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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Fractures; Proximal Humeral Fracture; Distal Radius Fractures
• Intervention / Treatment: Device: Mixed Reality Viewer; Device: X-ray or CT scan

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rouven Neudeck; Phone Number: +49 (0)894400-83203; Email: r.neudeck@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich
      • Contact: Rouven Neudeck; Phone Number: +49 (0)894400-83203; Email: r.neudeck@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mixed Reality; Fracture visualization via Mixed Reality Viewer	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.
Active Comparator: X-ray or CT scan; Fracture visualization via X-ray or CT scan	Device: X-ray or CT scan; X-ray or CT scan enables the visualization of the fracture in 2D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Study Director: Fabian Gilbert, PD Dr. med, LMU Munich

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Informed Consent; Patient Education; Patient Satisfaction; Distal Radius Fracture; Proximal Humeral Fracture; Ankle Fracture; Mixed Reality
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Shoulder Injuries; Arm Injuries; Forearm Injuries; Ankle Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Ankle Fractures; Humeral Fractures; Shoulder Fractures; Wrist Fractures
• Other Study ID Numbers: 22-0936

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes