- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07651384
Animated Video Versus Written Leaflet for Preoperative Kidney Transplant Education
13 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
130
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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Ankara, Turchia (Türkiye), 06800
- Ankara Bilkent City Hospital
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Video group
Standard verbal counselling plus an animated educational video.
|
Approximately 2.5-minute animation depicting the kidney transplant surgical pathway
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in procedural knowledge
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Post-intervention knowledge score (between groups)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Muhammed E Polat, Dr., Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 gennaio 2026
Completamento primario (Effettivo)
15 maggio 2026
Completamento dello studio (Effettivo)
17 maggio 2026
Date di iscrizione allo studio
Primo inviato
10 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 giugno 2026
Primo Inserito (Effettivo)
16 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
16 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- TABED 2-25-1755
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
The de-identified participant data are available from the corresponding author on reasonable request.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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