Clinical trials: Informed Consent Process
Skeletal Deformities, Orthognathic Surgical Procedures
Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery
The goal of this clinical trial is to learn whether using three dimensional (3D)-printed anatomical models improves the informed consent process for participants undergoing orthognathic surgery.
- Conditions
- Skeletal Deformities, Orthognathic Surgical Procedures, Anxiety, Patient Education
- Trial name
- NCT07068412
- Testing
- 3D-printed Orthognathic Surgical Simulation, 2D Visual Representations of Skeletal Movements in Orthognathic Surgery
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 60 people
- Sponsor
- King Abdulaziz University
Age-related Macular Degeneration, Retinal Vein Occlusion
Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections
Evaluation if a computer-based tutorial ("MacInfo" tool) improves the patients' knowledge about intravitreal drug injections, associated risks, and the underlying diseases of treatment-naive patients.
- Conditions
- Age-related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema
- Trial name
- NCT04142164
- Testing
- MacInfo presentation
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
Pregnancy, Caesarean Section
A Multimedia Presentation to Augment the Informed Consent Process for Anesthesia for Patients Undergoing Scheduled Caesarian Delivery
The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients.
- Trial name
- NCT06945250
- Testing
- Experimental Audio Visual
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Northwestern University
HIV-1-infection
D²EFT Graphical Informed Consent
D²EFT-GIC is a substudy of D²EFT study (NCT03017872), a randomised clinical trial of second-line antiretroviral therapies. The goal of D²EFT-GIC is to evaluate a novel tool, the "Graphical Informed Consent" (GIC), within D²EFT.
- Trial name
- D²EFT-GIC (NCT04668443)
- Testing
- Graphical Informed Consent (GIC)
- Where
- Nigeria
- Volunteers
- 12 people
- Sponsor
- Kirby Institute
Critically Ill, Ethics
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
The study will explore barriers in the process of achieving informed consent from critically ill patients
- Conditions
- Critically Ill, Ethics, Informed Consent, Study Recruitment
- Trial name
- NCT03405766
- Where
- Norway
- Volunteers
- 70 people
- Sponsor
- Oslo University Hospital
Patients' Information Level About Cataract Surgery, Patients' Attitude Before and After Cataract Surgery
Computer-based Tutorial as a Means to Enhance the Informed Consent Process for Cataract Surgery
Informing the patient and obtaining the informed consent is one of the major duties physicians perform before beginning a medical treatment.
- Trial name
- NCT07167576
- Testing
- Catinfo tool and discussion with physician, discussion with physician
- Where
- Austria
- Volunteers
- 90 people
- Sponsor
- Vienna Institute for Research in Ocular Surgery
Cancer, Alzheimer Disease
Implement and Test Visual Consent Template and Process
The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level.
- Trial name
- NCT06804837
- Testing
- Visual consent, Standard consent
- Where
- 3 sites in United States
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Improving Informed Consent Process
Use of a Multimedia Presentation for Informed Consent
This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process.
- Trial name
- NCT01955070
- Testing
- Multimedia Presentation for Ketamine sedation
- Where
- United States
- Volunteers
- 184 people
- Sponsor
- Nationwide Children's Hospital
Consent Form
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
This study evaluates a visual Informed Consent Form (ICF) compared to a standard, text-only ICF as an approach to achieving meaningful consent into a clinical trial.
- Trial name
- NCT07122960
- Testing
- Visual ICF, Text-only ICF
- Where
- South Africa
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Columbia University
Hysteroscopy Surgery, Informed Consent
Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures
Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction.
- Trial name
- NCT04614688
- Testing
- Patient Education Platform
- Volunteers
- 78 people
- Sponsor
- Unity Health Toronto
Patient Education
Rapid Prototyping Models for Patient Education
Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.
- Trial name
- NCT02718807
- Testing
- RP model explanation and questionnaire
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Informed Consent, Patient and Caregiver Satisfaction
Evaluating Patient and Caregiver Satisfaction with the Informed Consent Process in Surgery
The goal of this observational study is to evaluate patient and caregiver satisfaction with the informed consent process in surgical practice at a tertiary care center in Nepal.
- Trial name
- NCT06746207
- Testing
- Informed Consent Process Evaluation
- Where
- Nepal
- Volunteers
- 384 people
- Sponsor
- Maharajgunj Medical Campus
Distal Radius Fractures, Ankle Fractures
Improving Patient Understanding in 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.
- Conditions
- Distal Radius Fractures, Ankle Fractures, Proximal Humeral Fracture
- Trial name
- NCT06062797
- Testing
- Mixed Reality Viewer, X-ray or CT scan
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- LMU Klinikum
Cataract
AI-Enhanced Consent for Cataract Surgery
This research focuses on enhancing the informed process for patients before undergoing cataract surgery. Currently, this process involves verbal discussions and written materials that may not fully address patients' understanding…
- Trial name
- NCT06528509
- Testing
- AI-Generated Informative Videos, Standard Written Information Brochures
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people
- Sponsor
- Moorfields Eye Hospital NHS Foundation Trust
Cataract
Computer-based Tutorial as Supportive Means to Enhance the Informed Consent Process for Cataract Surgery
To assess whether a computer-based tutorial as supportive means enhances quality and efficiency of the informed consent process for cataract surgery focussing on the patients' attitude before and after surgery.
- Trial name
- NCT04975126
- Testing
- CatInfo tool
- Where
- Austria
- Volunteers
- 150 people
- Sponsor
- Vienna Institute for Research in Ocular Surgery
Sickle Cell Disease
Motivations, Expectations, and Decision-making of Sickle Cell Patients in Clinical Research
Background: Sickle cell disease is an inherited blood disorder. People with this disease have a problem with their hemoglobin. That is a protein in red blood cells that carries oxygen in the body.
- Trial name
- NCT03709303
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Patient Satisfaction
The Use of an Online Learning and Consent Platform in Infertility Treatment
The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online…
- Trial name
- NCT03962257
- Testing
- EngagedMD online learning platform
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Cleft Palate, Jaw Abnormalities
Improving Informed Consent for Cleft Palate Repair
To determine if providing a written document in addition to the standard oral discussion of surgical risks improves risk recall for the parents/guardians of a child seen in consultation for cleft palate surgery, and if this has…
- Conditions
- Cleft Palate, Jaw Abnormalities, Maxillofacial Abnormalities, Mouth Abnormalities
- Trial name
- NCT02595307
- Testing
- Pamphlet
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- IWK Health Centre
Staphylococcus Aureus Bacteremia
Evaluating Simplified Layered Consent for Clinical Trials
The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of…
- Trial name
- SIMPLY-SNAP (NCT06168474)
- Testing
- Simplified layered consent form, Full-length consent form
- Where
- 6 sites in Canada
- Volunteers
- 347 people
- Sponsor
- Sunnybrook Health Sciences Centre
Cataract, Surgery
Video-assisted Informed Consent for Cataract Surgery
The investigators will investigate whether video-assisted informed consent is superior to routine discussion for cataract patients about risks, benefits and alternatives to receiving phacoemulsification cataract extract and…
- Trial name
- NCT02185807
- Testing
- video-assisted group, control group
- Where
- 2 sites in China
- Volunteers
- 80 people
- Sponsor
- Guangzhou First People's Hospital