Improving Patient Understanding in Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer

Ankle Fractures Clinical Trial

Official title: Improving Patient Understanding in the Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer

Status Recruiting

Clinical Trial Summary

This clinical trial aims to compare a Mixed Reality Viewer in the preoperative informed consent process to standard fracture visualization. The participants population are patients with an indication for surgery of a distal radius fracture, upper ankle fracture or proximal humerus fracture using plate osteosynthesis.

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.

Clinical Trial Description

In everyday clinical practice, patients receive a verbal explanation of their medical condition, optional treatment options, and information about the benefits, risks and complications of surgery during preoperative education. To visualize the respective fractures to the patients, they are shown using X-rays, CT scans or MRI images. However, these images are often difficult to understand without prior medical knowledge.

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. ;

Related Conditions & MeSH terms

• Ankle Fractures
• Distal Radius Fractures
• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Radius Fractures
• Shoulder Fractures
• Wrist Fractures

• NCT number: NCT06062797
• Study type: Interventional
• Source: LMU Klinikum
• Contact: Rouven Neudeck
• Phone: +49 (0)894400-83203
• Email: r.neudeck@med.uni-muenchen.de
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Completion date: December 31, 2023