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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03555760
Other study ID # 08/07
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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