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Recruiting NCT07550686

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

No phase Interventional Radiotherapy Patient Education

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-based educational video, Conventional educational video (PPT + narration).
Who it may be relevant to
Registry conditions: Radiotherapy, Patient Education. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • Anxiety score (APAIS) [Time frame: T1(Immediately after the intervention /during the pre-treatment consultation visit)]
Secondary outcome measures (4)
  • Anxiety level (K-HADS-A) [Time frame: T1(Immediately after the intervention (during the pre-treatment consultation visit)]
  • Anxiety level (APAIS, K-HADS-A) [Time frame: T2(During the first week of treatment)]
  • Knowledge score [Time frame: T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)]
  • Satisfaction score [Time frame: T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

South Korea · 1 center
  • Yongin Severance Hospital — Yongin-si

Identifiers

NCT: NCT07550686 · 9-2025-0190

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗