WellbeingNCT04749966
Blue Light Emergency Services Wellbeing Feasibility Study
An observational study of Wellbeing, run by Anglia Ruskin University at 1 site in United Kingdom.
Trial summary
Emergency Service teams operate in some of the most challenging workplaces and experience higher rates of mental ill health than the general population. Effective interventions are required to enhance wellbeing, but as a first step it is crucial to understand the context through which to develop these initiatives. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wellbeing
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2021to 27 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A purposive, non-probability sample will be selected and recruited comprising ten operational shift working staff from each of three emergency services (Essex Police, Essex County Fire and Rescue Service and East of England Ambulance Trust).
Who may be able to join
- are aged 18 or older
- full-time employees
- work shift patterns and will be on-duty during the study period
- are able to take part in and contribute to the study (see exclusion criteria below).
Who cannot join
- off-duty or on leave during the study period
- part-time (or on-call) employees
- not working shift patterns
- currently taking part in research that may impact on results, design or scientific value of this study (or other studies)
- not able to read or understand the English Language as it will not be possible to provide translation services for the study
- In addition, the results from the heart rate monitor may be unreliable with certain medical conditions and, as such, staff will not be able to take part if they have had a heart transplant or if they have a pacemaker, heart disease, atrial fibrillation, atrial flutter or uncontrolled thyroid disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Wellbeing Among Emergency Service Staff by Mapping Physiological Indicators and Subjective Mediators of Stress: An Observational Feasibility Study
Emergency Service teams operate in some of the most challenging workplaces and experience higher rates of mental ill health than the general population. Effective interventions are required to enhance wellbeing, but as a first step it is crucial to understand the context through which to develop these initiatives. This preliminary study will test the feasibility of implementing a larger study to map the relationship between physical responses associated with levels of stress (heart rate variability) and personal, social and organisational factors that mediate these responses. In doing so, it is hoped to provide an insight into factors that shape emergency staff members' response to stress to help develop and personalise wellbeing initiatives.
Read the detailed description
The study team is proposing a large study in the Essex Emergency Services to map the relationship between physiological indicators of stress and subjective mediators and, in doing, provide insight into factors that shape a staff members' response to stress, which could help to develop and personalise wellbeing initiatives.
However, before undertaking a large study it is proposed to establish operational feasibility. This feasibility study will enrol ten shift-working staff from each of three emergency services (Essex Police, Essex County Fire and Rescue Service and East of England Ambulance Service Trust). Over a 3-day period, we will evaluate participants' physiological response to stressors by measuring HRV (using Firstbeat Bodyguard 2 beat-to-beat heart rate monitor). During the same period, participants will keep a personal online journal of events during the day. As part of the lifestyle assessment, data from the heart rate monitor and journal will be analysed and participants will receive a Summary Report including information on their body's reaction to stress and how this may be managed. Following the lifestyle assessment, the research team will facilitate semi-structured interviews; they will use participants' lifestyle assessment Summary Reports to inform appropriate questions. The team will discuss subjective experiences with participants as well as their overall experience with the data collection process.
The objectives of the feasibility study are to:
- Evaluate feasibility of undertaking a larger definitive study in terms of:
- Willingness and eligibility of emergency services' staff to take part in the study
- Recruitment timeframe
- Participant adherence to lifestyle assessment protocols (including wearing a heart rate monitor and completing an online journal over a 3-day period)
- Proportion of participants in whom an interview is arranged and completed
- Feasibility of other operational aspects not included above.
- Undertake an initial evaluation of physiological indicators and subjective mediators of stress and identify any i) associations between them and ii) patterns that emerge between individual participants.
- Conditions
- Wellbeing
- Being tested
- This is an observational study, there are no interventions
- Keywords
- Emergency services, wellbeing, stress, physiological responses, subjective mediators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study, there are no interventionsOther
This is an observational study, there are no interventions
| Study group | Role | What they receive |
|---|---|---|
| Emergency services staff | Emergency Services staff recruited from the Ambulance, Police, and Fire and Rescue Services. Receives: Other: This is an observational study, there are no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study recruitment - the number of staff volunteering to take part
The number of staff volunteering to take part
Measured: From the start to the end of recruitment at each participating site, approximately 4 weeks
Feasibility of study recruitment - the proportion of staff targeted through study advertising who volunteer to take part
The proportion of staff estimated to have been targeted through study advertising who volunteer to take part
Measured: From the start to the end of recruitment at each participating site, approximately 4 weeks
Feasibility of study recruitment - the proportion of staff volunteering to take part in the study who are eligible
The proportion of staff volunteering to take part in the study who are eligible
Measured: From the start to the end of recruitment at each participating site, approximately 4 weeks
Adherence to heart rate monitoring during 3-day lifestyle assessment
The proportion of time the heart rate monitor was worn by participants measured using data collected by the monitor
Measured: At Day 3 of the lifestyle assessment
Adherence to completion of online journal during 3-day lifestyle assessment
The proportion of participants completing the journal
Measured: At Day 3 of the lifestyle assessment
Feasibility of conducting interviews
The proportion of participants in whom an interview is arranged and completed
Measured: On completion of interviews i.e. at approximately 8 weeks
Secondary outcomes (2)
Heart rate variance
Heart rate variance will be measured as a physiological indicator of stress via a heart rate monitoring device worn by each participant over a 3-day period.
Measured: Measured during lifestyle assessment over a period of 3 days - at approximately 3 weeks post-recruitment
Subjective mediators of stress
Subjective mediators include personal, social and organisational factors identified through semi-structured interviews. Qualitative thematic analysis techniques will be used to identify individual and group characteristics and subjective mediators associated with periods of stress.
Measured: On completion of interviews i.e. at approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start15 Feb 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellbeingStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Dippenaar, Principal investigator, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749966
- Sponsor's protocol ID
- 19_20_029
- Other IDs
- IRAS 278059
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Wellbeing Among Emergency Service Staff by Mapping Physiological Indicators and Subjective Mediators of Stress: An Observational Feasibility Study
- ClinicalTrials.gov ID
- NCT04749966
- Acronym / sponsor ID
- 19_20_029
- Conditions
- Wellbeing
- Keywords
- Emergency services, wellbeing, stress, physiological responses, subjective mediators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 11 Feb 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.
Emergency Service teams operate in some of the most challenging workplaces and experience higher rates of mental ill health than the general population. Effective interventions are required to enhance wellbeing, but as a first step it is crucial to understand the context through which to develop these initiatives. This preliminary study will test the feasibility of implementing a larger study to map the relationship between physical responses associated with levels of stress (heart rate variability) and personal, social and organisational factors that mediate these responses. In doing so, it is hoped to provide an insight into factors that shape emergency staff members' response to stress to help develop and personalise wellbeing initiatives.
Detailed description
The study team is proposing a large study in the Essex Emergency Services to map the relationship between physiological indicators of stress and subjective mediators and, in doing, provide insight into factors that shape a staff members' response to stress, which could help to develop and personalise wellbeing initiatives.
However, before undertaking a large study it is proposed to establish operational feasibility. This feasibility study will enrol ten shift-working staff from each of three emergency services (Essex Police, Essex County Fire and Rescue Service and East of England Ambulance Service Trust). Over a 3-day period, we will evaluate participants' physiological response to stressors by measuring HRV (using Firstbeat Bodyguard 2 beat-to-beat heart rate monitor). During the same period, participants will keep a personal online journal of events during the day. As part of the lifestyle assessment, data from the heart rate monitor and journal will be analysed and participants will receive a Summary Report including information on their body's reaction to stress and how this may be managed. Following the lifestyle assessment, the research team will facilitate semi-structured interviews; they will use participants' lifestyle assessment Summary Reports to inform appropriate questions. The team will discuss subjective experiences with participants as well as their overall experience with the data collection process.
The objectives of the feasibility study are to:
- Evaluate feasibility of undertaking a larger definitive study in terms of:
- Willingness and eligibility of emergency services' staff to take part in the study
- Recruitment timeframe
- Participant adherence to lifestyle assessment protocols (including wearing a heart rate monitor and completing an online journal over a 3-day period)
- Proportion of participants in whom an interview is arranged and completed
- Feasibility of other operational aspects not included above.
- Undertake an initial evaluation of physiological indicators and subjective mediators of stress and identify any i) associations between them and ii) patterns that emerge between individual participants.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency services staff | – | Other: This is an observational study, there are no interventionsEmergency Services staff recruited from the Ambulance, Police, and Fire and Rescue Services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A purposive, non-probability sample will be selected and recruited comprising ten operational shift working staff from each of three emergency services (Essex Police, Essex County Fire and Rescue Service and East of England Ambulance Trust).
Key inclusion criteria (4 listed)
- are aged 18 or older
- full-time employees
- work shift patterns and will be on-duty during the study period
- are able to take part in and contribute to the study (see exclusion criteria below).
Key exclusion criteria (6 listed)
- off-duty or on leave during the study period
- part-time (or on-call) employees
- not working shift patterns
- currently taking part in research that may impact on results, design or scientific value of this study (or other studies)
- not able to read or understand the English Language as it will not be possible to provide translation services for the study
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 |
|---|---|---|
| This is an observational study, there are no interventionsThis is an observational study, there are no interventions | Other | Emergency services staff |
Primary outcome
Feasibility of study recruitment - the number of staff volunteering to take part
Time frame: From the start to the end of recruitment at each participating site, approximately 4 weeks
The number of staff volunteering to take part
Feasibility of study recruitment - the proportion of staff targeted through study advertising who volunteer to take part
Time frame: From the start to the end of recruitment at each participating site, approximately 4 weeks
The proportion of staff estimated to have been targeted through study advertising who volunteer to take part
Feasibility of study recruitment - the proportion of staff volunteering to take part in the study who are eligible
Time frame: From the start to the end of recruitment at each participating site, approximately 4 weeks
The proportion of staff volunteering to take part in the study who are eligible
Adherence to heart rate monitoring during 3-day lifestyle assessment
Time frame: At Day 3 of the lifestyle assessment
The proportion of time the heart rate monitor was worn by participants measured using data collected by the monitor
Adherence to completion of online journal during 3-day lifestyle assessment
Time frame: At Day 3 of the lifestyle assessment
The proportion of participants completing the journal
Feasibility of conducting interviews
Time frame: On completion of interviews i.e. at approximately 8 weeks
The proportion of participants in whom an interview is arranged and completed
2 secondary outcomes
Heart rate variance
Time frame: Measured during lifestyle assessment over a period of 3 days - at approximately 3 weeks post-recruitment
Subjective mediators of stress
Time frame: On completion of interviews i.e. at approximately 8 weeks
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 9 Feb 2022.
- 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.
Enrico Dippenaar principal investigator
Anglia Ruskin University
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 Wellbeing, run by Anglia Ruskin University 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 4 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: finished, as of the sponsor's last update on 9 Feb 2022. 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?
Feasibility of study recruitment - the number of staff volunteering to take part (time frame: From the start to the end of recruitment at each participating site, approximately 4 weeks). The study lists 6 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 9 Feb 2022; AzTrials last refreshed its copy on 27 Oct 2026.