Measuring stress among intensive care unit healthcare workers
| ISRCTN | ISRCTN85176539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85176539 |
| IRAS number | 309034 |
| Secondary identifying numbers | 21HL18, IRAS 309034, CPMS 53690 |
- Submission date
- 16/08/2022
- Registration date
- 28/09/2022
- Last edited
- 07/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Challenging situations in the intensive care units (ICU) due to a high number of medical complications and/or deaths alongside prolonged working hours can lead to excessive stress among healthcare workers in these units. This can easily lead to burnout of the ICU healthcare worker. Current research shows that a large proportion of ICU workers are affected by stress and burnout across the globe. However, almost all of these studies are based on some form of survey questionnaires. There is no study to date to our knowledge attempting to physically measure stress and its effects on the body of ICU healthcare workers. The aim of this study is to investigate the use of various markers related to external (or physical) load, internal (or physiological) load, and sleep in measuring stress among healthcare staff working in the ICU.
Who can participate?
NHS health care staff (doctors or nursing colleagues) working in the paediatric ICU for at least 2 months
What does the study involve?
The study involves monitoring physiological variables using wearable, lightweight, waterproof devices for a continuous period of 7 days with participants performing a cluster of ICU shift work in between this time period. Devices include a sleep recording wristwatch and an ECG (electrocardiogram: measuring electrical signals of the heart) recorder applied to the participant's chest wall. Data about their physical activity, heart rate changes, and sleep will be recorded for a continuous period of 7 days. The recording period will involve 2-3 day or night shifts working in the ICU. The participants will also be asked to complete a sleep diary daily and an online anonymised questionnaire about the ease of use of the devices at work and home environment. No follow-up of the participants is required.
What are the possible benefits and risks of participating?
Taking part in this study will not benefit the participant directly. The information collected will show whether the proposed markers for measuring stress and its effect on healthcare workers are good enough to be used for this purpose in an even bigger study. If proven successful, these markers may be used routinely in the future to monitor stress and study the effects of interventions to reduce stress levels on an individual basis. The researchers do not expect any significant risks to the participants as a result of taking part in this study.
Where is the study run from?
Great Ormond Street Hospital for Children NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2021 to December 2024
Who is funding the study?
Paediatric Critical Care Society (UK)
Who is the main contact?
Dr Rohit Saxena, Rohit.saxena@gosh.nhs.uk
Contact information
Principal Investigator
Great Ormond Street Hospital for Children NHS Trust
Flamingo Ward (CICU)
Great Ormond Street
London
WC1N 3JH
United Kingdom
 ORCID ID |
0000-0002-1731-401X |
|---|---|
| Phone | +44 (0)2074059200 |
| rohit.saxena@gosh.nhs.uk |
Study information
| Study design | Prospective non-randomized cohort proof of concept two-centre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Quantitative assessment of stress among intensive care unit workforce - a proof of concept study |
| Study acronym | MESSI |
| Study objectives | Proposed metrics related to external (physical) load, internal (physiological) load and sleep are useful in quantifying stress among healthcare staff working in the intensive care setting. |
| Ethics approval(s) | Not required as the study is on NHS staff. |
| Health condition(s) or problem(s) studied | Stress among healthcare workers in intensive care unit |
| Intervention | The study involves monitoring physiological variables (physical activity, heart rate variation and sleep parameters) using wearable, lightweight, waterproof devices for a continuous period of 7 days with participants performing a cluster of ICU shift work in between this time period. Devices include a sleep recording wristwatch and an ECG (electrocardiogram: measuring electrical signals of the heart) recorder applied to the participant's chest wall. Data about their physical activity, heart rate changes, and sleep will be recorded for a continuous period of 7 days. The recording period will involve 2-3 day or night shifts working in the ICU. The participants will also be asked to complete a sleep diary daily and an online anonymised questionnaire about the ease of use of the devices at work and home environment. No follow-up of the participants is required. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MotionWatch 8, Actiheart5 |
| Primary outcome measure | Measured continuously over a period of 7 days using MotionWatch 8 and Actiheart5 devices: 1. Heart rate variability 2. Sleep parameters: sleep latency, sleep duration, sleep efficiency and wakefulness after sleep onset These outcome measures will be monitored for a total of 7 days (at home and work environment) with participants performing a cluster of ICU shift work in between this time period. |
| Secondary outcome measures | Ease of use of the monitors measured using an anonymised online questionnaire at the end of the measurement period of 7 days |
| Overall study start date | 01/02/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Informed consent to participate 2. Medical or nursing NHS healthcare staff working in the ICU for at least 2 months |
| Key exclusion criteria | 1. Known to have significant arrhythmia or on antiarrhythmic medications 2. Active pharmacological or psychological therapy for stress |
| Date of first enrolment | 09/01/2023 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
WC1N 3JH
United Kingdom
London
W2 1NY
United Kingdom
Sponsor information
Hospital/treatment centre
Great Ormond Street
London
WC1N 3JH
England
United Kingdom
| Phone | +44 (0)2079052669 |
|---|---|
| research.governance@gosh.nhs.uk | |
| Website | http://www.gosh.nhs.uk/ |
"ROR" |
https://ror.org/03zydm450 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a subject relevant peer reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
07/09/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 15/09/2023 to 30/11/2024.
2. The overall study end date was changed from 16/11/2023 to 31/12/2024.
3. The intention to publish date was changed from 01/03/2024 to 31/03/2025.
14/10/2022: The recruitment start date was changed from 15/11/2022 to 09/01/2023.
03/10/2022: Internal review.
17/08/2022: Trial's existence confirmed by the Paediatric Critical Care Society, UK.
