Patients' Readings of Pre-operative Informed Consent Forms

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

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.

Study Overview

• Status: Completed
• Conditions: Informed Consent; Awareness
• Intervention / Treatment: Behavioral: Observation of informed consent form readings of all patients who are scheduled for surgery

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06560
      • Ankara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for surgery and legal guardian of patients under the age of 18.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery patient; Observation of informed consent form readings of all patients who are scheduled for surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): January 28, 2019
• Study Completion (Actual): January 28, 2019

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 08/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No