- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04482647
Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
Breathing Techniques and Meditation for Health Care Workers During COVID-19
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Care (video, breathing techniques, meditation)
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.
|
Ancillary studies
Other Names:
Ancillary studies
View instructional video
Perform meditation
Other Names:
Perform breathing techniques
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Recruited to the Study (Feasibility)
Time Frame: Within 2 months
|
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.
|
Within 2 months
|
|
Number of Participants Who Perceived the Intervention as Useful
Time Frame: Week 1 and Week 4
|
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.
|
Week 1 and Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Resilience
Time Frame: 4 weeks
|
Measured by the Brief Resilient Coping Scale among health care workers questionnaire.
|
4 weeks
|
|
Perceive Stress and Psychological Impact
Time Frame: 4 weeks
|
Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.
|
4 weeks
|
|
Breath Holding Time
Time Frame: 4 weeks
|
Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.
|
4 weeks
|
|
Adherence to the Practice
Time Frame: 4 weeks
|
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).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Santhosshi Narayanan, M.D. Anderson Cancer Center
Publications and helpful links
General Publications
- 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.
- Wagner RW, Mallaiah S, Anderson CR, Engle R, Vasu V, Bruera E, Subramaniam B, Cohen L, Narayanan S. Effects of the Brief Simha Kriya Breathing Practice for Health Care Workers During the COVID-19 Pandemic. J Integr Complement Med. 2024 Oct;30(10):970-977. doi: 10.1089/jicm.2023.0692. Epub 2024 Mar 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Relaxation Therapy
- Yoga
- Meditation
Other Study ID Numbers
- 2020-0483 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-04931 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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