Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- VR-based Informed Consent
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Comparison of intensity of anxiety between intervention and control group
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Comparison of intensity of anxiety between intervention and control group
Time Frame: 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
Time Frame: 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.