Virtual Reality Patient Consent in Neurosurgery
NCT Number: NCT06565234
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Pathology
Sponsor: University Hospital, Basel, Switzerland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2025-06
Locations: University Hospital Basel, Basel, 4031, Switzerland

Summary:
This prospective multicenter study compares standard patient-informed consent and virtual reality (VR) based patient-informed consent in neurosurgery regarding subjective patient comprehension, patient-doctor relationship, and anxiety.

Primary Outcome Measures: Virtual Reality-Questionnaire, To assess the individual experience in consenting of the patient, a numeric Virtual Reality-Questionnaire customized for this study is used., Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)|Shared Decision Making Questionnaire (SDM-Q-9), To assess the individual experience in consenting of the patient, the Shared Decision Making Questionnaire (SDM-Q-9) is used. The SDM-Q-9 is a 9-item questionnaire designed to measure the extent of shared decision-making between patients and healthcare providers. Each item is scored on a 6-point scale from 0 (completely disagree) to 5 (completely agree). Higher scores reflect a greater involvement of the patient in the decision-making process, indicating better shared decision-making practices., Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)|Beck Anxiety Inventory (BAI), To assess the individual experience in consenting of the patient, the Beck Anxiety Inventory (BAI) is used. The BAI is a 21-item self-report questionnaire used to assess the severity of an individual's anxiety. Each item is rated on a 4-point scale from 0 (not at all) to 3 (severely, it bothered me a lot). Higher scores indicate higher levels of anxiety, with scores categorized into minimal, mild, moderate, and severe anxiety levels., Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)|Quality of Recovery-15 (QoR-15), To assess the individual experience in consenting of the patient, the Quality of Recovery-15 (QoR-15) is used. The QoR-15 is a 15-item questionnaire used to evaluate a patient's recovery after surgery. It covers various aspects of recovery, including physical comfort, emotional state, physical independence, psychological support, and pain. Each item is rated on an 11-point scale from 0 (none of the time) to 10 (all of the time), with higher scores indicating better quality of recovery., Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
Secondary Outcome Measures: Resources required for 3D visualization, To determine the resources required to construct the 3D model, information regarding the required time, imaging modalities, and hardware is collected., Day 0 (before surgery)|Length of hospitalization, As a standard clinical parameter the length of hospitalization is determined., Up to week 1|Modified Rankin Scale (mRS), As a standard clinical parameter the Modified Rankin Scale (mRS) is assessed. The mRS is a measure used to evaluate the degree of disability or dependence in daily activities of people who have suffered neurological pathologies. The scale ranges from 0 to 6, with 0 indicating no symptoms, 1 indicating no significant disability despite symptoms, and higher scores indicating increasing levels of disability up to 5, which represents severe disability requiring constant care, and 6 indicating death. Lower scores indicate less disability, while higher scores reflect greater disability., >Day 2, Week 4, and Month 6 (after surgery)|Extended Glasgow Outcome Scale (eGOSE), As a standard clinical parameter the Extended Glasgow Outcome Scale (eGOSE) is assessed. The eGOSE is used to assess the functional outcome of patients after a brain pathology. The scale ranges from 1 to 8, with 1 indicating death and 8 indicating an upper good recovery with the patient resuming normal activities without disability. Lower scores indicate more severe disability or worse outcomes, while higher scores reflect better functional recovery and less disability., >Day 2, Week 4, and Month 6 (after surgery)