Clinical trial NCT04482647: Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic
Official title: Breathing Techniques and Meditation for Health Care Workers During COVID-19
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19 Infection
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-22
Enrollment: 100
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Recruited to the Study (Feasibility)
timeFrame: Within 2 months
measure: Number of Participants Who Perceived the Intervention as Useful
timeFrame: Week 1 and Week 4
Secondary outcomes:
measure: Change in Resilience
timeFrame: 4 weeks
measure: Perceive Stress and Psychological Impact
timeFrame: 4 weeks
measure: Breath Holding Time
timeFrame: 4 weeks
measure: Adherence to the Practice
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Santhosshi Narayanan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.