VR-based Informed Consent
Conditions
Brief summary
The goal of this randomized controlled trial is to evaluate benefits of VR (virtual reality)-based patient informed consent in neurosurgery regarding subjective patient comprehension, patient-doctor relationship and anxiety.
Detailed description
Additionally, the investigators aim to assess the cost-benefit radio as well as feasibility in a clinical routine setting. Considering the increasing patient participation in decision-making, VR could lead to better understanding of complex surgical procedures, improving the perioperative process for both, patient and surgeon, and reduce anxiety.
Interventions
OTHERVR-based patient informed consent
The intervention group will be the on receiving VR-based patient informed consent. One surgeon from the study team will be guiding the patient through their VR model first with demonstration of the technology and the model, afterwards the patient will be enabled to use the VR system by themselves. During the whole process the patient will be able to ask questions. Depending on the planned surgery, the surgical approach as well important anatomical structures will be explained.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized, open controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients between the age of 18 and 75 * Surgical clipping for intracranial aneurysm, resection of vascular malformations * Craniotomy and Resection of intracranial tumors that can be segmented for VR
Exclusion criteria
* Visual or auditory impairment with no sufficient aid * Patient that had VR informed consent for surgery before * Psychiatric illness, cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of intensity of anxiety between intervention and control group | one time assessment at day 1 | Comparison of intensity of physical and cognitive anxiety symptoms will be assessed by the questionnaire Beck Anxiety Inventory (BAI). This questionnaire consists of 21 self-reported items (four-point scale). min score: 39 (minimal anxiety level) max score:174 (severe anxiety) |
| Comparison of patient doctor relationship between intervention and control group | one time assessment at day 1 | Comparison of patient doctor relationship will be assessed by PDRQ9 (patient-doctor relationship questionnaire). The questionnaire is a 9-item scale that assesses patients' perception of the relationship with the physician. Items are scored on a 5-point Likert scale ranging from 'not at all appropriate' to 'totally appropriate'. Raw sum scores range from 9 to 45, with higher scores indicating that the patient's perception of the patient-doctor relationship is more favorable. |
Countries
Switzerland
Contacts
Primary ContactRaphael Guzman, Prof. Dr.
Outcome results
None listed