COVID-19 Infection
Conditions
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.
Interventions
OTHERMedia Intervention
View instructional video
PROCEDUREMeditation Therapy
Perform meditation
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDUREYoga
Perform breathing techniques
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Recruited to the Study (Feasibility) | 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. |
| Number of Participants Who Perceived the Intervention as Useful | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resilience | 4 weeks | Measured by the Brief Resilient Coping Scale among health care workers questionnaire. |
| Perceive Stress and Psychological Impact | 4 weeks | Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire. |
| Breath Holding Time | 4 weeks | 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 | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSanthosshi Narayanan
M.D. Anderson Cancer Center
Participant flow
Recruitment details
The purpose of this study is to determine the effects of web-based breathing techniques and meditation on lung health and building resilience among health care workers dealing with the COVID-19 pandemic.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Supportive Care (Video, Breathing Techniques, Meditation) |
|---|---|
| Age, Customized 26-35 years | 33 Participants |
| Age, Customized 36-45 years | 22 Participants |
| Age, Customized 46-55 years | 25 Participants |
| Age, Customized 56-65 years | 18 Participants |
| Age, Customized Above 66 years | 2 Participants |
| Education College | 20 Participants |
| Education Junior/High | 9 Participants |
| Education Masters or higher | 71 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Occupation Administration | 38 Participants |
| Occupation Clinical role | 28 Participants |
| Occupation Research | 27 Participants |
| Occupation Unknown | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 100 participants |
| Religion Catholic | 32 Participants |
| Religion None | 20 Participants |
| Religion Other | 15 Participants |
| Religion Protestant | 33 Participants |
| Sex: Female, Male Female | 88 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
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.
Time frame: Within 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Video, Breathing Techniques, Meditation) | Number of Participants Recruited to the Study (Feasibility) | 100 Participants |
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.
Time frame: Week 1 and Week 4
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Supportive Care (Video, Breathing Techniques, Meditation) | Number of Participants Who Perceived the Intervention as Useful | Week 1 | 69 Participants |
| Supportive Care (Video, Breathing Techniques, Meditation) | Number of Participants Who Perceived the Intervention as Useful | Week 4 | 56 Participants |
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).
Time frame: 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.
Time frame: 4 weeks
Secondary
Change in Resilience
Measured by the Brief Resilient Coping Scale among health care workers questionnaire.
Time frame: 4 weeks
Secondary
Perceive Stress and Psychological Impact
Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.
Time frame: 4 weeks