N18.5 Z99.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Chronic hemodialysis requirement for at least 3 months Regular hemodialysis treatment (at least 2×/week) at Robert Bosch Hospital Stuttgart Sufficient German language skills to participate in interviews and complete questionnaires Written informed consent after comprehensive patient information
Exclusion criteria
Exclusion criteria: Severe cognitive impairment that makes study participation impossible Severe visual impairment that makes performing visual artistic activities impossible Acute severe psychiatric disorders (active psychosis, severe mania) Lack of capacity to consent Expected kidney transplantation or change of dialysis center within the next 3 months Participation in another interventional study with psychological well-being or quality of life as primary endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in disease-specific quality of life measured with the Kidney Disease Quality of Life Instrument (KDQOL) German version Assessment timepoints: T0 (Baseline): 1-2 weeks before intervention start T12 (End of intervention): After 12 weeks (directly after last art therapy session) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychological Parameters: Stress: Perceived Stress Scale (PSS-10) - Assessment at baseline (T0) and week 12 (T12) Anxiety: Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) - Assessment at T0 and T12 Subjective well-being during dialysis: Visual Analogue Scale (VAS, 0-10) - Assessment at T0 and weekly after each art therapy session (T1-T12) 2. Clinical Parameters: Interdialytic weight gain: Difference between dry weight and pre-dialysis weight (kg) - Retrospective data 4 weeks before intervention and continuous documentation during 12-week intervention period Blood pressure during dialysis: Mean systolic blood pressure values - Retrospective data before intervention and prospective documentation during each session (T1-T12) Premature therapy discontinuation: Number and reasons - Continuous documentation throughout intervention period (weeks 1-12) Cortisol levels: Saliva samples collected before and after art therapy sessions at weeks 4, 8, and 12, with baseline measurement at T0 3. Therapeutic Adherence: Participation rate: Number of attended sessions divided by number of planned sessions - Continuous documentation, evaluated at T12 Engagement: Therapist rating of patient engagement using a 5-point Likert scale - Assessment after each session (T1-T12) 4. Qualitative Outcomes: Patient perspective: Semi-structured interviews exploring subjective experience of the intervention, perceived changes in coping with dialysis treatment, impact on daily life and disease management, and feedback for improvement - Assessment at T12 Staff perspective: Semi-structured interviews examining observed changes in participating patients, impact on workflow and care quality, acceptance and integration of intervention into clinical routine, and recommendations for future implementation - Assessment at T12 Art therapy process analysis: Documentation of artistic expression development, thematic content of artworks, therapeutic relationship dynamics, | — |
Countries
Germany
Contacts
Robert Bosch Krankenhaus