Compassion FatigueEMERGENCYNCT07450339
Compassion Fatigue in Healthcare Workers Working in the Emergency Department, Emergency Room, and General Intensive Care Units.
An observational study of Compassion Fatigue and Burnout, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Compassion Fatigue can be conceptualized as consisting of two components (Gentry, 2015): (1) burnout, and (2) secondary traumatic stress (STS), also referred to as vicarious trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compassion Fatigue, Burnout, Stress (Psychology)
- What is being tested?
- Focus Group
- How many people
- 159 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2023to 10 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of healthcare professionals working in the Emergency Department and Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo in Pavia, including attending physicians, medical residents, nurses, and healthcare assistants.
Who may be able to join
- Minimum age of 18 years at the time of questionnaire completion;
- Employment in the Emergency Room or General Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo as a physician, nurse, or healthcare assistant at the time of questionnaire completion;
- Provision of written informed consent. Exclusion Criteria
- Individuals who, although employed at the Policlinico San Matteo at the time of questionnaire completion, do not work as physicians, nurses, or healthcare assistants or do not reside in Italy at the time of questionnaire completion;
- Individuals who, although employed at the Policlinico San Matteo at the time of questionnaire completion and working as physicians, nurses, or healthcare assistants, are not assigned to one of the departments involved in the study (Emergency Room or General Intensive Care Unit).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compassion Fatigue in Healthcare Workers Working in the Emergency Department, Emergency Room, and General Intensive Care Units. A PRE-POST Participatory Action Research Study
Compassion Fatigue can be conceptualized as consisting of two components (Gentry, 2015): (1) burnout, and (2) secondary traumatic stress (STS), also referred to as vicarious trauma.
The study includes a quantitative assessment through the administration of the Professional Quality of Life Scale (Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5; Stamm, 2009) at two time points, baseline (T0) and follow-up (T1), to measure levels of Compassion Fatigue among healthcare professionals working within the Emergency Department, specifically in the Emergency Room and General Intensive Care Unit.
Read more
In the interval between the two quantitative assessments, following T0 and preceding T1, a Participatory Action Research (PAR) approach will be conducted. The study will also explore potential protective and risk factors related to Compassion Fatigue specific to the Emergency Room and General Intensive Care Unit settings. The Participatory Action Research will be carried out using focus group methodology.
The primary objective of the study is to assess Compassion Fatigue (Larsen \& Stamm, 2008) among healthcare professionals working in the Emergency Department, specifically in the Emergency Room and General Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo in Pavia, before (T0) and after (T1) the implementation of the Participatory Action Research conducted through focus groups. The second assessment (T1) will be carried out 18 months after the baseline assessment (T0)
- Conditions
- Compassion Fatigue, Burnout, Stress (Psychology), Coping
- Being tested
- Focus Group
- Medical subject headings
- Compassion Fatigue, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
The focus groups were organized into five modules: (1) compassion fatigue, burnout, and secondary traumatic stress; (2) coping strategies (problem-focused and emotion-focused coping); (3) work motivation and work-related stress; (4) work-life balance; and (5) advice and work organization
| Study group | Role | What they receive |
|---|---|---|
| 16groups composed of different healthcare professionals from the Emergency Department and ICU | Participants were stratified according to clinical department (Emergency Department and Intensive Care Unit) and professional role (physician, medical residents, nurses, and healthcare assistants), resulting in a total of 16 groups. Each group was invited to participate in a series of focus groups aimed at exploring topics such as burnout, secondary traumatic stress, coping strategies, and related psychological experiences. Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the change in the Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5 (Stamm, 2009) score measured before (T0) and after (T1) the focus group sessions.
The primary objective will be measured using the following psychological instrument: the Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5 (ProQOL; Stamm, 2009), a self-report questionnaire consisting of 20 items designed to assess Compassion Fatigue in caregiving activities.
The primary endpoint will be the difference between the Professional Quality of Life scores measured at the 18-month follow-up (T1) after the Participatory Action Research (focus groups) and the baseline assessment (T0), both overall and stratified by clinical department.
Measured: from enrollment to the end of treatment at 18 months
Secondary outcomes (3)
Change in score on the professional burnout subscale
The Student's t-test (or its non-parametric equivalent, the Wilcoxon signed-rank test) will be used for paired data to compare the score on the professional burnout scale recorded at T1 with that recorded at T0. The analyses will be repeated for each UOC.
Measured: from the enrollment to the end of treatment at 18 months
Change in the Secondary Traumatic Stress sub scale score
Change in the Secondary Traumatic Stress sub scale score:
The higher the score, the higher the level of secondary traumatization.
Measured: from the enrollment to the end of treatment at 18 months
Association between participants' characteristics and level of participation with changes in scale scores
Association between participants' characteristics and level of participation with changes in scale scores
Measured: From the enrollment to the end of treatment at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start3 Apr 2023
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compassion FatigueStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Perlini, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450339
- Sponsor's protocol ID
- EMERGENCY FATIGUE
- Acronym
- EMERGENCY
- Status last verified
- Aug 2025
- First submitted
- 19 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassion Fatigue in Healthcare Workers Working in the Emergency Department, Emergency Room, and General Intensive Care Units. A PRE-POST Participatory Action Research Study
- ClinicalTrials.gov ID
- NCT07450339
- Acronym / sponsor ID
- EMERGENCY / EMERGENCY FATIGUE
- Conditions
- Compassion Fatigue, Burnout, Stress (Psychology), Coping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 4 Mar 2026 (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.
Compassion Fatigue can be conceptualized as consisting of two components (Gentry, 2015): (1) burnout, and (2) secondary traumatic stress (STS), also referred to as vicarious trauma.
The study includes a quantitative assessment through the administration of the Professional Quality of Life Scale (Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5; Stamm, 2009) at two time points, baseline (T0) and follow-up (T1), to measure levels of Compassion Fatigue among healthcare professionals working within the Emergency Department, specifically in the Emergency Room and General Intensive Care Unit.
In the interval between the two quantitative assessments, following T0 and preceding T1, a Participatory Action Research (PAR) approach will be conducted. The study will also explore potential protective and risk factors related to Compassion Fatigue specific to the Emergency Room and General Intensive Care Unit settings. The Participatory Action Research will be carried out using focus group methodology.
The primary objective of the study is to assess Compassion Fatigue (Larsen \& Stamm, 2008) among healthcare professionals working in the Emergency Department, specifically in the Emergency Room and General Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo in Pavia, before (T0) and after (T1) the implementation of the Participatory Action Research conducted through focus groups. The second assessment (T1) will be carried out 18 months after the baseline assessment (T0)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16groups composed of different healthcare professionals from the Emergency Department and ICU | – | Other: Focus GroupParticipants were stratified according to clinical department (Emergency Department and Intensive Care Unit) and professional role (physician, medical residents, nurses, and healthcare assistants), resulting in a total of 16 groups. Each group was invited to participate in a series of focus groups aimed at exploring topics such as burnout, secondary traumatic stress, coping strategies, and related psychological experiences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of healthcare professionals working in the Emergency Department and Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo in Pavia, including attending physicians, medical residents, nurses, and healthcare assistants.
Key inclusion criteria (5 listed)
- Minimum age of 18 years at the time of questionnaire completion;
- Employment in the Emergency Room or General Intensive Care Unit of the Fondazione IRCCS Policlinico San Matteo as a physician, nurse, or healthcare assistant at the time of questionnaire completion;
- Provision of written informed consent. Exclusion Criteria
- Individuals who, although employed at the Policlinico San Matteo at the time of questionnaire completion, do not work as physicians, nurses, or healthcare assistants or do not reside in Italy at the time of questionnaire completion;
- Individuals who, although employed at the Policlinico San Matteo at the time of questionnaire completion and working as physicians, nurses, or healthcare assistants, are not assigned to one of the departments involved in the study (Emergency Room or General Intensive Care Unit).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Focus GroupThe focus groups were organized into five modules: (1) compassion fatigue, burnout, and secondary traumatic stress; (2) coping strategies (problem-focused and emotion-focused coping); (3) work motivation and work-related stress; (4) work-life balance; and (5) advice and work organization | Other | 16groups composed of different healthcare professionals from the Emergency Department and ICU |
Primary outcome
The primary endpoint will be the change in the Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5 (Stamm, 2009) score measured before (T0) and after (T1) the focus group sessions.
Time frame: from enrollment to the end of treatment at 18 months
The primary objective will be measured using the following psychological instrument: the Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5 (ProQOL; Stamm, 2009), a self-report questionnaire consisting of 20 items designed to assess Compassion Fatigue in caregiving activities. The primary endpoint will be the difference between the Professional Quality of Life scores measured at the 18-month follow-up (T1) after the Participatory Action Research (focus groups) and the baseline assessment (T0), both overall and stratified by clinical department.
3 secondary outcomes
Change in score on the professional burnout subscale
Time frame: from the enrollment to the end of treatment at 18 months
Change in the Secondary Traumatic Stress sub scale score
Time frame: from the enrollment to the end of treatment at 18 months
Association between participants' characteristics and level of participation with changes in scale scores
Time frame: From the enrollment to the end of treatment at 18 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 4 Mar 2026.
Related trials for Compassion Fatigue
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Not yet recruiting
Mobile-Based Resilience Intervention for Moral Injury, Compassion Fatigue, and Distress in ICU Nurses
Moral Injury
Active, not recruiting
A Pilot Study of RISE for Nurse Managers Retreat
Burnout, Secondary Traumatic Stress
Not yet recruiting
Trauma-Informed Education and Self-Care for Social Work Students During Field Practicum
Secondary Traumatic Stress
Active, not recruiting
Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST)
Burnout, Burnout, Professional
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Compassion Fatigue and Burnout, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 5 inclusion and 0 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 4 Mar 2026. 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 Italy. 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?
The primary endpoint will be the change in the Professional Quality of Life: Compassion Satisfaction and Fatigue, Version 5 (Stamm, 2009) score measured before (T0) and after (T1) the focus group sessions. (time frame: from enrollment to the end of treatment at 18 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 4 Mar 2026.