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
Conditions: Anesthesia, Surgical Patients
Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

STUDY PROTOCOL 
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 
Brief Title 
Effect of Visual Aids Added to Informed Consent on Patient Understanding and 
Anesthesia Awareness 
Clinical Trial Registration 
Registry: ClinicalTrials.gov 
NCT Number: Pending (to be assigned) 
Protocol Version 
Version 1.0 
Document Date 
19 February 2026 
 
Principal Investigator 
Sultan KONUK, MD 
Specialist in Anesthesiology and Reanimation 
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 
Mehmet Akif Ersoy Mah., Vatan Cad. No:91 
Yenimahalle, Ankara, Türkiye 
Email: sultankonuk@hotmail.com 
Phone: +90 506 601 12 55 
 
Study Design 
Prospective, single-center, cluster-randomized, parallel-group, single-blinded (outcome 
assessor–blinded), controlled interventional study. 
 
Study Period 
Planned Start Date: May 1, 2026 
Planned Completion Date: September 1, 2026 
Estimated Study Duration: 4 months 

 
Study Sponsor / Responsible Institution 
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 
Department of Anesthesiology and Reanimation 
Ankara, Türkiye 
 
Study Location 
Anesthesia Outpatient Clinic 
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 
Ankara, Türkiye 
 
Background and Rationale 
Informed consent is a fundamental ethical and legal requirement that ensures patients 
make voluntary decisions based on adequate and comprehensible medical information. 
Anesthesia-related procedures involve complex processes and rare but serious 
complications, making effective communication particularly critical. 
Previous literature has demonstrated that standard written informed consent forms 
frequently exceed average patient health literacy levels and may not ensure true 
comprehension. Studies indicate that patients often have limited understanding of 
anesthesia techniques, potential complications, and rare but ethically significant risks. 
Visual and multimedia-supported educational tools have been shown to improve 
comprehension, reduce cognitive load, and enhance recall of medical information. 
However, limited data exist regarding structured infographic-supported consent 
processes evaluated through validated outcome measures within a cluster-randomized 
design to minimize contamination bias. 
This study aims to address this methodological and clinical gap. 
 
Study Objective 
To evaluate whether providing visual aid–supported information in addition to the 
standard written informed consent form improves: 
1. Patient understanding of informed consent 
2. Anesthesia knowledge level 
3. Awareness of anesthesia-related risks 

4. Overall anesthesia awareness 
 
Hypotheses 
Null Hypothesis (H0): 
There is no difference between patients receiving visual aid–supported informed 
consent and those receiving standard written consent alone in terms of anesthesia 
knowledge, risk awareness, consent comprehension, or perceived adequacy of 
information. 
Alternative Hypothesis (H1): 
Patients receiving visual aid–supported informed consent will demonstrate significantly 
higher anesthesia knowledge, risk awareness, consent comprehension, and perceived 
adequacy of information compared to those receiving standard written consent alone. 
 
Study Population 
Adult patients presenting to the anesthesia outpatient clinic for elective surgery 
evaluation. 
Inclusion Criteria 
• 
Age ≥ 18 years 
• 
Able to read and understand Turkish 
• 
Scheduled for elective surgery 
• 
Willing to participate in the study 
Exclusion Criteria 
• 
Age < 18 years 
• 
Emergency surgery 
• 
Cognitive impairment 
• 
Severe visual or hearing impairment preventing communication 
• 
Refusal to participate 
 
Sample Size 
Sample size was calculated using G*Power 3.1.9.7 for independent group comparison: 
• 
Effect size (Cohen’s d): 0.5 

• 
Alpha (Type I error): 0.05 
• 
Power (1-β): 0.90 
Initial required sample: 172 patients (86 per group). 
Considering cluster randomization: 
• 
Mean cluster size: 10 
• 
ICC: 0.02 
• 
Design effect: 1.18 
Adjusted sample size: 203 patients. 
Accounting for 15% potential attrition: 
Final planned sample size: 236 patients (approximately 118 per group). 
 
Randomization and Allocation 
Cluster randomization will be applied to minimize contamination risk. 
• 
Patients will be grouped into clusters of 10 consecutive participants. 
• 
Each cluster will be randomly assigned to: 
o Control Group 
o Intervention Group 
• 
Each cluster will receive only one intervention type. 
• 
Multiple group interventions will not be conducted simultaneously on the same 
day. 
 
Interventions 
Control Group 
Standard written anesthesia informed consent form + standardized verbal explanation 
by the same anesthesiologist. 
Intervention Group 
Standard written anesthesia informed consent form + structured visual aid–supported 
educational material + standardized verbal explanation by the same anesthesiologist. 
All information sessions will be conducted: 

• 
By the same anesthesiology specialist 
• 
Using identical core verbal content 
• 
In the same outpatient clinic environment 
 
Outcome Measures 
Primary Outcome 
Informed Consent Comprehension Score 
Measured 30 minutes after the information session using a structured questionnaire. 
 
Secondary Outcomes 
• 
Anesthesia Knowledge Score 
• 
Anesthesia-Related Risk Awareness Score 
• 
Total Knowledge Score 
• 
Perceived Adequacy of Information (Likert-based scale) 
 
Data Collection Instrument 
A structured questionnaire developed based on the institution’s standard anesthesia 
consent form. 
Structure: 
1. Demographic and clinical characteristics 
2. 20 objective knowledge questions (True / False / I don’t know) 
3. 10 Likert-type items evaluating perception of information adequacy and 
awareness 
Content validity was established through expert review (Academic Test Committee 
approval dated January 16, 2026). 
 
Blinding 
Single-blind design: 
• 
Outcome assessor blinded to group allocation 

• 
Questionnaire administered by an anesthesiologist not involved in the 
information session 
• 
Questions read via standardized audio recording to avoid tone-related bias 
• 
Administered in a quiet, distraction-free setting 
 
Statistical Analysis 
Data will be analyzed using SPSS (IBM SPSS Statistics) or equivalent software. 
Descriptive statistics: 
• 
Continuous variables: Mean ± SD or median (min–max) 
• 
Categorical variables: Frequency and percentage 
Comparative analysis: 
• 
Independent t-test or Mann–Whitney U test (continuous variables) 
• 
Chi-square or Fisher’s exact test (categorical variables) 
Statistical significance threshold: p < 0.05 
 
Ethical Considerations 
• 
Ethics Committee approval will be obtained prior to study initiation. 
• 
Participation is voluntary. 
• 
Written informed consent will be obtained from all participants. 
• 
Personal data will be anonymized. 
• 
Data will be stored securely for 5 years in accordance with regulations. 
 
Budget 
Stationery and printing costs: 1000 TL 
No external funding. 
 
Study Center 

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 
Department of Anesthesiology and Reanimation 
Ankara, Türkiye