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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062797
• Other study ID #: 22-0936
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: LMU Klinikum
• Contact: Rouven Neudeck
• Phone: +49 (0)894400-83203
• Email: r.neudeck[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Indication for surgery of a distal radius fracture, upper ankle fracture, or proximal humerus fracture using plate osteosynthesis

• Age = 18 years old

• Existing signed confirmation of participation in the study

• Ability to understand a German interview and questionnaire

Exclusion Criteria:

• Epilepsy

• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
LMU Klinikum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Understanding	A questionnaire is used to determine the patients' level of understanding via content-related questions about their specific fractures. Patients answer questions on a 6-point Likert scale, with higher scores indicating better outcome.	Measurement is assessed via a questionnaire immediately after the procedure.
Primary	Patient Satisfaction with the educational process assessed by the 6-point Likert scale	A questionnaire is used to determine the patient's satisfaction with the educational process. Patients answer questions on a 6-point Likert scale, with higher scores indicating better outcome.	Measurement is assessed via a questionnaire immediately after the procedure.
Primary	Patient Preoperative Anxiety	A questionnaire is used to determine the patient's anxiety regarding their upcoming surgical procedure. Patients answer the question on a 10-point Likert scale, with higher scores indicating worse outcome..	Measurement is assessed via a questionnaire immediately after the procedure.