NCT07651384

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 10, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

patient educationanimated videoinformed consentpreoperative anxietyAPAISkidney transplantationliving donor

Outcome Measures

Primary Outcomes (2)

  • Change in procedural knowledge

    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

    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)

Secondary Outcomes (5)

  • 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)

Study Arms (2)

Video group

EXPERIMENTAL

Standard verbal counselling plus an animated educational video.

Behavioral: Animated educational video

Written group

ACTIVE COMPARATOR

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

Behavioral: Written information leaflet

Interventions

Approximately 2.5-minute animation depicting the kidney transplant surgical pathway

Video group

Illustrated A4 leaflet with content identical to the video.

Written group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Study Officials

  • Muhammed E Polat, Dr.

    Ankara Bilkent City Hospital ; Department of Urology ; Ankara ; Türkiye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Specialist

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 16, 2026

Study Start

January 2, 2026

Primary Completion

May 15, 2026

Study Completion

May 17, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

The de-identified participant data are available from the corresponding author on reasonable request.

Locations