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

Primary Purpose

Distal Radius Fractures, Ankle Fractures, Proximal Humeral Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mixed Reality Viewer
X-ray or CT scan
Sponsored by
LMU Klinikum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Distal Radius Fractures focused on measuring Distal Radius Fracture, Proximal Humeral Fracture, Ankle Fracture, Mixed Reality, Patient Education, Informed Consent, Patient Satisfaction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mixed Reality

X-ray or CT scan

Arm Description

Fracture visualization via Mixed Reality Viewer

Fracture visualization via X-ray or CT scan

Outcomes

Primary Outcome Measures

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.
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.
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..

Secondary Outcome Measures

Full Information

First Posted
September 18, 2023
Last Updated
September 25, 2023
Sponsor
LMU Klinikum
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1. Study Identification

Unique Protocol Identification Number
NCT06062797
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mixed Reality
Arm Type
Experimental
Arm Description
Fracture visualization via Mixed Reality Viewer
Arm Title
X-ray or CT scan
Arm Type
Active Comparator
Arm Description
Fracture visualization via X-ray or CT scan
Intervention Type
Device
Intervention Name(s)
Mixed Reality Viewer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
X-ray or CT scan
Intervention Description
X-ray or CT scan enables the visualization of the fracture in 2D.
Primary Outcome Measure Information:
Title
Patient Understanding
Description
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.
Time Frame
Measurement is assessed via a questionnaire immediately after the procedure.
Title
Patient Satisfaction with the educational process assessed by the 6-point Likert scale
Description
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.
Time Frame
Measurement is assessed via a questionnaire immediately after the procedure.
Title
Patient Preoperative Anxiety
Description
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..
Time Frame
Measurement is assessed via a questionnaire immediately after the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rouven Neudeck
Phone
+49 (0)894400-83203
Email
r.neudeck@med.uni-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabian Gilbert, PD Dr. med
Organizational Affiliation
LMU Munich
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rouven Neudeck
Phone
+49 (0)894400-83203
Email
r.neudeck@med.uni-muenchen.de

12. IPD Sharing Statement

Learn more about this trial

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

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