<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481516</url>
  </required_header>
  <id_info>
    <org_study_id>DBH 1058/2020/HRAS</org_study_id>
    <nct_id>NCT04481516</nct_id>
  </id_info>
  <brief_title>Yoga in NHS Health Care Workers With COVID-19 Related Stress</brief_title>
  <official_title>Effect of Breathing-based Meditation (Sudarshan Kriya Yoga) in NHS Health Care Workers With Possible COVID-19 Related Stress and Anxiety Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Doncaster And Bassetlaw Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Doncaster And Bassetlaw Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent reports have highlighted Covid-19 related increase in levels of depression and stress&#xD;
      related disorders in the health care professionals. Pranayama (ancient yogic breathing&#xD;
      techniques) helps harmonizing breathing by regular voluntary control of breath.&#xD;
&#xD;
      Yoga has been shown to modulate autonomic nervous functions of the brain. Sudarshan kriya&#xD;
      Yoga (SKY) is a unique form of pranayama taught by ''Art of Living UK'' a non-profit&#xD;
      organization -for over two decades. SKY involves simple rhythmic breathing technique (easy to&#xD;
      practice) that aims at harmonizing body, mind and emotions. Sudarshan kriya yoga (SKY) has&#xD;
      been shown to be beneficial in reducing levels of stress, anxiety and depression. This&#xD;
      breathing based meditation technique has previously been shown to be beneficial in&#xD;
      post-traumatic stress disorder.&#xD;
&#xD;
      In this pilot study the aim is to assess the feasibility and effect of SKY in NHS health care&#xD;
      workers with possible Covid-19 related stress and anxiety disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the current pilot study the aim is to assess the feasibility and effect of SKY in NHS&#xD;
      health care workers with possible Covid related stress and anxiety disorder. Study&#xD;
      participants are staff members of Doncaster and Bassetlaw Hospitals NHS Foundation Trust who&#xD;
      may be affected Covid related stress and anxiety disorder.&#xD;
&#xD;
      This is a paperless study with all the information including participant information, consent&#xD;
      forms and link to questionnaires sent via the trust e-mail.&#xD;
&#xD;
      Information about the study would be advertised via trust intranet, trust facebook page, and&#xD;
      through flyers across various sites within the trust. Potential participants who are&#xD;
      interested to know more information would be encouraged to contact the research team on&#xD;
      dbth.sky.yoga@nhs.net by using their trust email.&#xD;
&#xD;
      They would then be sent a generalised anxiety disorder (GAD-7) questionnaire to answer via&#xD;
      e-mail and they would be eligible to participate if their GAD-7 score is ≥5 which implies&#xD;
      they have mild or more sever form of anxiety disorder.&#xD;
&#xD;
      They would then be sent an invitation letter, participant information leaflet and consent&#xD;
      form via e-mail. They would also be provided an opportunity to talk to a research team member&#xD;
      via telephone. They would be enrolled into the study after receipt of their consent via&#xD;
      e-mail and they will be provided with a unique identifier number (which would be used for the&#xD;
      rest of the study). Participants receive online tutorial on breathing based meditation (SKY)&#xD;
      for about 4-5 hours spread over 3 sessions using Zoom platform from an 'Art of Living'&#xD;
      certified yoga teacher. They are subsequently encouraged to practice this technique for about&#xD;
      20 mins a day. They are also offered an optional online group session lasting 20mins, 4 days&#xD;
      a week for the first 6 weeks and subsequently once a week for the duration of the study.&#xD;
&#xD;
      They are sent a link, to their trust email, to access questionnaire about their symptoms and&#xD;
      health which they will need to answer at onset, 6 weeks, 3 months and at conclusion of the&#xD;
      study (6 months). They will need to provide personal information about their medical&#xD;
      condition and their medications at the time of enrolment. On completion of the study results&#xD;
      would be analysed and final outcome presented. Study findings would be disseminated in&#xD;
      medical fraternity by presentation in medical conference and publication in a peer reviewed&#xD;
      journal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Put on hold due to COVID and then withdrawn.&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 17, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Alleviated stress 1 - short term</measure>
    <time_frame>6 weeks</time_frame>
    <description>(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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alleviated stress 2 - short term</measure>
    <time_frame>6 weeks</time_frame>
    <description>(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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alleviated stress 3 - short term</measure>
    <time_frame>6 weeks</time_frame>
    <description>(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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alleviated stress 1 - medium term</measure>
    <time_frame>3-6 months</time_frame>
    <description>(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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alleviated stress 2 - medium term</measure>
    <time_frame>3-6 months</time_frame>
    <description>(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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alleviated stress 3 - medium term</measure>
    <time_frame>3-6 months</time_frame>
    <description>(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</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <description>Single arm only 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>SKY Yoga</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        NHS staff members with self-reported stress due to COVID&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male / Female aged over 18 years&#xD;
&#xD;
          -  Member of DBHFT&#xD;
&#xD;
          -  Score of ≥ 5 on generalized anxiety disorder (GAD-7) questionnaire&#xD;
&#xD;
          -  Fully able to understand the nature of the study with sufficient chance to read PIL&#xD;
             and commitment to participate in the online Yoga schedule&#xD;
&#xD;
          -  Willingness to enter data regularly by answering online questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Significant other co-morbid conditions that would preclude regular Yoga practice&#xD;
&#xD;
          -  Chronic medical conditions necessitating hospital admission in the last 6 months or&#xD;
             history of significant bipolar disorder&#xD;
&#xD;
          -  Patients taking part in other research studies during the study period&#xD;
&#xD;
          -  Inability to understand study requirements&#xD;
&#xD;
          -  Patients who have been on any form of regular Yoga schedule in the previous 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Venkata D Nagarajan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Doncaster</city>
        <state>South Yorkshire</state>
        <zip>DN2 5LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>October 21, 2022</last_update_submitted>
  <last_update_submitted_qc>October 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Yoga</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data will be pseudonymised</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481516
org study id: DBH 1058/2020/HRAS
nct id: NCT04481516
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
In the current pilot study the aim is to assess the feasibility and effect of SKY in NHS
      health care workers with possible Covid related stress and anxiety disorder. Study
      participants are staff members of Doncaster and Bassetlaw Hospitals NHS Foundation Trust who
      may be affected Covid related stress and anxiety disorder.

      This is a paperless study with all the information including participant information, consent
      forms and link to questionnaires sent via the trust e-mail.

      Information about the study would be advertised via trust intranet, trust facebook page, and
      through flyers across various sites within the trust. Potential participants who are
      interested to know more information would be encouraged to contact the research team on
      dbth.sky.yoga@nhs.net by using their trust email.

      They would then be sent a generalised anxiety disorder (GAD-7) questionnaire to answer via
      e-mail and they would be eligible to participate if their GAD-7 score is ≥5 which implies
      they have mild or more sever form of anxiety disorder.

      They would then be sent an invitation letter, participant information leaflet and consent
      form via e-mail. They would also be provided an opportunity to talk to a research team member
      via telephone. They would be enrolled into the study after receipt of their consent via
      e-mail and they will be provided with a unique identifier number (which would be used for the
      rest of the study). Participants receive online tutorial on breathing based meditation (SKY)
      for about 4-5 hours spread over 3 sessions using Zoom platform from an 'Art of Living'
      certified yoga teacher. They are subsequently encouraged to practice this technique for about
      20 mins a day. They are also offered an optional online group session lasting 20mins, 4 days
      a week for the first 6 weeks and subsequently once a week for the duration of the study.

      They are sent a link, to their trust email, to access questionnaire about their symptoms and
      health which they will need to answer at onset, 6 weeks, 3 months and at conclusion of the
      study (6 months). They will need to provide personal information about their medical
      condition and their medications at the time of enrolment. On completion of the study results
      would be analysed and final outcome presented. Study findings would be disseminated in
      medical fraternity by presentation in medical conference and publication in a peer reviewed
      journal.
observational model: Cohort
time perspective: Prospective
measure: Alleviated stress 1 - short term
time frame: 6 weeks
description: (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
measure: Alleviated stress 2 - short term
time frame: 6 weeks
description: (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
measure: Alleviated stress 3 - short term
time frame: 6 weeks
description: (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
measure: Alleviated stress 1 - medium term
time frame: 3-6 months
description: (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
measure: Alleviated stress 2 - medium term
time frame: 3-6 months
description: (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
measure: Alleviated stress 3 - medium term
time frame: 3-6 months
description: (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
arm group label: Yoga
description: Single arm only 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.
intervention type: Other
intervention name: Yoga
description: SKY Yoga
arm group label: Yoga
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Venkata D Nagarajan
role: Principal Investigator
affiliation: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: All data will be pseudonymised