand English
- Must be employed at MD Anderson Cancer Center
Exclusion Criteria:
- Epilepsy
- Brain tumor
- Brain aneurysm
- Pregnant or trying to get pregnant
- Brain bleeding in the past 1 year
- Recent abdominal surgery and not cleared to exercise
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (video, breathing techniques, meditation)
Arm Description
Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.
Outcomes
Primary Outcome Measures
Number of Participants Recruited to the Study (Feasibility)
To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic. Feasibility will be defined as recruitment of 50 participants to the study within 2 months.
Number of Participants Who Perceived the Intervention as Useful
Defined as more than 50% of participants perceive the intervention as useful. Meditation perception questions were asked such as usefulness, feeling at peace, hopeful, or relaxed, and responses were recorded as strongly agree, agree, neutral, disagree, and strongly disagree at weeks 1 and 4.
Secondary Outcome Measures
Change in Resilience
Measured by the Brief Resilient Coping Scale among health care workers questionnaire.
Perceive Stress and Psychological Impact
Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.
Breath Holding Time
Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.
Adherence to the Practice
Will determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).
Full Information
NCT ID
NCT04482647
First Posted
July 21, 2020
Last Updated
October 2, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04482647
Brief Title
Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
Official Title
Breathing Techniques and Meditation for Health Care Workers During COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase I trial investigates breathing techniques and meditation for health care workers during COVID-19 pandemic. Breathing techniques and medication may help manage stress and improve lung health. The goal of this trial is to learn if breathing techniques and meditation may help to reduce stress and improve lung health in health care workers during the COVID-19 pandemic.
Detailed Description
PRIMARY OBJECTIVE:
I. To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic.
SECONDARY OBJECTIVES:
I. To determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).
II. To determine the change in resilience, perceived stress and psychological impact from day 0 today 28 as measured by the Brief Resilient Coping Scale (BRCS), Perceived Stress Scale (PSS4), and COVID-19 Stress among health care workers questionnaire.
III. To determine the changes in breath holding time measured weekly for 4 weeks.
IV. To determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.
OUTLINE:
Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes twice daily (BID) for 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (video, breathing techniques, meditation)
Arm Type
Experimental
Arm Description
Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.
Intervention Type
Other
Intervention Name(s)
Media Intervention
Intervention Description
View instructional video
Intervention Type
Procedure
Intervention Name(s)
Meditation Therapy
Other Intervention Name(s)
Meditation
Intervention Description
Perform meditation
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Yoga
Other Intervention Name(s)
Yoga Therapy
Intervention Description
Perform breathing techniques
Primary Outcome Measure Information:
Title
Number of Participants Recruited to the Study (Feasibility)
Description
To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic. Feasibility will be defined as recruitment of 50 participants to the study within 2 months.
Time Frame
Within 2 months
Title
Number of Participants Who Perceived the Intervention as Useful
Description
Defined as more than 50% of participants perceive the intervention as useful. Meditation perception questions were asked such as usefulness, feeling at peace, hopeful, or relaxed, and responses were recorded as strongly agree, agree, neutral, disagree, and strongly disagree at weeks 1 and 4.
Time Frame
Week 1 and Week 4
Secondary Outcome Measure Information:
Title
Change in Resilience
Description
Measured by the Brief Resilient Coping Scale among health care workers questionnaire.
Time Frame
2 years
Title
Perceive Stress and Psychological Impact
Description
Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.
Time Frame
2 years
Title
Breath Holding Time
Description
Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.
Time Frame
2 years
Title
Adherence to the Practice
Description
Will determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be able to read and understand English
Must be employed at MD Anderson Cancer Center
Exclusion Criteria:
Epilepsy
Brain tumor
Brain aneurysm
Pregnant or trying to get pregnant
Brain bleeding in the past 1 year
Recent abdominal surgery and not cleared to exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santhosshi Narayanan
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33835830
Citation
Narayanan S, Tennison J, Cohen L, Urso C, Subramaniam B, Bruera E. Yoga-Based Breathing Techniques for Health Care Workers During COVID-19 Pandemic: Interests, Feasibility, and Acceptance. J Altern Complement Med. 2021 Aug;27(8):706-709. doi: 10.1089/acm.2020.0536. Epub 2021 Apr 9.
Results Reference
derived
Learn more about this trial
Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
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