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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04931 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0483 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (video, breathing techniques, meditation) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Media Intervention | Other | View instructional video |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resilience | Measured by the Brief Resilient Coping Scale among health care workers questionnaire. | 4 weeks |
| Perceive Stress and Psychological Impact | Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santhosshi Narayanan | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38546421 | Derived | 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. | |
| 33835830 | Derived |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Within 2 months |
|
|
adverse event data were collected at week 1 and week 4
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Reporting Results for Primary Outcome Measures due to the PCD has been met.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Santhosshi Narayanan, MD-Assistant Professor, Integrative Medicine Program | UT MD Anderson Cancer Center | (346) 228-6676 | snarayanan2@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2020 | Jan 31, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2020 | Oct 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Meditation Therapy | Procedure | Perform meditation |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Yoga | Procedure | Perform breathing techniques |
|
|
| 4 weeks |
| 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 |
| 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 |
| 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. |
| Disliked the intervention |
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| No reasons specified |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Religion | Count of Participants | Participants |
|
| Occupation | Count of Participants | 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. | Posted | Count of Participants | Participants | Week 1 and Week 4 |
|
|
|
| Secondary | Change in Resilience | Measured by the Brief Resilient Coping Scale among health care workers questionnaire. | Not Posted | Nov 2027 | 4 weeks | Participants |
| Secondary | Perceive Stress and Psychological Impact | Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire. | Not Posted | Nov 2027 | 4 weeks | Participants |
| 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. | Not Posted | Nov 2027 | 4 weeks | 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). | Not Posted | Nov 2027 | 4 weeks | Participants |
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |