This prospective randomized controlled trial sought to assess the impact of animated video-based information given to patients prior to ESWL on anxiety levels, procedural satisfaction, readiness to undergo the treatment again, as well as perceived discomfort during the procedure. This prospective study was conducted from February to March 2023 at Sakarya University Education and Research Hospital, the largest tertiary care center in the region. Prior to the study, approval was secured from the Sakarya University Ethics Committee. Written informed consent was obtained from all participants at least 24 h before the procedure. This timeline ensured adequate time for patients to review the information, ask questions, and consider their participation without time pressure, aligning with international ethical standards for elective procedures like ESWL.

Individuals scheduled for ESWL treatment for kidney stones were randomly allocated to the study in a 1:1 ratio. Participants were randomized 1:1 to either the video or control group using a web-based randomization system with permuted blocks of size 4. The sequence was generated by the hospital’s clinical trials unit, and allocation was concealed from researchers enrolling patients. A study nurse, unaware of group assignments, implemented the interventions. The inclusion criteria were first-time ESWL recipients with radiopaque kidney stones measuring 5–20 mm in size. In addition, the study included adult patients aged ≥ 18 years without upper age restriction. The exclusion criteria included patients with kidney anomalies, those with prior Double-J stent placement, individuals unwilling to participate, patients with ureteropelvic junction stenosis, and those with severe hydronephrosis.

Before the patients started ESWL treatment, all participants’ age, gender, body mass index (BMI), State-Trait Anxiety Inventory (STAI) scores, stone location and diameters, and Hounsfield unit values ​​of the stones were recorded. STAI is an anxiety assessment questionnaire comprising 20 questions, and answers are taken on a 4-point Likert-type scale. STAI, a validated psychological assessment tool, was used to measure anxiety. Scores on the STAI range from 20 to 80, with higher values indicating greater anxiety levels [9]. The STAI consists of two subscales: state anxiety (STAI-S) and trait anxiety (STAI-T). STAI-T is a trait anxiety scale. It measures the general tendency of the person, i.e., the tendency to anxiety as a personality trait. STAI-S measures situation-specific anxiety. It evaluates the temporary anxiety level that the person feels at that moment [5]. All participants completed both the State-Trait Anxiety Inventory forms (STAI-T and STAI-S) before undergoing ESWL. Following this, animated video-based information was provided along with the standard verbal and written materials typically used for the video group. The non-video group received only the standard verbal and written materials. After completing the information process, STAI-S was applied to all participants again. Following the completion of the information process, ESWL was performed on the patients. Patient education (both verbal and video-assisted) was provided exclusively by a doctor who was not involved in performing ESWL procedures. All ESWL treatments were performed by one of three board-certified urologists blinded to group allocation. This separation of roles ensured consistency in information delivery and eliminated potential bias in treatment administration across both groups. Figure 1 presents the workflow of the study.

Diagram illustrating the process of the study

ESWL was performed using the ELMED Multimed EM lithotripter device (ELMED, Ankara, Turkey). The stone was localized and targeted using a C-arm fluoroscopy device, with the patient positioned on an electronic stretcher capable of movement in four directions and vertical adjustment within the ESWL suite. The procedure was initiated at an energy level of 1 kV and gradually increased to a maximum of 21 kV, depending on the patient’s tolerance. A pulse frequency of 80 shocks per minute was maintained, and a total of 2,500 pulses were delivered per patient. No analgesics were administered before or during the procedure. However, oral painkillers were prescribed to patients upon completion of the ESWL session to manage post-procedural discomfort.

VAS (Visual Analog Scale) is a widely used assessment tool that evaluates a person’s perceived condition, typically represented as a 10-unit straight line. One end of the line corresponds to “none” or the lowest level, while the other end represents “very severe” or the highest level. As the score approaches 10, the severity of the evaluated condition increases, whereas lower scores indicate a milder experience [4]. In our study, we adapted the VAS scale to assess willingness to repeat to the procedure, satisfaction, and pain. These evaluations took place after ESWL, and the outcomes were evaluated across the groups. In addition, the patients were monitored throughout the ESWL procedure. Hemodynamic parameters were measured and recorded, including mean systolic and diastolic blood pressures, heart rates, respiratory rates per minute, and oxygen saturation levels. These values were then compared between the groups to assess any differences in physiological responses during the procedure.

The video-animated information was sourced from the patient information section of the EAU official website (https://patients.uroweb.org/videos/shock-wave-lithotripsy-swl-video/). This short, approximately 2.5-minute video explains the ESWL procedure using 3D animation, making it easier for patients to understand the process and post-procedure expectations. Since the video is in English, a doctor accompanied the patient during the viewing to provide real-time translation. The video-animated information was presented in the same room where written and verbal consent was obtained, allowing patients to rewind the video, ask the doctor questions about unclear points, and receive further explanations.

Statistical analyses were performed using IBM SPSS Statistics version 22 (SPSS Inc., Chicago, IL, USA). The normality of data distribution was assessed using the Kolmogorov-Smirnov test. Continuous quantitative variables were presented as mean ± standard deviation (SD) for normally distributed data and non-normally distributed data; they were expressed with median and interquartile range. The independent samples t-test (Student’s t-test) was used for group comparisons of normally distributed variables, while the Mann-Whitney U test was applied for non-normally distributed variables. Categorical variables were summarized, and group comparisons were conducted using the chi-square test. A p-value below 0.05 was considered indicative of statistical significance.

The sample size for this study was calculated based on the effect sizes reported in a previous study by Kim, J. W. et al. [10], which investigated the effects of a heating pad on anxiety and pain during urodynamic studies. In their study, the State-Trait Anxiety Inventory (STAI) scores showed a mean difference of 7.1 points between the intervention and control groups, with a standard deviation (SD) of approximately 10. This corresponds to a Cohen’s d effect size of 0.71, indicating a medium-to-large effect. Using G*Power software (version 3.1.9.7) for an independent samples t-test with an alpha level of 0.05 and a power of 80%, a minimum of 34 participants per group (total 68 participants) was required to detect a similar effect size in our study. To account for potential drop-outs, we aimed to recruit 40 participants per group (total 80 participants). This sample size ensures adequate statistical power to evaluate the primary outcomes of anxiety (STAI) and pain (VAS) in our randomized prospective study.