UnknownNot Applicable

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

Germany50 participantsStarted 2023-04-18

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Understanding

Timeframe: Measurement is assessed via a questionnaire immediately after the procedure.

Patient Satisfaction with the educational process assessed by the 6-point Likert scale

Timeframe: Measurement is assessed via a questionnaire immediately after the procedure.

Patient Preoperative Anxiety

Timeframe: Measurement is assessed via a questionnaire immediately after the procedure.

Trial details

NCT IDNCT06062797

SponsorLMU Klinikum

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Rouven Neudeck

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

View on ClinicalTrials.gov More Distal Radius Fractures trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient Understanding

Timeframe: Measurement is assessed via a questionnaire immediately after the procedure.

Patient Satisfaction with the educational process assessed by the 6-point Likert scale

Timeframe: Measurement is assessed via a questionnaire immediately after the procedure.

Patient Preoperative Anxiety

Timeframe: Measurement is assessed via a questionnaire immediately after the procedure.