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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04482647
Other study ID # 2020-0483
Secondary ID NCI-2020-0493120
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date June 17, 2020
Est. completion date April 30, 2025

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Media Intervention
View instructional video
Procedure:
Meditation Therapy
Perform meditation
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Procedure:
Yoga
Perform breathing techniques

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 2 months
Primary 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. Week 1 and Week 4
Secondary Change in Resilience Measured by the Brief Resilient Coping Scale among health care workers questionnaire. 4 weeks
Secondary Perceive Stress and Psychological Impact Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire. 4 weeks
Secondary 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. 4 weeks
Secondary 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). 4 weeks
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