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Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic

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ClinicalTrials.gov Identifier: NCT04482647
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Other: Media Intervention Procedure: Meditation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Yoga Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Breathing Techniques and Meditation for Health Care Workers During COVID-19
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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.
Other: Media Intervention
View instructional video

Procedure: Meditation Therapy
Perform meditation
Other Name: Meditation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Yoga
Perform breathing techniques
Other Name: Yoga Therapy




Primary Outcome Measures :
  1. Study recruitment [ Time Frame: Within 2 months ]
    Feasibility will be defined as recruitment of 50 participants to the study within 2 months.

  2. Acceptability of study [ Time Frame: Up to 2 years ]
    Defined as more than 50% of participants perceive the intervention as useful.


Secondary Outcome Measures :
  1. Adherence to the practice [ Time Frame: Up to 28 days ]
    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).

  2. Change in resilience [ Time Frame: Day 0 to 28 ]
    Measured by the Brief Resilient Coping Scale among health care workers questionnaire.

  3. Perceive stress and psychological impact [ Time Frame: Day 0 to 28 ]
    Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.

  4. Breath holding time [ Time Frame: Up to 28 days ]
    Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT04482647


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Santhosshi Narayanan    346-228-6676    SNarayanan2@mdanderson.org   
Principal Investigator: Santhosshi Narayanan         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Santhosshi Narayanan M.D. Anderson Cancer Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04482647    
Other Study ID Numbers: 2020-0483
NCI-2020-04931 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0483 ( Other Identifier: M D Anderson Cancer Center )
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes