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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04482647
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 52.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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:

1. To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic.

SECONDARY OBJECTIVES:

1. 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).

2. 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.

3. To determine the changes in breath holding time measured weekly for 4 weeks.

4. 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 Design

• Study Type: Interventional
• Actual Enrollment: 100 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: Jun 17, 2020
• Actual Primary Completion Date: Nov 5, 2020
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

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 Names: Meditation ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment ; Other: Questionnaire Administration; Ancillary studies; Procedure: Yoga; Perform breathing techniques; Other Names: Yoga Therapy

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Change in Resilience [2 years]

   Measured by the Brief Resilient Coping Scale among health care workers questionnaire.

2. Perceive Stress and Psychological Impact [2 years]

   Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.

3. Breath Holding Time [2 years]

   Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.

4. Adherence to the Practice [2 years]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Santhosshi Narayanan, M.D. Anderson Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 19, 2020

More Information

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04482647
• Other Study ID Numbers: 2020-0483; NCI-2020-04931; 2020-0483
• First Posted: Jul 22, 2020
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

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.

Arm/Group Title	Supportive Care (Video, Breathing Techniques, Meditation)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	100
COMPLETED	88
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Supportive Care (Video, Breathing Techniques, Meditation)
Arm/Group Description	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.
Overall Participants	100
Age, Customized (Count of Participants)
26-35 years	33 33%
36-45 years	22 22%
46-55 years	25 25%
56-65 years	18 18%
Above 66 years	2 2%
Sex: Female, Male (Count of Participants)
Female	88 88%
Male	12 12%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	20 20%
Not Hispanic or Latino	72 72%
Unknown or Not Reported	8 8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	19 19%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	17 17%
White	60 60%
More than one race	0 0%
Unknown or Not Reported	4 4%
Region of Enrollment (participants) [Number]
United States	100 100%
Education (Count of Participants)
Junior/High	9 9%
College	20 20%
Masters or higher	71 71%
Religion (Count of Participants)
Catholic	32 32%
Protestant	33 33%
None	20 20%
Other	15 15%
Occupation (Count of Participants)
Clinical role	28 28%
Administration	38 38%
Research	27 27%
Unknown	7 7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Recruited to the Study (Feasibility)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Video, Breathing Techniques, Meditation)
Arm/Group Description	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.
Measure Participants	100
Count of Participants [Participants]	100 100%

2. Primary Outcome

Title	Number of Participants Who Perceived the Intervention as Useful
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Supportive Care (Video, Breathing Techniques, Meditation)
Arm/Group Description	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.
Measure Participants	100
Week 1	69 69%
Week 4	56 56%

3. Secondary Outcome

Title	Change in Resilience
Description	Measured by the Brief Resilient Coping Scale among health care workers questionnaire.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Perceive Stress and Psychological Impact
Description	Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Breath Holding Time
Description	Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Adherence to the Practice
Description	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	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	adverse event data were collected at week 1 and week 4
Arm/Group Title	Supportive Care (Video, Breathing Techniques, Meditation)
Arm/Group Description	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.
All Cause Mortality
	Supportive Care (Video, Breathing Techniques, Meditation)
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Serious Adverse Events
	Supportive Care (Video, Breathing Techniques, Meditation)
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Other (Not Including Serious) Adverse Events
	Supportive Care (Video, Breathing Techniques, Meditation)
	Affected / at Risk (%)	# Events
Total	0/100 (0%)

Limitations/Caveats

Reporting Results for Primary Outcome Measures due to the PCD has been met.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.