Kidney Transplantation (Status Post)NCT07651384
Animated Video Versus Written Leaflet for Preoperative Kidney Transplant Education
A study testing Animated educational video and Written information leaflet in people with Kidney Transplantation (Status Post) and Preoperative Anxiety, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation (Status Post), Preoperative Anxiety, Patient Education
- What is being tested?
- Animated educational video and Written information leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 17 May 2026
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Animated educational video, Written information leaflet
- Keywords
- patient education, animated video, informed consent, preoperative anxiety, APAIS, kidney transplantation, living donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated educational videoBehavioural
Approximately 2.5-minute animation depicting the kidney transplant surgical pathway
Written information leafletBehavioural
Illustrated A4 leaflet with content identical to the video.
| Study group | Role | What they receive |
|---|---|---|
| Video group | Experimental | Standard verbal counselling plus an animated educational video. Receives: Behavioral: Animated educational video |
| Written group | Active comparator | Standard verbal counselling plus a content-matched written information leaflet. Receives: Behavioral: Written information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in procedural knowledge
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.
Measured: 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
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.
Measured: Day 1 (immediately before and immediately after the intervention, same study visit)
Secondary outcomes (5)
Post-intervention knowledge score (between groups)
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).
Measured: Day 1 (immediately after the intervention, same study visit)
Post-intervention Amsterdam Preoperative Anxiety and Information Scale (APAIS) score (between groups)
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).
Measured: Day 1 (immediately after the intervention, same study visit)
Participant satisfaction
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).
Measured: Day 1 (immediately after the intervention, same study visit)
Preferred information modality
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.
Measured: 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
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).
Measured: Baseline (educational materials assessed prior to participant enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start2 Jan 2026
- Primary completion15 May 2026
- Study completion17 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplantation (Status Post)Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Emin Polat, Ankara City Hospital Bilkent
- Investigators
- Muhammed E Polat, Dr., Principal investigator, Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651384
- Sponsor's protocol ID
- TABED 2-25-1755
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The de-identified participant data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Animated Video and Written Information on Understanding, Knowledge Level, and Anxiety in Explaining Kidney Transplant Surgery to Patients
- ClinicalTrials.gov ID
- NCT07651384
- Acronym / sponsor ID
- TABED 2-25-1755
- Keywords
- patient education, animated video, informed consent, preoperative anxiety, APAIS, kidney transplantation, living donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 16 Jun 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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video group | Experimental | Behavioral: Animated educational videoStandard verbal counselling plus an animated educational video. |
| Written group | Active comparator | Behavioral: Written information leafletStandard verbal counselling plus a content-matched written information leaflet. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Animated educational videoApproximately 2.5-minute animation depicting the kidney transplant surgical pathway | Behavioural | Video group |
| Written information leafletIllustrated A4 leaflet with content identical to the video. | Behavioural | Written group |
Primary outcome
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.
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.
5 secondary outcomes
Post-intervention knowledge score (between groups)
Time frame: 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)
Participant satisfaction
Time frame: 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)
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)
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 16 Jun 2026.
- Individual participant dataSharing planned: No. The de-identified participant data are available from the corresponding author on reasonable request.
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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.
Muhammed E Polat, Dr. principal investigator
Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animated educational video and Written information leaflet in people with Kidney Transplantation (Status Post) and Preoperative Anxiety, run by Ankara City Hospital Bilkent 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 4 inclusion and 4 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 16 Jun 2026. 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?
Change in procedural knowledge (time frame: Day 1 (immediately before and immediately after the intervention, same study visit)). 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 16 Jun 2026.