UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063039 |
|---|---|
| Receipt number | R000072162 |
| Scientific Title | Participatory skit based education for Opisthorchis viverrini prevention among schoolchildren in southern Lao PDR an uncontrolled pre post intervention study |
| Date of disclosure of the study information | 2026/09/24 |
| Last modified on | 2026/09/24 14:56:12 |
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Basic information
Public title
Participatory skit-based education for Opisthorchis viverrini prevention among schoolchildren in southern Lao PDR
Acronym
Participatory skit-based education for Opisthorchis viverrini prevention among schoolchildren in southern Lao PDR
Scientific Title
Participatory skit based education for Opisthorchis viverrini prevention among schoolchildren in southern Lao PDR an uncontrolled pre post intervention study
Scientific Title:Acronym
Participatory skit-based education for Opisthorchis viverrini prevention among schoolchildren in southern Lao PDR
Region
| Asia(except Japan) |
Condition
Condition
Opisthorchis viverrini infection (opisthorchiasis)
Classification by specialty
| Infectious disease | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a short participatory school-based educational intervention for Opisthorchis viverrini (OV) prevention among primary and lower-secondary school students in southern Lao PDR by examining short-term changes in OV-related knowledge and attitudes, students' perceptions of a participatory skit-based activity, and practical challenges in implementing the intervention.
Basic objectives2
Others
Basic objectives -Others
Feasibility and short-term educational effects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Opisthorchis viverrini related knowledge and attitudes measured using self administered questionnaires immediately before and after each educational training session.OV related knowledge was assessed using true or false items covering transmission, prevention, the transmission cycle, animal reservoirs, common misconceptions, deworming, severe disease, and risks associated with early initiation of raw fish consumption. Attitudes and perceptions related to OV prevention were assessed using five point Likert scale items.
Key secondary outcomes
Key secondary outcomes
Perceived importance of OV prevention education.
Willingness to engage in OV prevention education.
Perceived adequacy of knowledge for providing OV prevention education.
Confidence in providing OV prevention education.
Students' perceptions of the skit-based activity, including their perceived ability to create an OV prevention skit, perceived effectiveness of skits for prevention education, contribution to skit development, and enjoyment of the activity.
Practical implementation challenges observed during the participatory skit-development activities.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants received a two session school based educational intervention on Opisthorchis viverrini (OV) prevention. Each session lasted approximately 3 hours. During the first session, district education and health staff provided basic information about OV, including routes of transmission, symptoms, and preventive measures. During the second session, students participated in a group based activity to develop short skits communicating key messages about OV prevention. Before developing the skits, facilitators demonstrated a model skit and reviewed core OV prevention messages. Students then developed a scenario, assigned roles, rehearsed their performance, and presented the skits to other participants. Teachers from the participating schools and staff from district health or education offices served as facilitators.
Interventions/Control_2
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
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students enrolled in Grades 4 or 5 of the participating primary schools or Grades 1to 3 of the participating lower secondary schools.
Students able to participate in both educational training sessions.
Students with sufficient literacy skills to read and complete the questionnaire and training materials.
Students able to participate in group based activities.
Students recommended by teachers as having the ability to participate actively in the training activities.
Students whose parents or guardians permitted their participation through the participating schools and who did not decline participation themselves.
Key exclusion criteria
Students unable to participate in both training sessions.
Students unable to read or complete the study questionnaire and training materials.
Students unable to participate in the group activities.
Students who declined participation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sachi |
| Middle name | Miyake (Tomokawa |
| Last name | Tomokawa |
Organization
Shinshu University
Division name
Faculty of Education
Zip code
3808544
Address
6ro nishi-nagano, nagano city
TEL
+81-26-2384167
sachitjp@hotmail.com
Public contact
Name of contact person
| 1st name | Sachi |
| Middle name | Miyake (Tomokawa |
| Last name | Tomokawa |
Organization
Shinshu University
Division name
Faculty of Education
Zip code
3808544
Address
6-ro nishi-nagano, nagano city
TEL
08019336341
Homepage URL
sachitjp@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
AMED
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
6-ro nishi-nagano, nagano city
Tel
81262384167
sachitjp@hotmail.com
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
| 2026 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072162
