Informed ConsentNCT03555760
Patients' Readings of Pre-operative Informed Consent Forms
An observational study of Informed Consent and Awareness, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent, Awareness
- What is being tested?
- Observation of informed consent form readings of all patients who are scheduled for surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2018to 28 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients scheduled for surgery and legal guardian of patients under the age of 18.
Who may be able to join
- Being scheduled for surgery.
- Accept being part of the study and share information such as inform consent form readings and demographics.
Who cannot join
- Not to accept being part of the study and share information such as inform consent form readings and demographics.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Yenimahalle, 06560
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Informed Consent, Awareness
- Being tested
- Observation of informed consent form readings of all patients who are scheduled for surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of informed consent form readings of all patients who are scheduled for surgeryBehavioural
All patients who are scheduled for surgery will be observed for their initial reflex of inform consent form readings.
| Study group | Role | What they receive |
|---|---|---|
| Surgery patient | Observation of informed consent form readings of all patients who are scheduled for surgery Receives: Behavioral: Observation of informed consent form readings of all patients who are scheduled for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Patient demographics
Demographic features of patients recruited in the study will be noted, including age, gender, occupation and educational status.
Measured: Will be noted after outcome 1- 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start22 May 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagil Vural, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555760
- Sponsor's protocol ID
- 08/07
- Status last verified
- Feb 2019
- First submitted
- 22 May 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Investigation of Patients' Readings of Pre-operative Informed Consent Forms
- ClinicalTrials.gov ID
- NCT03555760
- Acronym / sponsor ID
- 08/07
- Conditions
- Informed Consent, Awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery patient | – | Behavioral: Observation of informed consent form readings of all patients who are scheduled for surgeryObservation of informed consent form readings of all patients who are scheduled for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for surgery and legal guardian of patients under the age of 18.
Key inclusion criteria (2 listed)
- Being scheduled for surgery.
- Accept being part of the study and share information such as inform consent form readings and demographics.
Key exclusion criteria (1 listed)
- Not to accept being part of the study and share information such as inform consent form readings and demographics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of informed consent form readings of all patients who are scheduled for surgeryAll patients who are scheduled for surgery will be observed for their initial reflex of inform consent form readings. | Behavioural | Surgery patient |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Informed Consent and Awareness, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observations of patient readings of informed consent forms (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.