Patients' Readings of Pre-operative Informed Consent Forms

NCT ID: NCT03555760

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2019-01-28

Brief Summary

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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.

Detailed Description

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Conditions

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Informed Consent Awareness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery patient

Observation of informed consent form readings of all patients who are scheduled for surgery

Observation of informed consent form readings of all patients who are scheduled for surgery

Intervention Type BEHAVIORAL

All patients who are scheduled for surgery will be observed for their initial reflex of inform consent form readings.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Cagil Vural

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara University Faculty of Dentistry

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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08/07

Identifier Type: -

Identifier Source: org_study_id

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