Patients' Readings of Pre-operative Informed Consent Forms

Informed Consent Clinical Trial

Official title:

Observational Investigation of Patients' Readings of Pre-operative Informed Consent Forms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555760
• Other study ID #: 08/07
• Status: Completed
• Start date: May 22, 2018
• Est. completion date: January 28, 2019

Study information

• Verified date: February 2019
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Awareness
• Informed Consent

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Dentistry	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observations of patient readings of informed consent forms	Visual doctor observation of initial reflex of readings of informed consent forms before signing the documents. Outcome will be noted as positive or negative.	15 minutes
Primary	Patient demographics	Demographic features of patients recruited in the study will be noted, including age, gender, occupation and educational status.	Will be noted after outcome 1- 5 minutes