Clinical trial NCT06062797: Improving Patient Understanding in Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer
Official title: Improving Patient Understanding in the Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Ankle Fractures
Proximal Humeral Fracture
Keywords: Distal Radius Fracture
Proximal Humeral Fracture
Ankle Fracture
Mixed Reality
Patient Education
Informed Consent
Patient Satisfaction
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Understanding
timeFrame: Measurement is assessed via a questionnaire immediately after the procedure.
measure: Patient Satisfaction with the educational process assessed by the 6-point Likert scale
timeFrame: Measurement is assessed via a questionnaire immediately after the procedure.
measure: Patient Preoperative Anxiety
timeFrame: Measurement is assessed via a questionnaire immediately after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich
state: Bavaria
Study officials:
affiliation: LMU Munich
name: Fabian Gilbert, PD Dr. med
role: STUDY_DIRECTOR
References: