UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056879 |
|---|---|
| Receipt number | R000065009 |
| Scientific Title | Examining the effectiveness of HPV (Human Papilloma Virus) vaccine education using an Escape Room. |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2026/05/01 15:19:12 |
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Basic information
Public title
Examining the effectiveness of HPV (Human Papilloma Virus) vaccine education using an Escape Room
Acronym
Examining the effectiveness of vaccine education using an Escape Room
Scientific Title
Examining the effectiveness of HPV (Human Papilloma Virus) vaccine education using an Escape Room.
Scientific Title:Acronym
Examining the effectiveness of vaccine education using an Escape Room
Region
| Japan |
Condition
Condition
Cervical cancer,HPV infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Escape Room (ER), first introduced as an entertainment activity in Kyoto, Japan, in 2007, is a team-based game in which participants solve themed puzzles, riddles, and other tasks to achieve a specific goal, such as escaping from one or more rooms within a time limit. In Japan, many events are held primarily in urban centers, and dedicated facilities exist for ER experiences. Additionally, ER events featuring collaborations with popular anime, games, and films are especially popular among young people. Similarly, ERs have become a major form of entertainment in tourist destinations worldwide.
In recent years, ERs have been increasingly utilized as an educational strategy across various fields, with numerous reports highlighting their application in medical education both in Japan and abroad. However, most studies evaluating the educational use of ERs focus on Level 1: Reaction of the Kirkpatrick model, while few have assessed learning outcomes at Level 2: Learning or Level 3: Behavior. Therefore, this study aims to compare the educational effectiveness of an ER-based activity on the topic of the HPV vaccine with a traditional lecture-based approach and a control group, all within the same allotted time frame.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the percentage of correct responses to the post-class and three-month post-class verification tests.
Secondary outcomes are post-class vaccination coverage, participant satisfaction and comprehension.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
HPV vaccine education using Escape Room.
Interventions/Control_2
teaching HPV vaccine by a teacher
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The study was conducted at a single centre at Kyoritsu Women's University in Japan. The study population was 300 biological women. Faculty and age were not specified. Those who agreed to participate in the study were selected based on the free will of the study subjects.
Key exclusion criteria
Those who were deemed unsuitable as research subjects by the principal investigator and those who had once participated in this study were excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Kondo |
Organization
Juntendo University School of Medicine
Division name
department of general medicine
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
k.kondo.ea@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Kondo |
Organization
Juntendo University School of Medicine
Division name
department of general medicine
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
k.kondo.ea@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Ethics Committee, Faculty of Medicine, Juntendo University School of Medicine
Address
Centre for Clinical Research and Clinical Trials, Juntendo University Hospital, 3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3814-5672
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
No publicly accessible external protocol URL is available at present.
Publication of results
Unpublished
Result
URL related to results and publications
No publicly accessible external results URL is available at present.
Number of participants that the trial has enrolled
271
Results
Among 267 participants (escape room, n=92; lecture, n=75; control, n=100), the lecture group showed the greatest immediate improvement in knowledge and vaccination intention. At 3 months, both intervention groups retained higher knowledge than the control group, with no difference between the escape room and lecture groups. Among baseline-unvaccinated participants, intention increased more in the escape room group, while vaccination initiation was higher in the lecture group.
Results date posted
| 2026 | Year | 03 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 18 | Day |
Baseline Characteristics
A total of 267 students were enrolled: 92 in the escape room group, 75 in the lecture group, and 100 in the control group. No participants were excluded. At the 3-month follow-up, responses were obtained from 89, 69, and 67 participants, respectively. Baseline characteristics differed among groups, with the control group showing a lower proportion of participants with a history of HPV vaccination than the two intervention groups.
Participant flow
Biologically female students at Kyoritsu Women's University were recruited through on-campus announcements and participated voluntarily after providing written informed consent. Student identification numbers were used to prevent duplicate participation, and participants could withdraw at any time. Group allocation was not randomized; participants were assigned based on attendance at one of the scheduled sessions. Group A (escape room group) attended a 30-minute session on September 24, 2024; Group B (lecture group) attended a 30-minute lecture session on September 26, 2024; and Group C (control group) attended on September 26, 2024 and received no educational intervention. Groups A and B completed questionnaires at baseline, immediately after the class, and 3 months after the class, while Group C completed questionnaires at baseline and 3 months only.
Adverse events
No adverse events related to the study interventions were reported during the study period.
Outcome measures
Outcome measures
Primary outcome measures
HPV-related knowledge score (7-item multiple-choice test; assessed at baseline, immediately post-class, and 3 months post-class in the escape room and lecture groups; baseline and 3 months in the control group).
Intention to receive HPV vaccination among participants unvaccinated at baseline (0 doses), assessed using a 7-point Likert scale at the same time points.
Secondary outcome measures
Vaccination initiation within 3 months among participants unvaccinated at baseline (0 doses), defined as self-reported receipt of at least one dose of HPV vaccine.
Satisfaction with the class, assessed immediately post-class in the escape room and lecture groups using a 10-point Likert scale.
Perceived comprehension, assessed immediately post-class in the escape room and lecture groups using a 10-point Likert scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 18 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 18 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065009
