Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos: A Prospective Randomized Study in Radiotherapy Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Anxiety score (APAIS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study in which participants and investigators are aware of the assigned intervention due to the nature of the educational video formats.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 20 years
- •Patients scheduled for radiotherapy
- •Ability to watch video and comprehend audio, as assessed by the investigator
- •ECOG performance status 0-1
排除标准
- •Patients unable to complete questionnaires due to cognitive impairment or psychiatric disorders
研究组 & 干预措施
AI-based Avatar Video
Description:
Participants will watch a generative AI-based educational video delivered through an avatar format. The video explains radiotherapy procedures, expected side effects, and self-care information. Duration is approximately 5 minutes.
Intervention Type: Other Intervention Name: AI-based educational video
Intervention Description:
A standardized educational video generated using artificial intelligence avatar technology, designed to improve patient understanding and reduce anxiety prior to radiotherapy.
干预措施: AI-based educational video (Other)
PPT + Voice Narration Video
Description:
Participants will watch a conventional educational video consisting of PowerPoint slides with voice narration. Content, duration (~5 minutes), and key messages are equivalent to the experimental arm.
Intervention Type: Other Intervention Name: Conventional educational video (PPT + narration)
Intervention Description:
A traditional educational video using slide-based presentation with voice narration covering radiotherapy-related information.
干预措施: Conventional educational video (PPT + narration) (Other)
结局指标
主要结局
Anxiety score (APAIS)
时间窗: T1(Immediately after the intervention /during the pre-treatment consultation visit)
Participants' anxiety will be measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) immediately after the intervention. Baseline anxiety scores will serve as reference values. Changes from baseline will be analyzed using a linear mixed model.
次要结局
- Anxiety level (K-HADS-A)(T1(Immediately after the intervention (during the pre-treatment consultation visit))
- Knowledge score(T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment))
- Anxiety level (APAIS, K-HADS-A)(T2(During the first week of treatment))
- Satisfaction score(T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment))
研究者
Hwa Kyung Byun
Assistant Professor
Yonsei University