ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Cagil Vural, Ankara University

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Surgery patient
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled for surgery and legal guardian of patients under the age of 18.
Criteria

Inclusion Criteria:

  • Being scheduled for surgery.
  • Accept being part of the study and share information such as inform consent form readings and demographics.

Exclusion Criteria:

  • Not to accept being part of the study and share information such as inform consent form readings and demographics.

Information from the National Library of Medicine

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


Contacts
Contact: Cagil Vural, MD, Specialist 905324750545 cagilvural@hotmail.com

Locations
Turkey
Ankara University Faculty of Dentistry Recruiting
Ankara, Yenimahalle, Turkey, 06560
Contact: Cahit Ucok, Prof. Dr.    903122965590    cucok@dentistry.ankara.edu.tr   
Sponsors and Collaborators
Ankara University

Responsible Party: Cagil Vural, Instructor, Ankara University
ClinicalTrials.gov Identifier: NCT03555760     History of Changes
Other Study ID Numbers: 08/07
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No