NCT04481516

Brief Summary

Recent reports have highlighted Covid-19 related increase in levels of depression and stress related disorders in the health care professionals. Pranayama (ancient yogic breathing techniques) helps harmonizing breathing by regular voluntary control of breath. Yoga has been shown to modulate autonomic nervous functions of the brain. Sudarshan kriya Yoga (SKY) is a unique form of pranayama taught by ''Art of Living UK'' a non-profit organization -for over two decades. SKY involves simple rhythmic breathing technique (easy to practice) that aims at harmonizing body, mind and emotions. Sudarshan kriya yoga (SKY) has been shown to be beneficial in reducing levels of stress, anxiety and depression. This breathing based meditation technique has previously been shown to be beneficial in post-traumatic stress disorder. In this pilot study the aim is to assess the feasibility and effect of SKY in NHS health care workers with possible Covid-19 related stress and anxiety disorder.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
Last Updated

July 8, 2024

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

July 1, 2020

Last Update Submit

July 5, 2024

Conditions

Keywords

StressYoga

Outcome Measures

Primary Outcomes (3)

  • Alleviated stress 1 - short term

    (1) To assess feasibility and efficacy of regularly supervised SKY in the NHS health care workers with possible Covid-19 related stress and anxiety disorder in the short term (6 weeks) by using Generalised Anxiety Disorder questionnaire score ranging from 0-21, higher score associated with worse outcome

    6 weeks

  • Alleviated stress 2 - short term

    (2) To assess feasibility and efficacy of regularly supervised SKY in the NHS health care workers with possible Covid-19 related stress and anxiety disorder in the short term (6 weeks) by using Medical Outcomes Study Questionnaire Short Form 36 Health Survey questionnaire score ranging from 36-149, higher score associated with worse outcome

    6 weeks

  • Alleviated stress 3 - short term

    (3) To assess feasibility and efficacy of regularly supervised SKY in the NHS health care workers with possible Covid-19 related stress and anxiety disorder in the short term (6 weeks) by using Patient Health Questionnaire questionnaire score ranging from 0-27, higher score associated with worse outcome

    6 weeks

Secondary Outcomes (3)

  • Alleviated stress 1 - medium term

    3-6 months

  • Alleviated stress 2 - medium term

    3-6 months

  • Alleviated stress 3 - medium term

    3-6 months

Study Arms (1)

Yoga

Single group study representing cohort of NHS health care workers with possible Covid-19 related stress and anxiety disorder. Participants act as their own controls pre and post regular practice of yoga technique.

Other: Yoga

Interventions

YogaOTHER

SKY Yoga

Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NHS staff members with self-reported stress due to COVID

You may qualify if:

  • Male / Female aged over 18 years
  • Member of DBHFT
  • Score of ≥ 5 on generalized anxiety disorder (GAD-7) questionnaire
  • Fully able to understand the nature of the study with sufficient chance to read PIL and commitment to participate in the online Yoga schedule
  • Willingness to enter data regularly by answering online questionnaire

You may not qualify if:

  • Under 18 years of age
  • Significant other co-morbid conditions that would preclude regular Yoga practice
  • Chronic medical conditions necessitating hospital admission in the last 6 months or history of significant bipolar disorder
  • Patients taking part in other research studies during the study period
  • Inability to understand study requirements
  • Patients who have been on any form of regular Yoga schedule in the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Venkata D Nagarajan

    Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 22, 2020

Study Start

July 1, 2020

Primary Completion

February 28, 2021

Study Completion

December 28, 2021

Last Updated

July 8, 2024

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

All data will be pseudonymised

Locations