Occupational StressNCT04313517
Yoga@Work Intervention to Reduce Work-related Stress Among Information Technology Workers
A study testing Yoga in people with Occupational Stress and Psychological Stress, run by Aarogyam UK at 4 sites in 4 countries.
Trial summary
Over the last several decades, occupational stress at workplace comprise a major burden. Office based work are more prone to sedentary lifestyle, postural issues, workplace stress, repetitive strain injury, poor employee health. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress, Psychological Stress
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 12 Jan 2019to 21 Sep 2019
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Information Technology employee, or trainee willing and able to participate in a 6-week self-care program during the work day.
- Willing to give informed consent
Who cannot join
- medical or psychiatric conditions limiting practice of yoga in general
- Cognitive impairment
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Yoga@Work Intervention to Reduce Work Related Stress Among Information Technology Workers: Waitlist Controlled Trial
Over the last several decades, occupational stress at workplace comprise a major burden. Office based work are more prone to sedentary lifestyle, postural issues, workplace stress, repetitive strain injury, poor employee health. Workplace wellness programs has been very feasible access to employees at their own convenience and need. Yoga@Work Program was developed to suit the need for information technology workers.
- Conditions
- Occupational Stress, Psychological Stress
- Being tested
- Yoga
- Medical subject headings
- Occupational Stress, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Each yoga session included warm-up practices (for the large joints, spine, and extremities), Simple postures (Asana), breathing exercises (pranayama) and meditation/relaxation. All the yoga participants were given handouts to practice everyday at work as its feasible
| Study group | Role | What they receive |
|---|---|---|
| Yoga@Work | Experimental | Yoga session were developed to practice at work anytime feasible. Receives: Other: Yoga |
| Wait list Control group | No intervention | Control group with no intervention. After Intervention period, group was offered same sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in occupational stress
Perceived Stress Scale
Measured: From baseline to 6-week post intervention
Secondary outcomes (1)
Mental health problems
General Health questionnaires consists of 12 items, each assessing the severity of a mental problem
Measured: From baseline to 6-week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start12 Jan 2019
- Primary completion18 Jun 2019
- Study completion21 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- Brunel University, NMP Medical Research Institute, Ananda Yoga (Hong Kong), Vrije Universiteit Brussel
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Aarogyam UKJaydeep Joshi, BAMS, Study director, Aarogyam UKMonomita Nandy, Study chair, Brunel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313517
- Sponsor's protocol ID
- AUI01
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga@Work Intervention to Reduce Work Related Stress Among Information Technology Workers: Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT04313517
- Acronym / sponsor ID
- AUI01
- Conditions
- Occupational Stress, Psychological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Brunel University, NMP Medical Research Institute, Ananda Yoga (Hong Kong), Vrije Universiteit Brussel
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 21 Sep 2019 (actual)
- First posted
- 18 Mar 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.
Over the last several decades, occupational stress at workplace comprise a major burden. Office based work are more prone to sedentary lifestyle, postural issues, workplace stress, repetitive strain injury, poor employee health. Workplace wellness programs has been very feasible access to employees at their own convenience and need. Yoga@Work Program was developed to suit the need for information technology workers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga@Work | Experimental | Other: YogaYoga session were developed to practice at work anytime feasible. |
| Wait list Control group | No intervention | –Control group with no intervention. After Intervention period, group was offered same sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Information Technology employee, or trainee willing and able to participate in a 6-week self-care program during the work day.
- Willing to give informed consent
Key exclusion criteria (2 listed)
- medical or psychiatric conditions limiting practice of yoga in general
- Cognitive impairment
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 |
|---|---|---|
| YogaEach yoga session included warm-up practices (for the large joints, spine, and extremities), Simple postures (Asana), breathing exercises (pranayama) and meditation/relaxation. All the yoga participants were given handouts to practice everyday at work as its feasible | Other | Yoga@Work |
Primary outcome
Reductions in occupational stress
Time frame: From baseline to 6-week post intervention
Perceived Stress Scale
1 secondary outcome
Mental health problems
Time frame: From baseline to 6-week post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Neha Sharma, PhD principal investigator
Aarogyam UK
Jaydeep Joshi, BAMS study director
Aarogyam UK
Monomita Nandy study chair
Brunel University
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Occupational Stress and Psychological Stress, run by Aarogyam UK at 4 sites in 4 countries.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Hong Kong, India, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reductions in occupational stress (time frame: From baseline to 6-week post intervention). 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 19 Mar 2020.