Patients' Readings of Pre-operative Informed Consent Forms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03555760|
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
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 our 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.
|Condition or disease||Intervention/treatment|
|Informed Consent Awareness||Behavioral: Observation of informed consent form readings of all patients who are scheduled for surgery|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Observational Investigation of Patients' Readings of Pre-operative Informed Consent Forms|
|Actual Study Start Date :||May 22, 2018|
|Estimated Primary Completion Date :||November 22, 2018|
|Estimated Study Completion Date :||February 22, 2019|
Observation of informed consent form readings of all patients who are scheduled for surgery
Behavioral: Observation of informed consent form readings of all patients who are scheduled for surgery
All patients who are scheduled for surgery will be observed for their initial reflex of inform consent form readings.
- Observations of patient readings of informed consent forms [ Time Frame: 15 minutes ]Visual doctor observation of initial reflex of readings of informed consent forms before signing the documents. Outcome will be noted as positive or negative.
- Patient demographics [ Time Frame: Will be noted after outcome 1- 5 minutes ]Demographic features of patients recruited in the study will be noted, including age, gender, occupation and educational status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555760
|Contact: Cagil Vural, MD, Specialistemail@example.com|
|Ankara University Faculty of Dentistry||Recruiting|
|Ankara, Yenimahalle, Turkey, 06560|
|Contact: Cahit Ucok, Prof. Dr. 903122965590 firstname.lastname@example.org|