- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07651384
Animated Video Versus Written Leaflet for Preoperative Kidney Transplant Education
13. juni 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
130
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent City Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in procedural knowledge
Tidsramme: 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.
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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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Post-intervention knowledge score (between groups)
Tidsramme: Day 1 (immediately after the intervention, same study visit)
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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)
Tidsramme: 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
Tidsramme: Day 1 (immediately after the intervention, same study visit)
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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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Muhammed E Polat, Dr., Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. januar 2026
Primær færdiggørelse (Faktiske)
15. maj 2026
Studieafslutning (Faktiske)
17. maj 2026
Datoer for studieregistrering
Først indsendt
10. juni 2026
Først indsendt, der opfyldte QC-kriterier
13. juni 2026
Først opslået (Faktiske)
16. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- TABED 2-25-1755
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
The de-identified participant data are available from the corresponding author on reasonable request.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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