Serious Game-Based Training for Withholding and Withdrawing Life-Sustaining Treatments in the ICU

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The HUGS study ("Helpful Use of serious Game in life‐Sustaining withdrawal") is aprospective, multicenter, randomized controlled, single‐blind study evaluating the impactof a serious game on medical students' knowledge and skills regarding Withholding andwithdrawing life‐sustaining treatments (WWLST) in ICU WWLST are frequent in ICU and raiseimportant ethical, legal, and communication issues. In France, these decisions aregoverned by the Claeys‐Leonetti law, which emphasizes respect for patients' wishes,avoidance of unreasonable treatment, collegial decision‐making, consultation with anexternal physician, and documentation. Despite their importance, specific training onWWLST remains limited.The study will compare two educational approaches: a 25‐minute serious game (SG) and a25‐minute narrated PowerPoint lecture (PPL). The serious game was developed to strengthenknowledge of the decision‐making process, ethical considerations, and communication withhealthcare teams and patients' relatives.The primary objective is to assess the impact of the serious game on students'competencies, measured by an Objective Structured Clinical Examination (OSCE) on WWLST inICU. Secondary outcomes include a multiple‐choice 10 questions (MCQ) and two ScriptConcordance Tests (SCTs) immediately after training, satisfaction with the educationalmethod, and self‐assessment of competence following the OSCE.Participants will be medical students in years DFASM1‐3 undertaking internships inanesthesia and intensive care departments of the PARABOL university medical group.Eligible participants must be aged 18 or older. Students who have previously completedthe serious game or the control training will be excluded.A total of 164 students (82 per group) will be recruited across four centers:Bichat‐Claude Bernard, Lariboisière, Saint‐Louis, and Beaujon hospitals. The inclusionperiod will last 12 months. Using a previously published distribution of OSCE scoresamong medical students (standard deviation = 5 points), and assuming 90% power with atwo‐sided type I error of 5%, the required sample size was calculated to be 164participants (82 per group).
Epistemonikos ID: 5d12d84601647f6c42028a0e907044e9ed0e3bc2
First added on: Sep 11, 2026