- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07651384
Animated Video Versus Written Leaflet for Preoperative Kidney Transplant Education
13 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
130
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Ankara, Turkiet (Türkiye), 06800
- Ankara Bilkent City Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Video group
Standard verbal counselling plus an animated educational video.
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Approximately 2.5-minute animation depicting the kidney transplant surgical pathway
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Aktiv komparator: Written group
Standard verbal counselling plus a content-matched written information leaflet.
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Illustrated A4 leaflet with content identical to the video.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in procedural knowledge
Tidsram: 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)
|
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Change in preoperative anxiety with the Amsterdam Preoperative Anxiety and Information Scale (APAIS) score
Tidsram: 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.
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Day 1 (immediately before and immediately after the intervention, same study visit)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post-intervention knowledge score (between groups)
Tidsram: 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).
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Day 1 (immediately after the intervention, same study visit)
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Post-intervention Amsterdam Preoperative Anxiety and Information Scale (APAIS) score (between groups)
Tidsram: 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
Tidsram: 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).
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Day 1 (immediately after the intervention, same study visit)
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Preferred information modality
Tidsram: Day 1 (immediately after interventions and cross-over exposure to both formats, same study visit)
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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.
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Day 1 (immediately after interventions and cross-over exposure to both formats, same study visit)
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Understandability of the educational materials, assessed with the Patient Education Materials Assessment Tool (PEMAT) score
Tidsram: Baseline (educational materials assessed prior to participant enrollment)
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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).
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Baseline (educational materials assessed prior to participant enrollment)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Muhammed E Polat, Dr., Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 januari 2026
Primärt slutförande (Faktisk)
15 maj 2026
Avslutad studie (Faktisk)
17 maj 2026
Studieregistreringsdatum
Först inskickad
10 juni 2026
Först inskickad som uppfyllde QC-kriterierna
13 juni 2026
Första postat (Faktisk)
16 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- TABED 2-25-1755
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
The de-identified participant data are available from the corresponding author on reasonable request.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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