Occupational StressWRSNCT04948255
Measuring Work-Related Stress in Primary Care in the Covid-19 Pandemic
An observational study of Occupational Stress and Covid19, run by Dr. Faizan Awan at 1 site in United Kingdom.
Trial summary
This prospective cohort study was designed to assess WRS amongst clinical and non-clinical staff in a primary healthcare setting using a validated tool with a view to developing an evidence base to form a historical and comparative record during the Covid-19 pandemic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress, Covid19
- What is being tested?
- Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stress
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 29 Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult health professionals and administration staff
Who may be able to join
- Primary healthcare staff working at the Gill Medical Centre for at least two months prior to assessment.
Who cannot join
- Any staff member employed for less than two months, those who were off work due to non- stress related long-term leave or incomplete submissions.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Gill Medical Centre
Salford, Greater Manchester, M28 3DR
About this study
Official title: Work-Related Stress Amongst a Primary Care Workforce in Greater Manchester, United Kingdom Before and During the Covid-19 Pandemic
This prospective cohort study was designed to assess WRS amongst clinical and non-clinical staff in a primary healthcare setting using a validated tool with a view to developing an evidence base to form a historical and comparative record during the Covid-19 pandemic.
Read the detailed description
Work-related stress (WRS) is the second most common cause of occupational ill health in the United Kingdom. Studies suggest that during the Covid-19 pandemic, an increased prevalence of stress-related disorders was reported amongst healthcare workers. WRS can be assessed using the Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) and is used to compare changes to WRS across six domains over time. Lower scores in domains indicate higher WRS experienced by workers. Increases in the score in subsequent assessments indicate improvements to WRS. The MSIT was distributed to 23 primary care clinical and non-clinical staff in a medical centre in Greater Manchester, United Kingdom in March, 2019. 18 responses were received from 23 staff (78% response rate), establishing a baseline. In May, 2020, the authors decided to reanalyse the effect of the Covid-19 pandemic on WRS upon the same population. The MSIT was redistributed in March 2021, with 14 responses from 20 staff (70% response rate). Microsoft Excel's data analysis was applied to the results. WRS across the practice increased by 7% in demands, 4% in control and 2% in role domains and improved by 3% in support, 3% in relationships and 2% in change domains. The results are in keeping with the global picture of evolving WRS amongst healthcare staff during the pandemic. Monitoring and addressing WRS regularly helps maintain system-wide resilience when faced with unexpected or unprecedented change. Comparing these results with WRS in other healthcare systems would be a useful next step.
- Conditions
- Occupational Stress, Covid19
- Being tested
- Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stress
- Keywords
- Pandemics, Primary health care
- Medical subject headings
- Occupational Stress, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stressOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Workers at the Gill Medical Centre | Clinical and non-clinical staff at the Gill Medical Centre will complete a validated stress questionnaire during the Covid-19 pandemic. A baseline was established in May, 2019. Receives: Other: Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of stress across the workforce
Work-related stress (WRS) is measured using the Management Standards Indicator Tool (MSIT) on a Likert scale of 1-5 with a higher number indicating less WRS. A measurement is made at baseline and during the Covid-19 pandemic.
Measured: 24 months
Secondary outcomes (1)
Measurement of stress by type of role
WRS measured using MSIT across three different primary healthcare roles - doctors, other clinicians and administrators - at baseline from 2019 and during the Covid-19 pandemic
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Apr 2019
- Primary completion29 Mar 2021
- Study completion29 Jun 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Faizan Awan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Faizan Awan, The Gill Medical Centre
- Investigators
- Ashleigh Ward, MBChB, Principal investigator, Salford Royal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948255
- Sponsor's protocol ID
- 302893
- Acronym
- WRS
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of collected data with researchers using the same tool to assess work-related stress.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-Related Stress Amongst a Primary Care Workforce in Greater Manchester, United Kingdom Before and During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04948255
- Acronym / sponsor ID
- WRS / 302893
- Conditions
- Occupational Stress, Covid19
- Keywords
- Pandemics, Primary health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dr. Faizan AwanUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 1 Jul 2021 (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.
This prospective cohort study was designed to assess WRS amongst clinical and non-clinical staff in a primary healthcare setting using a validated tool with a view to developing an evidence base to form a historical and comparative record during the Covid-19 pandemic.
Detailed description
Work-related stress (WRS) is the second most common cause of occupational ill health in the United Kingdom. Studies suggest that during the Covid-19 pandemic, an increased prevalence of stress-related disorders was reported amongst healthcare workers. WRS can be assessed using the Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) and is used to compare changes to WRS across six domains over time. Lower scores in domains indicate higher WRS experienced by workers. Increases in the score in subsequent assessments indicate improvements to WRS. The MSIT was distributed to 23 primary care clinical and non-clinical staff in a medical centre in Greater Manchester, United Kingdom in March, 2019. 18 responses were received from 23 staff (78% response rate), establishing a baseline. In May, 2020, the authors decided to reanalyse the effect of the Covid-19 pandemic on WRS upon the same population. The MSIT was redistributed in March 2021, with 14 responses from 20 staff (70% response rate). Microsoft Excel's data analysis was applied to the results. WRS across the practice increased by 7% in demands, 4% in control and 2% in role domains and improved by 3% in support, 3% in relationships and 2% in change domains. The results are in keeping with the global picture of evolving WRS amongst healthcare staff during the pandemic. Monitoring and addressing WRS regularly helps maintain system-wide resilience when faced with unexpected or unprecedented change. Comparing these results with WRS in other healthcare systems would be a useful next step.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare Workers at the Gill Medical Centre | – | Other: Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stressClinical and non-clinical staff at the Gill Medical Centre will complete a validated stress questionnaire during the Covid-19 pandemic. A baseline was established in May, 2019. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult health professionals and administration staff
Key inclusion criteria (1 listed)
- Primary healthcare staff working at the Gill Medical Centre for at least two months prior to assessment.
Key exclusion criteria (1 listed)
- Any staff member employed for less than two months, those who were off work due to non- stress related long-term leave or incomplete submissions.
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 |
|---|---|---|
| Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stressQuestionnaire | Other | Healthcare Workers at the Gill Medical Centre |
Primary outcome
Measurement of stress across the workforce
Time frame: 24 months
Work-related stress (WRS) is measured using the Management Standards Indicator Tool (MSIT) on a Likert scale of 1-5 with a higher number indicating less WRS. A measurement is made at baseline and during the Covid-19 pandemic.
1 secondary outcome
Measurement of stress by type of role
Time frame: 24 months
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 1 Jul 2021.
- Individual participant dataSharing planned: Yes. Sharing of collected data with researchers using the same tool to assess work-related stress.
Related trials for Occupational Stress
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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.
Ashleigh Ward, MBChB principal investigator
Salford Royal Hospital
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 Occupational Stress and Covid19, run by Dr. Faizan Awan 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 1 inclusion and 1 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 1 Jul 2021. 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 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?
Measurement of stress across the workforce (time frame: 24 months). 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 1 Jul 2021.