Clinical trial NCT04481516: Yoga in NHS Health Care Workers With COVID-19 Related Stress
Official title: Effect of Breathing-based Meditation (Sudarshan Kriya Yoga) in NHS Health Care Workers With Possible COVID-19 Related Stress and Anxiety Disorder
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stress
Keywords: Stress
Yoga
Lead sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NHS staff members with self-reported stress due to COVID

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Alleviated stress 1 - short term
timeFrame: 6 weeks
measure: Alleviated stress 2 - short term
timeFrame: 6 weeks
measure: Alleviated stress 3 - short term
timeFrame: 6 weeks
Secondary outcomes:
measure: Alleviated stress 1 - medium term
timeFrame: 3-6 months
measure: Alleviated stress 2 - medium term
timeFrame: 3-6 months
measure: Alleviated stress 3 - medium term
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
name: Venkata D Nagarajan
role: PRINCIPAL_INVESTIGATOR
References: