- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07651384
Animated Video Versus Written Leaflet for Preoperative Kidney Transplant Education
June 13, 2026 updated by: Muhammed Emin Polat, Ankara City Hospital Bilkent
Comparing the Effects of Animated Video and Written Information on Understanding, Knowledge Level, and Anxiety in Explaining Kidney Transplant Surgery to Patients
This randomized comparative trial evaluated whether an animated educational video, added to standard verbal counselling, differs from a content-matched written information leaflet, also added to standard verbal counselling, in improving procedural knowledge and reducing preoperative anxiety among adult kidney transplant candidates and prospective living donors.
Participants were assessed immediately before and immediately after the assigned intervention.
Secondary outcomes included participant satisfaction, preferred information modality, and the understandability and actionability of the educational materials.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Adult kidney transplant candidates undergoing preoperative evaluation and their prospective living donors were randomly allocated 1:1 to a video group or a written group.
Both groups received standardized verbal counselling, unchanged across arms; the video group additionally viewed a ~2.5-minute animated video, and the written group additionally read a content-matched, illustrated A4 leaflet covering the same kidney transplant surgical pathway (laparoscopic live donor nephrectomy, bench surgery, and recipient stages).
Procedural knowledge was measured with a seven-item investigator-developed questionnaire and preoperative anxiety with the validated Turkish Amsterdam Preoperative Anxiety and Information Scale (APAIS), administered immediately before and after the intervention.
After the post-test, participants were cross-over exposed to the other format and indicated their preferred modality for future education.
The understandability and actionability of both materials were independently rated using the Patient Education Materials Assessment Tool (PEMAT-A/V and PEMAT-P).
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 18 to 75 years
- Kidney transplant candidate or prospective living donor undergoing preoperative evaluation
- Able to read and write Turkish
- Provided written informed consent
Exclusion Criteria:
- Previous exposure to the study's animated educational video
- Cognitive impairment or inability to communicate adequately for assessment
- Visual or hearing impairment preventing completion of questionnaires or viewing of the material
- Documented severe psychiatric disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video group
Standard verbal counselling plus an animated educational video.
|
Approximately 2.5-minute animation depicting the kidney transplant surgical pathway
|
|
Active Comparator: Written group
Standard verbal counselling plus a content-matched written information leaflet.
|
Illustrated A4 leaflet with content identical to the video.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in procedural knowledge
Time Frame: Day 1 (immediately before and immediately after the intervention, same study visit)
|
Procedural knowledge was measured with a 7-item investigator-developed multiple-choice Kidney Transplant Surgical Process Knowledge Questionnaire, scored as the number of incorrect responses.
Scores range from a minimum of 0 to a maximum of 7. Higher scores indicate worse knowledge (more incorrect answers); a decrease from pre- to post-test indicates a better outcome.
|
Day 1 (immediately before and immediately after the intervention, same study visit)
|
|
Change in preoperative anxiety with the Amsterdam Preoperative Anxiety and Information Scale (APAIS) score
Time Frame: Day 1 (immediately before and immediately after the intervention, same study visit)
|
Preoperative anxiety and information need were measured with the Amsterdam Preoperative Anxiety and Information Scale (APAIS), total score.
Scores range from a minimum of 6 to a maximum of 30.
Higher scores indicate a worse outcome (greater anxiety and information need); a decrease from pre- to post-test indicates a better outcome.
|
Day 1 (immediately before and immediately after the intervention, same study visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-intervention knowledge score (between groups)
Time Frame: Day 1 (immediately after the intervention, same study visit)
|
Number of incorrect responses on the 7-item Kidney Transplant Surgical Process Knowledge Questionnaire after the intervention, compared between groups.
Scores range from a minimum of 0 to a maximum of 7. Higher scores indicate worse knowledge (a worse outcome).
|
Day 1 (immediately after the intervention, same study visit)
|
|
Post-intervention Amsterdam Preoperative Anxiety and Information Scale (APAIS) score (between groups)
Time Frame: Day 1 (immediately after the intervention, same study visit)
|
Total Amsterdam Preoperative Anxiety and Information Scale (APAIS) score after the intervention, compared between groups.
Scores range from a minimum of 6 to a maximum of 30.
Higher scores indicate a worse outcome (greater anxiety and information need).
|
Day 1 (immediately after the intervention, same study visit)
|
|
Participant satisfaction
Time Frame: Day 1 (immediately after the intervention, same study visit)
|
Participant satisfaction was measured with a 5-item investigator-developed Satisfaction and Perceived Benefit Questionnaire, each item rated on a 5-point Likert scale, summed to a total score.
Scores range from a minimum of 5 to a maximum of 25.
Higher scores indicate a better outcome (greater satisfaction and perceived benefit).
|
Day 1 (immediately after the intervention, same study visit)
|
|
Preferred information modality
Time Frame: Day 1 (immediately after interventions and cross-over exposure to both formats, same study visit)
|
Preferred information modality for future preoperative education, reported by participants after cross-over exposure to both formats immediately after the questionairre.
This is a categorical outcome (video only / written only / both / no preference), not a scored scale; therefore minimum and maximum values are not applicable.
|
Day 1 (immediately after interventions and cross-over exposure to both formats, same study visit)
|
|
Understandability of the educational materials, assessed with the Patient Education Materials Assessment Tool (PEMAT) score
Time Frame: Baseline (educational materials assessed prior to participant enrollment)
|
Understandability of the educational materials, assessed with the Patient Education Materials Assessment Tool (PEMAT): the PEMAT for Audiovisual materials (PEMAT-A/V) for the animated video and the PEMAT for Printable materials (PEMAT-P) for the written leaflet.
The understandability score is expressed as a percentage, ranging from a minimum of 0% to a maximum of 100%.
Higher percentages indicate a better outcome (greater understandability).
|
Baseline (educational materials assessed prior to participant enrollment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammed E Polat, Dr., Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2026
Primary Completion (Actual)
May 15, 2026
Study Completion (Actual)
May 17, 2026
Study Registration Dates
First Submitted
June 10, 2026
First Submitted That Met QC Criteria
June 13, 2026
First Posted (Actual)
June 16, 2026
Study Record Updates
Last Update Posted (Actual)
June 16, 2026
Last Update Submitted That Met QC Criteria
June 13, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TABED 2-25-1755
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The de-identified participant data are available from the corresponding author on reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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