A Tool of the Future for Strengthening Compassion in a Danish Hospital Setting.
Recruiting
Observational Study
BurnoutCompassion AbilityCompassion CompetenceCompassionate CareInvestigate Compassionate Care and Burnout in Healthcare
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
2,200 (estimated)
Sponsor
Herlev and Gentofte Hospital · Other
Who this trial is looking for
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This study is a multi-phase, mixed-methods clinical investigation designed to examine the feasibility, validity, and organizational applicability of a structured measurement framework for assessing compassion in a Danish hospital setting. The study is conducted at Herlev and Gentofte Hospital and involves both patients and healthcare professionals across multiple clinical departments.
The study i…
This study is a multi-phase, mixed-methods clinical investigation designed to examine the feasibility, validity, and organizational applicability of a structured measurement framework for assessing compassion in a Danish hospital setting. The study is conducted at Herlev and Gentofte Hospital and involves both patients and healthcare professionals across multiple clinical departments.
The study is structured in three sequential phases, each addressing distinct methodological and implementation components.
Phase 1 (Translation and Cultural Adaptation):
The initial phase involves the linguistic translation and cultural adaptation of three versions of the Sinclair Compassion Questionnaire (SCQ) and associated healthcare professional measures. This process follows established international guidelines for cross-cultural validation, including forward translation, back-translation, expert panel review, and pilot testing. Cognitive interviewing techniques are used to evaluate comprehension, relevance, and cultural appropriateness among both patients and healthcare professionals. Particular attention is given to semantic equivalence and the contextual meaning of key constructs across languages and professional groups.
Phase 1b (Psychometric Validation):
Following adaptation, the instruments are administered to a patient sample recruited from departments of anesthesia, surgery, and intensive care. Data collected in this phase are used to assess the psychometric properties of the translated instruments, including internal consistency, construct validity, factor structure, and measurement invariance. Statistical analyses include confirmatory factor analysis and reliability testing. The aim of this phase is to ensure that the instruments demonstrate robust measurement properties within the Danish healthcare context.
Phase 2 (Observational Implementation Study):
In the second phase, the validated instruments are implemented across four hospital departments, including medical, nephrology, orthopedic surgery, and emergency care. Data are collected from both patients and healthcare professionals to allow for multi-perspective analysis. In addition to questionnaire data, contextual variables such as demographic characteristics, professional background, and organizational factors are recorded. Administrative data, including sick leave and workforce indicators, are incorporated where available.
This phase employs a cross-sectional observational design with embedded comparative analyses across departments and professional groups. Multilevel modeling approaches are used to account for clustering within departments and to explore variation at individual and organizational levels. The design enables identification of patterns and differences across settings without introducing experimental manipulation.
Phase 3 (Contextualized Implementation and Development):
The third phase involves the application of findings from earlier phases to inform targeted implementation strategies. Rather than introducing a predefined intervention, this phase adopts an adaptive approach in which context-specific initiatives are selected or developed based on identified needs. This may include integration of existing training programs, workflow adjustments, or development of new tools. The implementation process is supported by interdisciplinary collaboration, including expertise in clinical practice, education, and organizational development.
Data Collection and Management:
Data are collected using secure electronic platforms compliant with Danish data protection regulations. All participant data are handled in accordance with GDPR requirements. Identifiable data are stored separately from research data, and access is restricted to authorized personnel. Data quality assurance procedures include validation checks and standardized data entry protocols.
Participant Involvement:
Patients are recruited during their contact with hospital departments and provide self-reported data through questionnaires. Healthcare professionals participate by completing self-assessment measures. Participation is voluntary, and no experimental interventions are administered.
Statistical Considerations:
The study uses both descriptive and inferential statistical methods. Psychometric analyses are conducted in Phase 1b, while Phase 2 includes regression analyses and multilevel modeling to examine associations between variables. Missing data are handled using appropriate statistical techniques, such as multiple imputation where relevant.
Ethical Considerations:
The study adheres to ethical guidelines for clinical research involving human participants. Informed consent is obtained from all participants. Participation does not influence clinical care or employment conditions. The study design minimizes participant burden by integrating data collection into existing clinical workflows where possible.
Trial Locations
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Eligibility Criteria
Patients:
Inclusion Criteria:
1. A patient at either the a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department (ED) d. Department of Orthopedic Surgery.Rheumatology and Orthopedics or e. Perioperative and Intensive Care Department
2. Age 18-100+
3. All genders
4.…
Patients:
Inclusion Criteria:
1. A patient at either the a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department (ED) d. Department of Orthopedic Surgery.Rheumatology and Orthopedics or e. Perioperative and Intensive Care Department
2. Age 18-100+
3. All genders
4. Danish speaking
5. Must have had contact with at least one healthcare professional before completing the questionnaire.
Exclusion Criteria:
1. Patient exclusion criteria:
2. Age 0-17
3. Non-Danish speaking
4. Not a patient at the a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department (ED) d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care)
5. No contact with a healthcare professional
6. Has answered the questionnaire before
Healthcare professionals:
HCP inclusion criteria
1. Employed in one of the five departments included (phase 1b and 2): a. Department of Nephrology, b. Department of Internal Medicine c. Emergency Department, d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care.
2. All genders
3. Danish speaking
4. Must have engaged with a patient
HCP exclusion criteria
1. Not employed in one of the five departments included (a. Department of Nephrology, b. Department of Internal Medicine, c. Emergency Department, d. Department of Orthopedic Surgery or e. Department of Anesthesia, Operation and Intensive Care)
2. Not Danish speaking
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