RadiotherapyNCT07550686
Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos
A study testing AI-based educational video and Conventional educational video (PPT + narration) in people with Radiotherapy and Patient Education, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiotherapy, Patient Education
- What is being tested?
- AI-based educational video and Conventional educational video (PPT + narration)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2025to 28 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years
- Patients scheduled for radiotherapy
- Ability to watch video and comprehend audio, as assessed by the investigator
- ECOG performance status 0-1
Who cannot join
- Patients unable to complete questionnaires due to cognitive impairment or psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin-si, 365
Hwakyung BYUN, professor, 03151898891, hkbyun05@yuhs.ac
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Radiotherapy, Patient Education
- Being tested
- AI-based educational video, Conventional educational video (PPT + narration)
- Keywords
- Educational Video, Patient Education, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based educational videoOther
Also called Generative AI avatar 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.
Conventional educational video (PPT + narration)Other
Also called Slide-based narrated video
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-based Avatar Video | Experimental | 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. Receives: Other: AI-based educational video |
| PPT + Voice Narration Video | Active comparator | 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. Receives: Other: Conventional educational video (PPT + narration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1(Immediately after the intervention /during the pre-treatment consultation visit)
Secondary outcomes (4)
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.
Measured: T1(Immediately after the intervention (during the pre-treatment consultation visit)
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.
Measured: T2(During the first week of treatment)
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.
Measured: T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)
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.
Measured: T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Dec 2025
- Primary completion28 May 2027 (estimated)
- Study completion28 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either a generative AI-based avatar educational video or a conventional PowerPoint-based video with voice narration.
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital
- Responsible party
- Principal investigator, Hwa Kyung Byun, Yonsei University
- Investigators
- Hwakyung Byun, MD,PhD, Principal investigator, ongin Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550686
- Sponsor's protocol ID
- 9-2025-0190
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Understanding and Anxiety According to the Delivery Method of Educational Videos: A Prospective Randomized Study in Radiotherapy Patients
- ClinicalTrials.gov ID
- NCT07550686
- Acronym / sponsor ID
- 9-2025-0190
- Conditions
- Radiotherapy, Patient Education
- Keywords
- Educational Video, Patient Education, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Severance Hospital
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 28 May 2027 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to receive either a generative AI-based avatar educational video or a conventional PowerPoint-based video with voice narration.
| Arm | Type | Receives |
|---|---|---|
| AI-based Avatar Video | Experimental | Other: AI-based educational videoDescription: 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. |
| PPT + Voice Narration Video | Active comparator | Other: Conventional educational video (PPT + narration)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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 20 years
- Patients scheduled for radiotherapy
- Ability to watch video and comprehend audio, as assessed by the investigator
- ECOG performance status 0-1
Key exclusion criteria (1 listed)
- Patients unable to complete questionnaires due to cognitive impairment or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based educational videoAlso: Generative AI avatar videoStandardized 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 | AI-based Avatar Video |
| Conventional educational video (PPT + narration)Also: Slide-based narrated video5-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 | PPT + Voice Narration Video |
Primary outcome
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hwakyung Byun, MD,PhD principal investigator
ongin Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based educational video and Conventional educational video (PPT + narration) in people with Radiotherapy and Patient Education, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HwaKyung Byun, MD, PhD (+82-31-5189-8166, hkbyun05@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety score (APAIS) (time frame: T1(Immediately after the intervention /during the pre-treatment consultation visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.