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临床试验/NCT07651384
NCT07651384已完成不适用

Comparing the Effects of Animated Video and Written Information on Understanding, Knowledge Level, and Anxiety in Explaining Kidney Transplant Surgery to Patients

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Change in procedural knowledge

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Video group

Experimental

Standard verbal counselling plus an animated educational video.

干预措施: Animated educational video (Behavioral)

Written group

Active Comparator

Standard verbal counselling plus a content-matched written information leaflet.

干预措施: Written information leaflet (Behavioral)

结局指标

主要结局

Change in procedural knowledge

时间窗: 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

时间窗: 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.

次要结局

  • Post-intervention knowledge score (between groups)(Day 1 (immediately after the intervention, same study visit))
  • Post-intervention Amsterdam Preoperative Anxiety and Information Scale (APAIS) score (between groups)(Day 1 (immediately after the intervention, same study visit))
  • Participant satisfaction(Day 1 (immediately after the intervention, same study visit))
  • Preferred information modality(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(Baseline (educational materials assessed prior to participant enrollment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Emin Polat

Urology Specialist

Ankara City Hospital Bilkent

研究点 (1)

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