UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053220 |
|---|---|
| Receipt number | R000060739 |
| Scientific Title | Hand hygiene, oral hygiene practice and health condition before and after hygiene education to primary school children in Pyuthan, Nepal |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2023/12/26 06:18:02 |
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Basic information
Public title
Hand hygiene, oral hygiene practice and health condition before and after hygiene education to primary school children in Pyuthan, Nepal
Acronym
Hand hygiene, oral hygiene practice and health condition before and after hygiene education to primary school children in Pyuthan, Nepal
Scientific Title
Hand hygiene, oral hygiene practice and health condition before and after hygiene education to primary school children in Pyuthan, Nepal
Scientific Title:Acronym
Hand hygiene, oral hygiene practice and health condition before and after hygiene education to primary school children in Pyuthan, Nepal
Region
| Japan | Asia(except Japan) |
Condition
Condition
The subjects are 267 children attending 4 primary schools in Pyuthan. (Shree Shidhyashory Primary School, Baljyoti Primary School, Dipendra Primary School, Nepal National Primary School)
Classification by specialty
| Dental medicine | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this research is to clarify hand and oral hygiene practices of primary school children in Pyuthan, a rural area of Nepal and to consider the effect of hygiene education provided.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After hygiene education whether the number of children performing hand hygiene behaviors after hygiene education has increased, whether the number of children performing oral hygiene behaviors has increased, whether oral conditions have improved (caries, gums, plaque status, tooth pain and discomfort), whether eating behaviors have improved, whether the number of common cold symptoms and days absent due to illness have decreased (1 year and 2 years after hygiene education)
Key secondary outcomes
Whether more frequent hand hygiene behaviors are associated with fewer common cold symptoms and fewer days absent from school due to illness
Whether more frequent oral hygiene behaviors are associated with fewer common cold symptoms and fewer days absent from school due to illness
Whether good oral health is associated with fewer common cold symptoms and fewer days absent from school due to illness
Whether better dietary behavior is associated with fewer common cold symptoms and fewer days absent from school due to illness
Whether underweight or obesity is associated with fewer common cold symptoms and fewer days absent due to illness
Whether more frequent oral hygiene behaviors are associated with better oral health
Whether more frequent oral hygiene behaviors are associated with less dental pain and discomfort
Whether good oral condition is associated with less underweight or obesity
Whether good eating behavior is associated with good oral health,
Whether eating behavior is associated with low body weight and obesity
father's and mother's level of education is associated with hand hygiene and oral hygiene behaviors, oral condition, eating behavior, and low body weight and obesity
(before hygiene education)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Hand Hygiene education, Oral Hygiene education
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
| 3 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ask elementary school students participating in the Rural Kids Help Project to cooperate.
Key exclusion criteria
No exclusion criteria.
Target sample size
267
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Kondo |
Organization
Tokyo Medical and Dental University
Division name
International Nursing Development, Graduate School of Health Care Sciences
Zip code
1138519
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0358035387
akondo.ind@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kondo |
Organization
Tokyo Medical and Dental University
Division name
International Nursing Development, Graduate School of Health Care Sciences
Zip code
1138519
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0358035387
Homepage URL
akondo.ind@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku Tokyo
Tel
0358035387
akondo.ind@tmd.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
| 2024 | Year | 01 | Month | 31 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060739
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