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Completed

NCT Number: NCT03555760

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Dentistry

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. Observations of patient readings of informed consent forms

    Time frame: 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.

  2. Patient demographics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2018
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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