- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550686
Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos
Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos: A Prospective Randomized Study in Radiotherapy Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HwaKyung Byun, MD, PhD
- Phone Number: +82-31-5189-8166
- Email: hkbyun05@yuhs.ac
Study Locations
-
-
-
Yongin-si, South Korea, 365
- Recruiting
- Yongin Severance Hospital
-
Contact:
- Hwakyung BYUN, professor
- Phone Number: 03151898891
- Email: hkbyun05@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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 Names:
|
|
Active Comparator: 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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety score (APAIS)
Time Frame: T1(Immediately after the intervention /during the pre-treatment consultation visit)
|
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.
|
T1(Immediately after the intervention /during the pre-treatment consultation visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety level (K-HADS-A)
Time Frame: T1(Immediately after the intervention (during the pre-treatment consultation visit)
|
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.
|
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)
|
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. |
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)
|
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.
|
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)
|
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. |
T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hwakyung Byun, MD,PhD, ongin Severance Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 9-2025-0190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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