Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04273958
Eligibility Criteria:
Inclusion Criteria:
* Patient whose care requires a medical procedure (suture, cast placement and repositioning, fracture reduction, paracentesis, thoracocentesis and lumbar puncture).
Exclusion Criteria:
* Unstable patient (e.g., admitted to the intensive care unit or deemed unstable by the physician in charge);
* Patients without decision-making capacity or with whom it is difficult to communicate:
* Altered mental status (e.g., cognitive impairment, mental retardation, acute confusional state, acute psychosis).
* Intoxication,
* Drug abuse
* Patient unable to communicate in French at a level sufficient to give informed consent and answer questions about pain and anxiety;
* Patient who is hard of hearing;
* Patient unable to see films on screen or in VR due to vision problems (e.g., blindness or without his/her glasses).
* Patients unable to understand the use of the EVA strips;
* Part of the body where the altered procedure is to be performed (e.g. sensitivity disorder, lymphedema...)
* Patient with a head injury that prevents the use of RV helmet;
* Intended use of sedation analgesia with a dissociative agent (midazolam, ketamine, propofol).
* Incarcerated patient;
* Patient transferred from another hospital;
* Patient who participated in this study at a previous consultation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04273958
Study Brief:
Protocol Section:
NCT04273958