Trial reportArtificial organs2025
Addressing Disturbance in Bodily Experience After Ventricular Assist Device Implantation: A Multicenter Randomized Controlled Trial of Curricular Psychological Support.
Trial report in Artificial organs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDisturbance in bodily experience (BE) after ventricular assist device (VAD) implantation is common. This study aims to investigate the effect of focused psychological support to improve BE in VAD patients.
methodsThis national, multicenter, longitudinal study enrolled 140 VAD patients from four centers across Germany in a prospective, randomized controlled trial. Patients were randomized (1:1) to receive curricular and focused psychological intervention in the post-implantation step-down units after implantation (n = 70) or treatment as usual (n = 70). BE was assessed using the Bodily Experience Scale in VAD Patients (BE-S) after implantation (baseline) and followed up 12 months later. Data were analyzed using mixed-effects models.
resultsVAD patients with disturbance in BE (BE-S ≥ 2) after implantation (n = 43, 63.24%) benefit from the targeted intervention. Compared to the subsample of the control group (CG) patients with initial BE disturbance (n = 46, 69.7%), the intervention group (IG) displays a significantly stronger decrease from baseline to the 1-year follow-up (p = 0.01). Generally, women (p = 0.4) and emergently implanted patients (p = 0.24) show a smaller, albeit not significant, decrease in BE disturbance. All patients have high overall gratitude scores, which increase slightly but not significantly over time.
conclusionThe efficacy of targeted psychological support in reducing disturbance in BE among VAD patients is highlighted. Given the strong correlation between BE and other mental health domains, such as anxiety and depression, it is essential to address disturbances in BE to improve the overall mental health of VAD patients.
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