A Tool of the Future for Strengthening Compassion in a Danish Hospital Setting.

NCT07568977 | Recruiting

• 1 other identifier: CompassionHGH-01
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Focus of the Study is Measure Compassion Competence, Compassion Ability, Compassionate Care and Burnout; Compassion; Burnout

Keywords

Sinclair Compassion Questionnaire (SCQ); Validation; Compassion ability for healthcare providers; Compassion competence for healthcare providers; Compassionate care for patients; burnout in healthcare providers

Outcome Measures

Primary Outcomes (1)

• Sinclair Compassion Scale (SCQ)

  An overall score is obtained by summing all individual items and calculating a single mean score, in which a higher final score is indicative of a greater experience of compassion.

  September 1st 2025 - July 31st 2027

Study Arms (1)

Department cohorts

Cohort 1 with 5 subgroups 1. Department of Anaesthesia, operation and intensive care 2. Department of Nephrology 3. Department of Internal Medicine 4. Emergency Department 5. Department of Orthopedic Surgery

Other: Sinclair Compassion Scale

Interventions

Sinclair Compassion Scale OTHER

Patients are given the SCQ, healthcare providers are given the SCQ-ability and the SCQ-competence and the CBI

Department cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and healthcare professionals in 5 different departments at Herlev Gentofte Hospital

You may qualify if:

• 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
• Age 18-100+
• All genders
• Danish speaking
• Must have had contact with at least one healthcare professional before completing the questionnaire.

You may not qualify if:

• Age 0-17
• Non-Danish speaking
• 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. Perioperative and Intensive Care Department
• No contact with a healthcare professional
• Has answered the questionnaire before

Sponsors & Collaborators

• University of Copenhagen: collaborator
• University of Calgary: collaborator
• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev Gentofte Hospital

Herlev, 2630, Denmark

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Camilla B Sorensen, MD

  Herlev Gentofte Hospital

  PRINCIPAL INVESTIGATOR

• Nanja H Hansen, Psychologist

  Herlev Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla B. Sørensen, MD

CONTACT

+45 21 35 77 43; camilla.birgitte.sorensen@regionh.dk

Nanja H. Hansen, Psychologist

CONTACT

+45 21 35 77 43; nanja.holland.hansen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 6, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)