Improving Patient Understanding in Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer
NCT ID: NCT06062797
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-04-18
2023-12-31
Brief Summary
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The main questions aim to answer are:
* Does the use of the Mixed Reality Viewer improve patient understanding?
* Does the use of the Mixed Reality Viewer improve patient satisfaction?
* Does the use of the Mixed Reality Viewer reduce patient preoperative anxiety?
Participants will have their fracture presented via the Mixed Reality Viewer. Researchers will compare standard fracture imaging using X-ray or CT scans to see if there is any difference in understanding, satisfaction and anxiety.
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Detailed Description
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A better understanding of the fracture by the patients and a more comprehensible visualization of the operations can lead to better informed consent between the patients and the doctor. Consequential benefits for treatment and postoperative follow-up may follow.
The investigators hypothesis is that fracture visualization using a Mixed Reality Viewer can generate higher fracture understanding in patients. As a result of better education, this visualization method could lead to higher patient satisfaction and anxiety reduction.
Patients with an indication for surgery of a distal radius fracture, upper ankle fracture or proximal humerus fracture using plate osteosynthesis are randomized into the intervention group or the control group. Both study groups watch verbal education via a recorded video. The intervention group afterward receives a fracture visualization via mixed reality glasses. The control group receives fracture visualization via X-ray or CT scan.
In both the intervention group and the control group, the type of fracture, the extent of the fracture, the surgical method, and the benefits and risks of the surgery are explained to the patients during the visualization.
After the explanation is completed, patients are asked to complete a questionnaire regarding satisfaction and fracture understanding.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Mixed Reality
Fracture visualization via Mixed Reality Viewer
Mixed Reality Viewer
The Mixed Reality Viewer from Brainlab (Germany) enables the visualization of the fracture via a 3D hologram. In contrast to virtual reality, where the user is in a completely virtual world, the user of the mixed reality viewer sees the 3D hologram implemented in his real environment.
X-ray or CT scan
Fracture visualization via X-ray or CT scan
X-ray or CT scan
X-ray or CT scan enables the visualization of the fracture in 2D.
Interventions
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Mixed Reality Viewer
The Mixed Reality Viewer from Brainlab (Germany) enables the visualization of the fracture via a 3D hologram. In contrast to virtual reality, where the user is in a completely virtual world, the user of the mixed reality viewer sees the 3D hologram implemented in his real environment.
X-ray or CT scan
X-ray or CT scan enables the visualization of the fracture in 2D.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Existing signed confirmation of participation in the study
* Ability to understand a German interview and questionnaire
Exclusion Criteria
* Patients with mental limitations (e.g. dementia) or severe visual impairments that prevent informed consent emergency surgery
* Age \< 18 or \> 80 years old
* Inability to understand a German interview and questionnaire
18 Years
80 Years
ALL
No
Sponsors
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LMU Klinikum
OTHER
Responsible Party
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Konstantin Wehrkamp
Principal Investigator
Principal Investigators
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Fabian Gilbert, PD Dr. med
Role: STUDY_DIRECTOR
LMU Munich
Locations
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Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich
Munich, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-0936
Identifier Type: -
Identifier Source: org_study_id
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