Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos

Официальное название

Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos: A Prospective Randomized Study in Radiotherapy Patients

Обзор

This study aims to evaluate whether a generative artificial intelligence (AI)-based educational video is more effective than a conventional video in improving patient understanding and reducing anxiety before radiation therapy. In this prospective, randomized controlled study, participants will be assigned in a 1:1 ratio to either an AI-based avatar video group or a conventional video group consisting of PowerPoint slides with voice narration. Both videos will be standardized to have similar duration (approximately 5 minutes), identical key messages, and the same summary points. After providing informed consent, participants will complete questionnaires before and after watching the assigned video, as well as during the first week of treatment. Outcomes will include anxiety levels, knowledge comprehension, and satisfaction with the educational video. A total of 136 patients scheduled to undergo radiation therapy will be enrolled from two institutions. The findings of this study are expected to provide evidence on the effectiveness of AI-based educational tools in enhancing patient education and reducing pre-treatment anxiety.

Подробное описание

This study is a prospective, randomized, parallel-group trial designed to evaluate the effectiveness of a generative artificial intelligence (AI)-based educational video compared with a conventional video in patients undergoing radiation therapy.

Participants will be randomly assigned in a 1:1 ratio to one of two groups: (A) an AI-based avatar video group or (B) a conventional video group consisting of PowerPoint slides with voice narration. Both videos will be standardized to ensure comparable duration (approximately 5 minutes), identical core content, and equivalent summary points to minimize variability in information delivery.

After providing informed consent, participants will be asked to complete structured questionnaires at three time points: before viewing the video (baseline), immediately after viewing the video, and during the first week of radiation therapy. The assessments will include measures of anxiety, knowledge comprehension, and satisfaction with the educational material. Baseline assessments will be used as reference values for evaluating changes over time.

The primary objective is to compare post-intervention anxiety levels between the two groups. Secondary objectives include comparisons of knowledge comprehension, satisfaction with the educational video, and changes in anxiety over time.

Statistical analyses will be performed based on the intention-to-treat principle. Descriptive statistics will be used to summarize baseline characteristics. Changes in outcomes over time and between groups will be analyzed using appropriate statistical models for repeated measures. Missing data will not be imputed; analyses will be conducted using available data for each outcome measure.

This study will be conducted at two institutions and aims to provide evidence on whether AI-based educational tools can improve patient understanding and reduce anxiety in the clinical setting.

Вмешательства

• Другое AI-based educational video
  Standardized 5-minute educational video delivered via AI-generated avatar to explain radiotherapy procedures, expected side effects, and self-care information. Designed to improve patient understanding and reduce anxiety.
• Другое Conventional educational video (PPT + narration)
  5-minute educational video using PowerPoint slides with voice narration covering identical content as the AI-based video, including radiotherapy procedures, side effects, and self-care information.

Первичные конечные точки

• Anxiety score (APAIS) [Срок оценки: T1(Immediately after the intervention /during the pre-treatment consultation visit)]

Вторичные конечные точки (4)

• Anxiety level (K-HADS-A) [Срок оценки: T1(Immediately after the intervention (during the pre-treatment consultation visit)]
• Anxiety level (APAIS, K-HADS-A) [Срок оценки: T2(During the first week of treatment)]
• Knowledge score [Срок оценки: T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)]
• Satisfaction score [Срок оценки: T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)]

Критерии участия

Критерии включения

• Age ≥ 20 years
• Patients scheduled for radiotherapy
• Ability to watch video and comprehend audio, as assessed by the investigator
• ECOG performance status 0-1

Критерии исключения

• Patients unable to complete questionnaires due to cognitive impairment or psychiatric disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 1 центр

• Yongin Severance Hospital — Yongin-si

Идентификаторы

NCT: NCT07550686 · 9-2025-0190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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