NCT07450339

Brief 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. 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
Last Updated

March 4, 2026

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

February 19, 2026

Last Update Submit

February 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    from enrollment to the end of treatment at 18 months

Secondary Outcomes (3)

  • Change in score on the professional burnout subscale

    from the enrollment to the end of treatment at 18 months

  • Change in the Secondary Traumatic Stress sub scale score

    from the enrollment to the end of treatment at 18 months

  • Association between participants' characteristics and level of participation with changes in scale scores

    From the enrollment to the end of treatment at 18 months

Study Arms (1)

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.

Other: Focus Group

Interventions

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

16groups composed of different healthcare professionals from the Emergency Department and ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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;

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Compassion FatigueBurnout, Psychological

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, Psychological

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 4, 2026

Study Start

April 3, 2023

Primary Completion

February 10, 2025

Study Completion

February 10, 2025

Last Updated

March 4, 2026

Record last verified: 2025-08

Locations