At least 20 patients should be included in the prospective, randomized and controlled clinical trial within 6 months. The aim is to investigate whether the use of VSI Patient Education in pre epilepsy education is superior to the use of a plastic brain model.
Procedure of the examination:
Patients are randomized into two groups. In both groups, the visual aids VSI and a plastic brain model are to be used one after the other. The only difference between the groups is the order in which the tools are used. Subsequently, both the patients and their relatives present and the doctors who provide information are to answer questionnaires.
The following hypothesis is investigated:
By using the VSI, the following is achieved in comparison to the use of the brain model during surgical clarification:
- Patients feel better informed
- Patients feel safer and are less afraid of the operation
- Patients feel strengthened in their decision making regarding the surgical consent
- Patients feel diagnosed and treated according to the latest state of technology
The results of the study are scheduled for early 2019.
Epilepsy is one of the most common neurological diseases with a prevalence of about 1%. About 2/3 of all newly diagnosed epilepsies can be successfully treated with medication (Kwan and Brodie, 2000). In patients with epilepsy, who are not free of seizures despite medical treatment, the possibility of an epilepsy surgical therapy option should also be clarified quickly. If the result of a pre-surgical clarification is the indication for epilepsy surgery, the patient will be informed of this during surgery.
When a physician is required to provide information, the patient’s right of self-determination, autonomy, and freedom of decision must be respected and should take clear precedence over the medical opinion of the physician (Parzeller et al., 2007).
However, this only appears in a meaningful context if the patient feels informed about all details of the operation, including alternatives and risks, in a timely and comprehensive manner and understands the surgical procedure. It would be helpful for this if he could also visualize the operation. In order to demonstrate the patient’s brain, the lesion to be operated on and the surgical approach in as comprehensible a way as possible, the doctor in charge of the education uses aids such as imaging (especially MRIs and CTs) on foil or displayed on a PC screen, or brain models made of plastic.
To date, there has been no scientific investigation as to which surgical education strategy a patient needs to be sufficiently informed to make a decision for or against an operation. It is not investigated whether the use of mixed, augmented or virtual reality for 3-dimensional illustration of the patient’s brain, the lesion to be operated on and the surgical approach is suitable for informing the patient about the operation in an understandable and sufficient way in comparison to the visual aids mentioned above.
*(Excerpt from the official exposé for the Ethics Committee of Dr. P. House)