VR-based Informed ConsentNCT06627426
Virtual Reality for Patient Informed Consent in Neurosurgery
A study testing VR-based patient informed consent in people with VR-based Informed Consent, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- VR-based Informed Consent
- What is being tested?
- VR-based patient informed consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Oct 2024to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Visual or auditory impairment with no sufficient aid
- Patient that had VR informed consent for surgery before
- Psychiatric illness, cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Emilia Westarp, Dr. med., +41 61 32 87187, emilia.westarp@usb.ch
Raphael Guzman, Prof. Dr., +41 61 32 87522, raphael.guzman@usb.ch
About this study
Official title: Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled 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.
Read the 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.
- Conditions
- VR-based Informed Consent
- Being tested
- VR-based patient informed consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based patient informed consentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-based patient informed consent | Experimental | 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 and enable them to use the VR system by themselves. Receives: Other: VR-based patient informed consent |
| Standard of care group | No intervention | Group that will receive standard written informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one time assessment at day 1
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.
Measured: one time assessment at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start22 Oct 2024
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VR-based Informed ConsentStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open controlled
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Westarp, Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627426
- Sponsor's protocol ID
- ko24guzman3; 2024-01819
- Status last verified
- Feb 2025
- First submitted
- 2 Oct 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06627426
- Acronym / sponsor ID
- ko24guzman3; 2024-01819
- Conditions
- VR-based Informed Consent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open controlled
| Arm | Type | Receives |
|---|---|---|
| VR-based patient informed consent | Experimental | Other: VR-based patient informed consentThe "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 and enable them to use the VR system by themselves. |
| Standard of care group | No intervention | –Group that will receive standard written informed consent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Visual or auditory impairment with no sufficient aid
- Patient that had VR informed consent for surgery before
- Psychiatric illness, cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-based patient informed consentThe "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. | Other | VR-based patient informed consent |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Related trials for VR-based Informed Consent
RecruitingObservational study
VR in Neurosurgery: Planning, Training & Communication
Brain Pathology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilia Westarp, Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based patient informed consent in people with VR-based Informed Consent, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael Guzman, Prof. Dr. (+41 61 32 87522, raphael.guzman@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of intensity of anxiety between intervention and control group (time frame: one time assessment at day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.