AnesthesiaNCT07461480
Effect of Visual Aids Added to Informed Consent on Patient Understanding and Anesthesia Awareness
An observational study of Anesthesia and Surgical Patients, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
Trial summary
This prospective cluster-randomized controlled study aims to evaluate whether visual support material provided in addition to the standard written informed consent form improves patients' comprehension of informed consent and their level of anesthesia awareness in an anesthesia outpatient clinic setting. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Anesthesia, Surgical Patients
- What is being tested?
- Standard Informed Consent and Visual Support Supplemented Informed Consent
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of adult patients presenting to the anesthesia outpatient clinic for routine preoperative evaluation prior to elective surgical procedures requiring anesthesia. Participants will be recruited consecutively during the preoperative assessment period. The study includes patients who are able to read and understand Turkish and who are capable of providing informed consent. Patients undergoing emergency surgery, individuals with known cognitive impairment, and those unable to complete the questionnaire will be excluded. This population represents typical preoperative anesthesia outpatients in a tertiary care hospital setting.
Who may be able to join
- Age ≥ 18 years
- Patients presenting to the anesthesia outpatient clinic for preoperative -evaluation
- Scheduled for elective surgery requiring anesthesia
- Able to read and understand Turkish
- Able to provide informed consent
- Willing to participate in the study
Who cannot join
- Age under 18 years
- Emergency surgery cases
- Known cognitive impairment or diagnosed psychiatric disorder affecting comprehension
- Visual or hearing impairment preventing adequate communication Illiteracy
- Previous participation in this study
- Refusal to participate
About this study
Official title: The Effect of Visual Aids Used in Addition to the Informed Consent Form on Understanding of Consent and Level of Anesthesia Awareness in Patients Attending the Anesthesia Outpatient Clinic
This prospective cluster-randomized controlled study aims to evaluate whether visual support material provided in addition to the standard written informed consent form improves patients' comprehension of informed consent and their level of anesthesia awareness in an anesthesia outpatient clinic setting.
Patients presenting to the anesthesia outpatient clinic will be allocated in clusters to receive either standard written informed consent alone or standard consent supplemented with structured visual support material. All patients will receive standardized verbal information delivered by the same anesthesiologist.
Read more
Thirty minutes after the information session, comprehension of informed consent and anesthesia awareness levels will be assessed using a structured questionnaire administered in a standardized manner by a blinded anesthesiologist.
The primary objective is to determine whether visual support enhances patient understanding of informed consent. Secondary objectives include evaluating its effect on anesthesia-related risk awareness and overall anesthesia knowledge.
Read the detailed description
Informed consent is a fundamental ethical and legal component of anesthesia practice. However, previous literature has demonstrated that patients frequently have limited understanding of anesthesia procedures, associated risks, and their rights within the consent process. Written informed consent forms are often complex and may exceed recommended readability levels, potentially reducing comprehension.
This study is designed as a prospective, cluster-randomized controlled trial conducted in an anesthesia outpatient clinic. The objective is to evaluate whether supplementing standard written informed consent with structured visual support material improves patients' comprehension of the consent process and their level of anesthesia awareness.
Patients presenting to the anesthesia outpatient clinic for preoperative evaluation will be allocated in clusters of ten to one of two study arms:
Control Group: Standard written informed consent form.
Intervention Group: Standard written informed consent form supplemented with structured visual support material designed to present anesthesia-related information in simplified and visually supported format.
All patients will receive standardized verbal information delivered by the same anesthesiologist to minimize variability in explanation. The visual support material was developed based on current anesthesia guidelines and health communication principles.
To reduce assessment bias, outcome evaluation will be performed by a second anesthesiologist who is blinded to group allocation. Thirty minutes after completion of the information session, patients will complete a structured questionnaire assessing:
Comprehension of informed consent
Awareness of anesthesia procedures
Awareness of anesthesia-related risks and complications
The primary outcome measure is the difference between groups in informed consent comprehension scores. Secondary outcomes include differences in anesthesia awareness and risk recognition scores.
The study aims to provide evidence on whether visually supported communication strategies can enhance patient-centered informed consent processes in anesthesia practice.
- Conditions
- Anesthesia, Surgical Patients
- Being tested
- Standard Informed Consent, Visual Support Supplemented Informed Consent
- Keywords
- Informed Consent, Visual Support, Health Communication, Cluster Randomized Trial, Anesthesia Outpatient Clinic, Risk Awareness, Patient Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Informed ConsentOther
Participants in this arm will receive the standard written informed consent form routinely used in the anesthesia outpatient clinic. In addition, standardized verbal information about anesthesia procedures, risks, and perioperative processes will be provided by the same anesthesiologist.
Visual Support Supplemented Informed ConsentOther
Participants in this arm will receive the standard written informed consent form supplemented with structured visual support material designed to enhance comprehension of anesthesia procedures, risks, and patient rights. Standardized verbal information will also be provided by the same anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Standard Informed Consent Group | Not described Receives: Other: Standard Informed Consent | |
| Visual support group | Not described Receives: Other: Visual Support Supplemented Informed Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed Consent Comprehension Score
The Anesthesia Preoperative Information and Informed Consent Comprehension Questionnaire is used to assess patients' understanding of the anesthesia informed consent process. The questionnaire includes 20 objective knowledge questions related to anesthesia procedures, risks, and patient rights. Each correct answer receives 1 point, while incorrect or "I do not know" responses receive 0 points. The total score ranges from 0 to 20, with higher scores indicating better understanding of the informed consent information.
Measured: 30 minutes after completion of the informed consent information session
Secondary outcomes (1)
Anesthesia Awareness Score
- Anesthesia Knowledge Score Measured using the Anesthesia Preoperative Information and Informed Consent Comprehension Questionnaire knowledge section. The score ranges from 0 to 20, with higher scores indicating greater knowledge about anesthesia procedures and perioperative care.
- Anesthesia Risk Awareness Score Assessed using questionnaire items related to awareness of common and rare anesthesia-related risks. Scores range from 0 to 10, with higher scores indicating greater awareness of anesthesia-related risks.
- Perceived Adequacy of Information Score Measured using Likert-scale items evaluating patient perception of the adequacy and clarity of the information provided. The total score ranges from 10 to 50, with higher scores indicating greater perceived adequacy of the information provided during the consent process.
Measured: 30 minutes after completion of the informed consent information session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULTAN KONUK, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461480
- Sponsor's protocol ID
- 2026-02/32
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual Aids Used in Addition to the Informed Consent Form on Understanding of Consent and Level of Anesthesia Awareness in Patients Attending the Anesthesia Outpatient Clinic
- ClinicalTrials.gov ID
- NCT07461480
- Acronym / sponsor ID
- 2026-02/32
- Conditions
- Anesthesia, Surgical Patients
- Keywords
- Informed Consent, Visual Support, Health Communication, Cluster Randomized Trial, Anesthesia Outpatient Clinic, Risk Awareness, Patient Education
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
This prospective cluster-randomized controlled study aims to evaluate whether visual support material provided in addition to the standard written informed consent form improves patients' comprehension of informed consent and their level of anesthesia awareness in an anesthesia outpatient clinic setting.
Patients presenting to the anesthesia outpatient clinic will be allocated in clusters to receive either standard written informed consent alone or standard consent supplemented with structured visual support material. All patients will receive standardized verbal information delivered by the same anesthesiologist.
Thirty minutes after the information session, comprehension of informed consent and anesthesia awareness levels will be assessed using a structured questionnaire administered in a standardized manner by a blinded anesthesiologist.
The primary objective is to determine whether visual support enhances patient understanding of informed consent. Secondary objectives include evaluating its effect on anesthesia-related risk awareness and overall anesthesia knowledge.
Detailed description
Informed consent is a fundamental ethical and legal component of anesthesia practice. However, previous literature has demonstrated that patients frequently have limited understanding of anesthesia procedures, associated risks, and their rights within the consent process. Written informed consent forms are often complex and may exceed recommended readability levels, potentially reducing comprehension.
This study is designed as a prospective, cluster-randomized controlled trial conducted in an anesthesia outpatient clinic. The objective is to evaluate whether supplementing standard written informed consent with structured visual support material improves patients' comprehension of the consent process and their level of anesthesia awareness.
Patients presenting to the anesthesia outpatient clinic for preoperative evaluation will be allocated in clusters of ten to one of two study arms:
Control Group: Standard written informed consent form.
Intervention Group: Standard written informed consent form supplemented with structured visual support material designed to present anesthesia-related information in simplified and visually supported format.
All patients will receive standardized verbal information delivered by the same anesthesiologist to minimize variability in explanation. The visual support material was developed based on current anesthesia guidelines and health communication principles.
To reduce assessment bias, outcome evaluation will be performed by a second anesthesiologist who is blinded to group allocation. Thirty minutes after completion of the information session, patients will complete a structured questionnaire assessing:
Comprehension of informed consent
Awareness of anesthesia procedures
Awareness of anesthesia-related risks and complications
The primary outcome measure is the difference between groups in informed consent comprehension scores. Secondary outcomes include differences in anesthesia awareness and risk recognition scores.
The study aims to provide evidence on whether visually supported communication strategies can enhance patient-centered informed consent processes in anesthesia practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Informed Consent Group | – | Other: Standard Informed Consent |
| Visual support group | – | Other: Visual Support Supplemented Informed Consent |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of adult patients presenting to the anesthesia outpatient clinic for routine preoperative evaluation prior to elective surgical procedures requiring anesthesia. Participants will be recruited consecutively during the preoperative assessment period. The study includes patients who are able to read and understand Turkish and who are capable of providing informed consent. Patients undergoing emergency surgery, individuals with known cognitive impairment, and those unable to complete the questionnaire will be excluded. This population represents typical preoperative anesthesia outpatients in a tertiary care hospital setting.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patients presenting to the anesthesia outpatient clinic for preoperative -evaluation
- Scheduled for elective surgery requiring anesthesia
- Able to read and understand Turkish
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Age under 18 years
- Emergency surgery cases
- Known cognitive impairment or diagnosed psychiatric disorder affecting comprehension
- Visual or hearing impairment preventing adequate communication Illiteracy
- Previous participation in this study
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 |
|---|---|---|
| Standard Informed ConsentParticipants in this arm will receive the standard written informed consent form routinely used in the anesthesia outpatient clinic. In addition, standardized verbal information about anesthesia procedures, risks, and perioperative processes will be provided by the same anesthesiologist. | Other | Standard Informed Consent Group |
| Visual Support Supplemented Informed ConsentParticipants in this arm will receive the standard written informed consent form supplemented with structured visual support material designed to enhance comprehension of anesthesia procedures, risks, and patient rights. Standardized verbal information will also be provided by the same anesthesiologist. | Other | Visual support group |
Primary outcome
Informed Consent Comprehension Score
Time frame: 30 minutes after completion of the informed consent information session
The Anesthesia Preoperative Information and Informed Consent Comprehension Questionnaire is used to assess patients' understanding of the anesthesia informed consent process. The questionnaire includes 20 objective knowledge questions related to anesthesia procedures, risks, and patient rights. Each correct answer receives 1 point, while incorrect or "I do not know" responses receive 0 points. The total score ranges from 0 to 20, with higher scores indicating better understanding of the informed consent information.
1 secondary outcome
Anesthesia Awareness Score
Time frame: 30 minutes after completion of the informed consent information session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Surgical Patients, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Informed Consent Comprehension Score (time frame: 30 minutes after completion of the informed consent information session). 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 17 Mar 2026.