Virtual Reality for Patient Informed Consent in Neurosurgery
ConditionVR-based Informed Consent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Visual or auditory impairment with no sufficient aid
Patient that had VR informed consent for surgery before
Psychiatric illness, cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
VR-based patient informed consent
Other interventionThe "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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: VR-based patient informed consentExperimental treatment 1 intervention
Group B: Standard of care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Comparison of intensity of anxiety between intervention and control group
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)
Time frame
one time assessment at day 12
Comparison of patient doctor relationship between intervention and control group
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.
Time frame
one time assessment at day 1Sponsors and contacts
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Source ClinicalTrials.gov