Medical Students in Intensive Care UnitHUGSNCT07812727
Serious Game-Based Training for Withholding and Withdrawing Life-Sustaining Treatments in the ICU
A study testing serious game (SG) on WWLST and powerpoint lecture (PPL) on WWLST in people with Medical Students in Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Background: Withholding and withdrawing life-sustaining treatments (WWLST) are frequent in ICU and raise important ethical, legal, and communication issues. Despite their importance, specific training on WWLST remains limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Students in Intensive Care Unit
- What is being tested?
- serious game (SG) on WWLST and powerpoint lecture (PPL) on WWLST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- students from "Université Paris Cité" (UPC, Paris, France), completing internships in 5 ICU
Who cannot join
- prior participation in the WWLST serious game or previous exposure to the control training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serious Game-Based Training for Withholding and Withdrawing Life-Sustaining Treatments in the ICU: the HUGS Randomized Controlled Study
Background: Withholding and withdrawing life-sustaining treatments (WWLST) are frequent in ICU and raise important ethical, legal, and communication issues. Despite their importance, specific training on WWLST remains limited.
Study Objective: evaluating the impact of a serious game on medical students' knowledge and skills regarding WWLST in ICU Population: The study population consists of 164 medical students who are randomly assigned to two groups Study design: prospective, multicenter, randomized controlled, single-blind study. The study will compare two educational approaches: a 25-minute serious game (SG) and a 25-minute narrated PowerPoint lecture (PPL) Parameters: 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 in ICU. Secondary outcomes include a multiple-choice 10 questions (MCQ), two Script Concordance Tests (SCTs) immediately after training and satisfaction scales Hypothesis: A serious game-based training program on a highly complex topic such as WWLST in ICU could enable medical students to develop better skills and experience greater satisfaction compared to a conventional teaching method.
Read the detailed description
The HUGS study ("Helpful Use of serious Game in life-Sustaining withdrawal") is a prospective, multicenter, randomized controlled, single-blind study evaluating the impact of a serious game on medical students' knowledge and skills regarding Withholding and withdrawing life-sustaining treatments (WWLST) in ICU WWLST are frequent in ICU and raise important ethical, legal, and communication issues. In France, these decisions are governed by the Claeys-Leonetti law, which emphasizes respect for patients' wishes, avoidance of unreasonable treatment, collegial decision-making, consultation with an external physician, and documentation. Despite their importance, specific training on WWLST remains limited.
The study will compare two educational approaches: a 25-minute serious game (SG) and a 25-minute narrated PowerPoint lecture (PPL). The serious game was developed to strengthen knowledge of the decision-making process, ethical considerations, and communication with healthcare 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 in ICU. Secondary outcomes include a multiple-choice 10 questions (MCQ) and two Script Concordance Tests (SCTs) immediately after training, satisfaction with the educational method, and self-assessment of competence following the OSCE.
Participants will be medical students in years DFASM1-3 undertaking internships in anesthesia and intensive care departments of the PARABOL university medical group. Eligible participants must be aged 18 or older. Students who have previously completed the 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 inclusion period will last 12 months. Using a previously published distribution of OSCE scores among medical students (standard deviation = 5 points), and assuming 90% power with a two-sided type I error of 5%, the required sample size was calculated to be 164 participants (82 per group).
- Conditions
- Medical Students in Intensive Care Unit
- Being tested
- serious game (SG) on WWLST, powerpoint lecture (PPL) on WWLST
- Keywords
- life sustaining treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious game (SG) on WWLSTOther
serious game (SG) on WWLST
powerpoint lecture (PPL) on WWLSTOther
powerpoint lecture (PPL) on WWLST
| Study group | Role | What they receive |
|---|---|---|
| serious game (SG) on WWLST | Other | innovative, game-based teaching approach Receives: Other: serious game (SG) on WWLST |
| powerpoint lecture (PPL) on WWLST | Other | conventional teaching method Receives: Other: powerpoint lecture (PPL) on WWLST |
What is being measured
The primary outcome is the main question the study is designed to answer.
WWLST competencies in the ICU
Objective Structured Clinical Examination (OSCE) score (out of 17) assessing WWLST competencies in the ICU
Measured: end of the 3-month ICU internship
Secondary outcomes (6)
communication skills and attitudes
Score out of 5 on the OSCE "communication skills and attitudes" grid
Measured: end of the 3-month ICU internship
clinical aptitude
Score out of 12 on the OSCE "clinical aptitude" grid
Measured: end of the 3-month ICU internship
knowledge assessment
Score out of 10 on a multiple-choice question (MCQ) knowledge assessment
Measured: end of the 3-month ICU internship
Script Concordance Tests
Evaluation via two Script Concordance Tests (SCTs) on WWLST in the ICU
Measured: end of the 3-month ICU internship
satisfaction with the training modality
Assessment of participants' satisfaction with the training modality
Measured: end of the 3-month ICU internship
participants' perceived competence
Assessment of participants' perceived competence following the skills test
Measured: end of the 3-month ICU internship
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 May 2025
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Students in Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sebastien tanaka, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812727
- Sponsor's protocol ID
- Parabole2026
- Acronym
- HUGS
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Game-Based Training for Withholding and Withdrawing Life-Sustaining Treatments in the ICU: the HUGS Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07812727
- Acronym / sponsor ID
- HUGS / Parabole2026
- Conditions
- Medical Students in Intensive Care Unit
- Keywords
- life sustaining treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Withholding and withdrawing life-sustaining treatments (WWLST) are frequent in ICU and raise important ethical, legal, and communication issues. Despite their importance, specific training on WWLST remains limited.
Study Objective: evaluating the impact of a serious game on medical students' knowledge and skills regarding WWLST in ICU Population: The study population consists of 164 medical students who are randomly assigned to two groups Study design: prospective, multicenter, randomized controlled, single-blind study. The study will compare two educational approaches: a 25-minute serious game (SG) and a 25-minute narrated PowerPoint lecture (PPL) Parameters: 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 in ICU. Secondary outcomes include a multiple-choice 10 questions (MCQ), two Script Concordance Tests (SCTs) immediately after training and satisfaction scales Hypothesis: A serious game-based training program on a highly complex topic such as WWLST in ICU could enable medical students to develop better skills and experience greater satisfaction compared to a conventional teaching method.
Detailed description
The HUGS study ("Helpful Use of serious Game in life-Sustaining withdrawal") is a prospective, multicenter, randomized controlled, single-blind study evaluating the impact of a serious game on medical students' knowledge and skills regarding Withholding and withdrawing life-sustaining treatments (WWLST) in ICU WWLST are frequent in ICU and raise important ethical, legal, and communication issues. In France, these decisions are governed by the Claeys-Leonetti law, which emphasizes respect for patients' wishes, avoidance of unreasonable treatment, collegial decision-making, consultation with an external physician, and documentation. Despite their importance, specific training on WWLST remains limited.
The study will compare two educational approaches: a 25-minute serious game (SG) and a 25-minute narrated PowerPoint lecture (PPL). The serious game was developed to strengthen knowledge of the decision-making process, ethical considerations, and communication with healthcare 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 in ICU. Secondary outcomes include a multiple-choice 10 questions (MCQ) and two Script Concordance Tests (SCTs) immediately after training, satisfaction with the educational method, and self-assessment of competence following the OSCE.
Participants will be medical students in years DFASM1-3 undertaking internships in anesthesia and intensive care departments of the PARABOL university medical group. Eligible participants must be aged 18 or older. Students who have previously completed the 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 inclusion period will last 12 months. Using a previously published distribution of OSCE scores among medical students (standard deviation = 5 points), and assuming 90% power with a two-sided type I error of 5%, the required sample size was calculated to be 164 participants (82 per group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serious game (SG) on WWLST | Other | Other: serious game (SG) on WWLSTinnovative, game-based teaching approach |
| powerpoint lecture (PPL) on WWLST | Other | Other: powerpoint lecture (PPL) on WWLSTconventional teaching method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- students from "Université Paris Cité" (UPC, Paris, France), completing internships in 5 ICU
Key exclusion criteria (1 listed)
- prior participation in the WWLST serious game or previous exposure to the control training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serious game (SG) on WWLSTserious game (SG) on WWLST | Other | serious game (SG) on WWLST |
| powerpoint lecture (PPL) on WWLSTpowerpoint lecture (PPL) on WWLST | Other | powerpoint lecture (PPL) on WWLST |
Primary outcome
WWLST competencies in the ICU
Time frame: end of the 3-month ICU internship
Objective Structured Clinical Examination (OSCE) score (out of 17) assessing WWLST competencies in the ICU
6 secondary outcomes
communication skills and attitudes
Time frame: end of the 3-month ICU internship
clinical aptitude
Time frame: end of the 3-month ICU internship
knowledge assessment
Time frame: end of the 3-month ICU internship
Script Concordance Tests
Time frame: end of the 3-month ICU internship
satisfaction with the training modality
Time frame: end of the 3-month ICU internship
participants' perceived competence
Time frame: end of the 3-month ICU internship
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sebastien tanaka study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious game (SG) on WWLST and powerpoint lecture (PPL) on WWLST in people with Medical Students in Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WWLST competencies in the ICU (time frame: end of the 3-month ICU internship). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.