Patients' Readings of Pre-operative Informed Consent Forms

Completed

• Conditions: Informed Consent; Awareness
• Interventions: Behavioral: Observation of informed consent form readings of all patients who are scheduled for surgery

• Registration Number: NCT03555760
• Lead Sponsor: 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 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

Not available

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-14
• Primary Completion: 2019-01-28
• Study Completion: 2019-01-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
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

Primary Outcome Measures

Name	Time	Method
Patient demographics	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.
Observations of patient readings of informed consent forms	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.

Trial Locations

Locations (1)

Ankara University Faculty of Dentistry; 🇹🇷 Ankara, Yenimahalle, Turkey