StressRESISTNCT06818539
Burnout and Resilience in Hospital-based Nursing and Medical Personnel and Trainees
An observational study of Stress and Burnout, run by University of Limerick at 1 site in Ireland.
Trial summary
Aims to look at associations between work stress, burnout and resilience in hospital-based nurses and medical professionals in several EU countries. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- How many people
- 650 participants
- Where
- 1 siteIreland
- Study dates
- 1 Feb 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital-based doctors and nurses across the European Union
Who may be able to join
- Hospital-based nurses and doctors
Who cannot join
- Non-hospital based healthcare professionals, under 18 and over 66, non-medical hospital staff
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trina Tamrakar, PhD contact
Ireland1 site
Department of Psychology
Limerick, V94 XD21
Stephen Gallagher, PhD, +35361234899 ext. 4899, Stephen.Gallagher@ul.ie
Trina Tamrakar, PhD, Trina.Tamrakar@ul.ie
About this study
Official title: Burnout in Hospital-based Nursing and Medical Personnel and Trainees: A Mixed Methods Approach
Aims to look at associations between work stress, burnout and resilience in hospital-based nurses and medical professionals in several EU countries.
Read the detailed description
Healthcare professionals, in particular, hospital-based nursing and medical staff, especially surgical specialities, are experiencing symptoms of burnout as never before. Within healthcare, job commitment is at stake leading to staff shortages which places further stress on the health care system, creating a vicious cycle of stressful work environment.
This is the context of the present study, and our aim is to explore quantitatively how factors like resilience, work-setting factors like job support, autonomy and leadership contribute to burnout in hospital-based nursing and medical personnel. These factors have been found to be predictive of burnout with few studies looking at synergistic interactions between these predictors. A survey design will be used for quantitative data collection. This study will also include qualitative interview-based study to complement the quantitative study.
- Keywords
- stress, burnout, resilience, crosssectional, healthcare workers, nurses, doctors, surgeons, observational, healthcare professionals, work stress
- Medical subject headings
- Burnout, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Doctors and nurses | Hospital-based doctors and nurses, surgical as well as non-surgical pathways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience scores among hospital-based doctors and nurses
Resilience will be measured with Short Resilience Survey (SRS), an 8-item short resilience scale developed for healthcare workers. This measure consists of two subscales, Activation and Decompression. An examples of Decompression items include "can enjoy my personal time without focusing on work matters" and Activation "I care for all patients/clients equally even when it is difficult." These measures exist independent of employee engagement, indicating an empirical distinction between the two concepts. Response categories on the items (with 1 =Strongly Disagree to 5 = Strongly Agree), with higher scores indicating better Activation and Decompression ability.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Cross-sectional
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Copenhagen University Hospital, Rigshospitalet, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Stephen Gallagher, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818539
- Sponsor's protocol ID
- EHSREC2024_06_02
- Other IDs
- KEEPCARING #101137244
- Acronym
- RESIST
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an anonymised data without participant identifiers, and investigating aggregate data and not individual participant data.
Publications
Greville-Harris M, Withers C, Wezyk A, Thomas K, Bolderston H, Kane A, McDougall S, Turner KJ. Association of resilience and psychological flexibility with surgeons' mental wellbeing. BJS Open. 2024 Jul 2;8(4):zrae060. doi: 10.1093/bjsopen/zrae060.
PubMed 39041733Cha YJ, Lee KS, Cho JH, Choi IS, Lee D. Effect of Job Stress on Burnout among Nurses Responding to COVID-19: The Mediating Effect of Resilience. Int J Environ Res Public Health. 2022 Apr 29;19(9):5409. doi: 10.3390/ijerph19095409.
PubMed 35564803Morgan KH, Libby NE, Weaver AK, Cai C. Development of an early warning resilience survey for healthcare organizations. Heliyon. 2019 Nov 1;5(10):e02670. doi: 10.1016/j.heliyon.2019.e02670. eCollection 2019 Oct.
PubMed 31720458
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burnout in Hospital-based Nursing and Medical Personnel and Trainees: A Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT06818539
- Acronym / sponsor ID
- RESIST / EHSREC2024_06_02
- Keywords
- stress, burnout, resilience, crosssectional, healthcare workers, nurses, doctors, surgeons
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Copenhagen University Hospital, Rigshospitalet, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 10 Feb 2025 (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.
Aims to look at associations between work stress, burnout and resilience in hospital-based nurses and medical professionals in several EU countries.
Detailed description
Healthcare professionals, in particular, hospital-based nursing and medical staff, especially surgical specialities, are experiencing symptoms of burnout as never before. Within healthcare, job commitment is at stake leading to staff shortages which places further stress on the health care system, creating a vicious cycle of stressful work environment.
This is the context of the present study, and our aim is to explore quantitatively how factors like resilience, work-setting factors like job support, autonomy and leadership contribute to burnout in hospital-based nursing and medical personnel. These factors have been found to be predictive of burnout with few studies looking at synergistic interactions between these predictors. A survey design will be used for quantitative data collection. This study will also include qualitative interview-based study to complement the quantitative study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doctors and nurses | – | –Hospital-based doctors and nurses, surgical as well as non-surgical pathways |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital-based doctors and nurses across the European Union
Key inclusion criteria (1 listed)
- Hospital-based nurses and doctors
Key exclusion criteria (1 listed)
- Non-hospital based healthcare professionals, under 18 and over 66, non-medical hospital staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resilience scores among hospital-based doctors and nurses
Time frame: 5 months
Resilience will be measured with Short Resilience Survey (SRS), an 8-item short resilience scale developed for healthcare workers. This measure consists of two subscales, Activation and Decompression. An examples of Decompression items include "can enjoy my personal time without focusing on work matters" and Activation "I care for all patients/clients equally even when it is difficult." These measures exist independent of employee engagement, indicating an empirical distinction between the two concepts. Response categories on the items (with 1 =Strongly Disagree to 5 = Strongly Agree), with higher scores indicating better Activation and Decompression ability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 39041733Greville-Harris M, Withers C, Wezyk A, Thomas K, Bolderston H, Kane A, McDougall S, Turner KJ. Association of resilience and psychological flexibility with surgeons' mental wellbeing. BJS Open. 2024 Jul 2;8(4):zrae060. doi: 10.1093/bjsopen/zrae060.
- Background: PubMed 35564803Cha YJ, Lee KS, Cho JH, Choi IS, Lee D. Effect of Job Stress on Burnout among Nurses Responding to COVID-19: The Mediating Effect of Resilience. Int J Environ Res Public Health. 2022 Apr 29;19(9):5409. doi: 10.3390/ijerph19095409.
- Background: PubMed 31720458Morgan KH, Libby NE, Weaver AK, Cai C. Development of an early warning resilience survey for healthcare organizations. Heliyon. 2019 Nov 1;5(10):e02670. doi: 10.1016/j.heliyon.2019.e02670. eCollection 2019 Oct.
- This study is part of a larger EU-funded project called KEEPCARING: Future Proofing Health- and Care Systems Safeguarding Healthcare Workers in Hospital Settings.Link provided by the sponsor.
- Individual participant dataSharing planned: No. This is an anonymised data without participant identifiers, and investigating aggregate data and not individual participant data.
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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.
Trina Tamrakar, PhD contact
Stephen Gallagher, PhD principal investigator
University of Limerick
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 Stress and Burnout, run by University of Limerick at 1 site in Ireland.
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: opening soon, as of the sponsor's last update on 10 Feb 2025. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Gallagher, PhD (+35361234899 ext. 4899, Stephen.Gallagher@ul.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience scores among hospital-based doctors and nurses (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06818539, which also lists 3 linked publications.
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 10 Feb 2025.