NCT04482647

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jun 2020Apr 2027

Study Start

First participant enrolled

June 17, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 16, 2022

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Expected
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

July 21, 2020

Results QC Date

February 1, 2022

Last Update Submit

November 13, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Change in Resilience

    4 weeks

  • Perceive Stress and Psychological Impact

    4 weeks

  • Breath Holding Time

    4 weeks

  • Adherence to the Practice

    4 weeks

Study Arms (1)

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.

Other: Media InterventionProcedure: Meditation TherapyOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationProcedure: Yoga

Interventions

View instructional video

Supportive Care (video, breathing techniques, meditation)

Perform meditation

Also known as: Meditation
Supportive Care (video, breathing techniques, meditation)

Ancillary studies

Also known as: Quality of Life Assessment
Supportive Care (video, breathing techniques, meditation)

Ancillary studies

Supportive Care (video, breathing techniques, meditation)
YogaPROCEDURE

Perform breathing techniques

Also known as: Yoga Therapy
Supportive Care (video, breathing techniques, meditation)

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be able to read and understand English
  • Must be employed at MD Anderson Cancer Center

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19

Interventions

MeditationYoga

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesExercise Movement TechniquesPhysical Therapy Modalities

Limitations and Caveats

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

Results Point of Contact

Title
Santhosshi Narayanan, MD-Assistant Professor, Integrative Medicine Program
Organization
UT MD Anderson Cancer Center

Study Officials

  • Santhosshi Narayanan

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 22, 2020

Study Start

June 17, 2020

Primary Completion

November 5, 2020

Study Completion (Estimated)

April 30, 2027

Last Updated

November 19, 2025

Results First Posted

February 16, 2022

Record last verified: 2025-11

Locations