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Informed Consent clinical trials

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NCT ID: NCT05505058 Completed - Informed Consent Clinical Trials

One-time Informed Consent for Research in Prison

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Ethical research on detained persons remains limited, including research on informed consent. This study aimed to fill in this research gap and compared audio-visual and paper-based materials for a one-time general informed consent for research in prison, using a randomized design. The primary outcome was whether participants sign the inform consent. Secondary outcomes included understanding, evaluation, and time to read/watch the informed consent.

NCT ID: NCT05414435 Completed - Informed Consent Clinical Trials

Informed Consent in Endoscopy: Read, Understood or Merely Signed?

Start date: April 1, 2021
Phase:
Study type: Observational

Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed. The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.

NCT ID: NCT05188547 Completed - Anxiety Clinical Trials

Information Retention After Video (Augmented) Preoperative Anesthesiological Education

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Patient education is continuously becoming more important to enable patients to participate in making decisions regarding their medical treatment. Specifically, this is also the case for preoperative education on anesthesia. Worldwide, there are many initiatives to improve preoperative patient education and subsequent level of knowledge of anesthesia, for example by using digital aids. The demand for such aids has increased significantly since the start of the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic to facilitate remote preoperative anesthesiological screening. Although many videos to educate patients on anesthesia have been developed and circulate on the internet, there has been little effort to compare this method of educating patients with the traditional one-on-one conversation between the anesthesiologist and the patient. Objective: To compare short, mid-and long term retention of knowledge after education on anesthesia by watching a video to the traditional one-on-one explanation by the anaesthesiologist.

NCT ID: NCT04627597 Completed - Informed Consent Clinical Trials

Patients' Comprehension and Internalization of Operative Consent Form

Start date: July 1, 2016
Phase:
Study type: Observational

This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016. 22 patients planned for common elective ENT operations were given a self-administered one-page survey on the same day after preoperative counselling. The investigators aim to identify if there are any associations between perceived and actual understanding of information given during pre-operative counselling and patient satisfaction with the process.

NCT ID: NCT04493866 Completed - Quality Improvement Clinical Trials

Quality Improvement Study on Operative Consent Forms

Start date: January 6, 2020
Phase:
Study type: Observational

A Quality Improvement Project was undertaken to improve the completion of operative consent forms within a UK hospital plastic surgery department. Four weekly interventions were made which were accompanied by four further data collection cycles.

NCT ID: NCT03960723 Completed - Informed Consent Clinical Trials

Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

Start date: May 9, 2019
Phase:
Study type: Observational

The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess. The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.

NCT ID: NCT03555760 Completed - Informed Consent Clinical Trials

Patients' Readings of Pre-operative Informed Consent Forms

Start date: May 22, 2018
Phase:
Study type: Observational

Patient informed consent is a form which contains the patient's probable outcome of the procedure to be performed, and the probable risk and benefit of the patient's knowledge of the illness. On the form, completely honest and detailed information based on the facts are shared with the patient. It will be beneficial to both the physician and the patient to make a correct and complete consent procedure. The view, feelings and thoughts including the continuous and mutual understanding effort between the patient individual and the follow-up health team (physician, nurse, etc.) are essential in this sense. The information that must be provided covers all of the following: - The health status of the patient and the diagnosis, - The type of treatment proposed, - The chances of success and duration, - The risk that the treatment modality carries for the patient's health, - The use of medicines and possible side effects, - The consequences of the illness if the hospital does not accept the recommended treatment, - Alternative treatment options and risks. The informed consent is different from the signing of the patient indicating that he approves the procedure to be performed. The main purpose is to provide information to the patient and to understand this knowledge. For this reason, before the signing of the proclamation, it is necessary to ensure that the patient is informed in accordance with his or her own cultural and educational level. In addition, the patient must be audited that he/she understands the given information. The purpose of this study is to investigate whether the informed consent forms given to the patient after informing by the physician were read as the first reflex before signing.

NCT ID: NCT03503487 Completed - Communication Clinical Trials

Surgical Planning and Informed Consent

SPLICE
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

New devices for anatomic studies and 3-D visualization have proven to be useful for pre-operative surgical planning and intra-operative procedures; the hypothesis of our study is that, in this specific case scenario, Surgical Theater and Vesalius (two devices available at the Besta NeuroSim Center, Foundation I.R.C.C.S. Neurological Institute Carlo Besta) can improve doctor-patient communication during the process of obtaining informed consent: through tridimensional representation of anatomic structures of the brain, these devices are able to help patients understand better their own anatomy and the surgical approach to their disease. The aim of our study is therefore to understand whether this high-technology 3D planning, used as a tool to optimize patient-doctor communication, can effectively improve patients' understanding of the disease and the surgical procedure they will be going through (for which they are supposed to sign the consent), as well as the benefits, the risks and all the possible complications that can derive form surgery. Surgical Theater and Vesalius may be of great help: thanks to the case-specific 3D reconstruction of the patient's anatomy, the explanation of the surgical procedure could be customized for each different person, considering that anyone has certain unique individual features that a regular standardized system could not possibly take into account.

NCT ID: NCT03419832 Completed - Informed Consent Clinical Trials

The New Executive and Appendix Template (NEAT) Study

Start date: April 4, 2017
Phase: N/A
Study type: Interventional

There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to effectively inform research participants of information thought to be most important in facilitating their ability to make informed decisions about participation. The need for revisions to the informed consent document design is supported by empirical research.This pilot study will examine the effectiveness of the New Executive and Appendix Template (NEAT) form when used in the consent process for individuals participating in the Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study.

NCT ID: NCT03405766 Completed - Critically Ill Clinical Trials

Barriers in the Process of Achieving Informed Consent From Critically Ill Patients

Start date: May 2, 2018
Phase:
Study type: Observational

The study will explore barriers in the process of achieving informed consent from critically ill patients