Informed Consent Clinical Trial
Official title:
Observational Investigation of Patients' Readings of Pre-operative Informed Consent Forms
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 |
Verified date | February 2019 |
Source | Ankara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University Faculty of Dentistry | Ankara | Yenimahalle |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
Turkey,
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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