StressNCT04481516
Yoga in NHS Health Care Workers With COVID-19 Related Stress
An observational study of Stress, run by Doncaster And Bassetlaw Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress
- What is being tested?
- Yoga
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2020to 28 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NHS staff members with self-reported stress due to COVID
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, DN2 5LT
About this study
Official title: Effect of Breathing-based Meditation (Sudarshan Kriya Yoga) in NHS Health Care Workers With Possible COVID-19 Related Stress and Anxiety Disorder
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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
SKY Yoga
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 weeks
Secondary outcomes (3)
Alleviated stress 1 - medium 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
Measured: 3-6 months
Alleviated stress 2 - medium 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
Measured: 3-6 months
Alleviated stress 3 - medium 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
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Jul 2020
- Primary completion28 Feb 2021
- Study completion28 Dec 2021
Why it stopped: Put on hold due to COVID and then withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doncaster And Bassetlaw Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venkata D Nagarajan, Principal investigator, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481516
- Sponsor's protocol ID
- DBH 1058/2020/HRAS
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2020
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be pseudonymised
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing-based Meditation (Sudarshan Kriya Yoga) in NHS Health Care Workers With Possible COVID-19 Related Stress and Anxiety Disorder
- ClinicalTrials.gov ID
- NCT04481516
- Acronym / sponsor ID
- DBH 1058/2020/HRAS
- Conditions
- Stress
- Keywords
- Stress, Yoga
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Put on hold due to COVID and then withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Doncaster And Bassetlaw Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga | – | Other: YogaSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NHS staff members with self-reported stress due to COVID
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaSKY Yoga | Other | Yoga |
Primary outcome
Alleviated stress 1 - short term
Time frame: 6 weeks
(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
Alleviated stress 2 - short term
Time frame: 6 weeks
(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
Alleviated stress 3 - short term
Time frame: 6 weeks
(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
3 secondary outcomes
Alleviated stress 1 - medium term
Time frame: 3-6 months
Alleviated stress 2 - medium term
Time frame: 3-6 months
Alleviated stress 3 - medium term
Time frame: 3-6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No. All data will be pseudonymised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkata D Nagarajan principal investigator
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by Doncaster And Bassetlaw Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alleviated stress 1 - short term (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.