- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07651384
Animated Video Versus Written Leaflet for Preoperative Kidney Transplant Education
13 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
130
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ankara, Turquia (Türkiye), 06800
- Ankara Bilkent City Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in procedural knowledge
Prazo: Day 1 (immediately before and immediately after the intervention, same study visit)
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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)
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Change in preoperative anxiety with the Amsterdam Preoperative Anxiety and Information Scale (APAIS) score
Prazo: Day 1 (immediately before and immediately after the intervention, same study visit)
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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)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Post-intervention knowledge score (between groups)
Prazo: 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)
Prazo: Day 1 (immediately after the intervention, same study visit)
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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).
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Day 1 (immediately after the intervention, same study visit)
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Participant satisfaction
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Muhammed E Polat, Dr., Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de janeiro de 2026
Conclusão Primária (Real)
15 de maio de 2026
Conclusão do estudo (Real)
17 de maio de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
10 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de junho de 2026
Primeira postagem (Real)
16 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- TABED 2-25-1755
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
The de-identified participant data are available from the corresponding author on reasonable request.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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