Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 20 years
Patients scheduled for radiotherapy
Ability to watch video and comprehend audio, as assessed by the investigator
ECOG performance status 0-1
Disqualifiers
Patients unable to complete questionnaires due to cognitive impairment or psychiatric disorders
Trial design
Design model
Parallel
Treatments tested in this trial
AI-based educational video
Other interventionStandardized 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.
Conventional educational video (PPT + narration)
Other intervention5-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.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: AI-based Avatar VideoExperimental treatment 1 intervention
Group B: PPT + Voice Narration VideoActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety score (APAIS)
Anxiety will be measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (total score range: 6-30; higher scores indicate greater anxiety). Change from baseline will be analyzed using a linear mixed model.
Time frame
T1(Immediately after the intervention /during the pre-treatment consultation visit)Secondary outcomes
1
Anxiety level (K-HADS-A)
Anxiety will be measured using the Korean version of the Hospital Anxiety and Depression Scale - Anxiety subscale (K-HADS-A) (score range: 0-21; higher scores indicate greater anxiety). Change from baseline will be analyzed using a linear mixed model.
Time frame
T1(Immediately after the intervention (during the pre-treatment consultation visit)2
Anxiety level (APAIS, K-HADS-A)
Anxiety will be measured using both APAIS an d K-HADS-A during the first week of treatment. Baseline scores assessed Anxiety will be measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (6-30; higher = greater anxiety) and the Korean version of the Hospital Anxiety and Depression Scale - Anxiety subscale (K-HADS-A) (0-21; higher = greater anxiety). Change from baseline will be analyzed using a linear mixed model.
Time frame
T2(During the first week of treatment)3
Knowledge score
Knowledge will be assessed using a structured questionnaire (score range: 0-10; higher scores indicate better knowledge). Change from baseline will be analyzed using a linear mixed model.
Time frame
T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)4
Satisfaction score
Participant satisfaction with the educational intervention will be assessed Satisfaction will be assessed using a standardized questionnaire (score range: 0-10; higher scores indicate greater satisfaction). Change over time will be analyzed using a linear mixed model.
Time frame
T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)Sponsors and contacts
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Yonsei University
Lead sponsor
Severance Hospital
Collaborator
Source ClinicalTrials.gov