NCT04858815

Brief Summary

Mind body exercises have long been used as a way for individuals to reduce stress and improve well-being. Recent studies indicate that yogic breathing (YB, also known as pranayama) could potentially impact both the mind and body by engaging both the physiological and neural elements and can thus be a specific tool that can be utilized by healthcare workers to combat burnout and decrease perceived levels of stress. Our aim is to understand and measure both subjectively and objectively the effects of long-term yogic breathing on stress levels in anesthesia personnel. This will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center. The primary aim of the trial is to estimate the correlation between participant stress with average duration of yogic breathing over time. Secondarily the feasibility of implementing yogic breathing practices among anesthesiology practitioners will be evaluated. Feasibility measures will include recruitment rates, retention at 1year follow-up, and adherence to the yogic breathing program at 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2022

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

April 21, 2021

Last Update Submit

October 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation of participant stress with average duration of yogic breathing over time

    The study will estimate the efficacy of self-administered yogic breathing on participant stress over time using (a) cortisol levels measured in hair and (b) using validated survey instruments estimated as the change in stress from baseline to 12 months. The primary measure of efficacy is correlation between cortisol/stress levels with average weekly duration of yogic breathing in minutes.

    baseline & 12 month visit

Study Arms (1)

Administration of yogic breathing program

EXPERIMENTAL

This will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a self-administered yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center.

Behavioral: yogic breathing

Interventions

yogic breathingBEHAVIORAL

participation in yogic breathing

Administration of yogic breathing program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All clinical members of the MUSC anesthesia department (Attending physicians, resident physicians, and CRNAs)

You may not qualify if:

  • Pregnancy (or anticipated pregnancy)
  • chronic steroid use
  • inadequate hair length for testing (less than 3cm at the back of the head)
  • residents with anticipated graduation within the next one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Grayce Davis, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single arm longitudinal trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 26, 2021

Study Start

April 26, 2021

Primary Completion

June 7, 2022

Study Completion

July 7, 2022

Last Updated

October 24, 2024

Record last verified: 2024-10

Locations