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

NCT06062797 | Unknown FDA Device

• 1 other identifier: 22-0936
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Mixed Reality

EXPERIMENTAL

Fracture visualization via Mixed Reality Viewer

Device: Mixed Reality Viewer

X-ray or CT scan

ACTIVE COMPARATOR

Fracture visualization via X-ray or CT scan

Device: X-ray or CT scan

Interventions

Mixed Reality Viewer DEVICE

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.

Mixed Reality

X-ray or CT scan DEVICE

X-ray or CT scan enables the visualization of the fracture in 2D.

X-ray or CT scan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (1)

Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Wrist Fractures; Ankle Fractures; Shoulder Fractures; Patient Satisfaction

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Ankle Injuries; Leg Injuries; Shoulder Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Fabian Gilbert, PD Dr. med

  LMU Munich

  STUDY DIRECTOR

Central Study Contacts

Rouven Neudeck

CONTACT

+49 (0)894400-83203; r.neudeck@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 2, 2023
• Study Start: April 18, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

DE (1)