UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055693 |
|---|---|
| Receipt number | R000063574 |
| Scientific Title | Effectiveness of provision of disease explanation using visual and experiential tools for children with renal disease (Preparation) |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2024/10/01 18:39:02 |
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Basic information
Public title
Effectiveness of provision of disease explanation using visual and experiential tools for children with renal disease (Preparation)
Acronym
Effectiveness of explanation using visual and experiential tools for children with renal disease (Preparation)
Scientific Title
Effectiveness of provision of disease explanation using visual and experiential tools for children with renal disease (Preparation)
Scientific Title:Acronym
Effectiveness of explanation using visual and experiential tools for children with renal disease (Preparation)
Region
| Japan |
Condition
Condition
Renal disease including glomerular- and renal tubular- disease
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of explanation to children with renal disease using the originally developed visual and experiential tools to promote understanding of the disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.state-trait anxiety inventory for children (STAIC)
2.Face scale
3.GSESC-R
Key secondary outcomes
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
| Other |
Interventions/Control_1
(1) viewing the video about kidney function
(2) experiencing the kidney function by playing with the kidney function model
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
| 5 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Diagnosed with renal disease or congenital renal urinary system malformation.
- Admitted to the Child Health and Development Center or seen at the pediatric outpatient of The Gunma University Hospital
Key exclusion criteria
Patients whose informed consent is not obtained by parents
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Kobayashi |
Organization
Gunma University Hospital
Division name
Department of Pediatrics
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-7111
kobayasu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Kobayashi |
Organization
Gunma University Hospital
Division name
Department of Pediatrics
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-7111
Homepage URL
kobayasu@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University Ethical committee on Medical and Health Research Involving Human Subject
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
hiotaisho-ciru@ml.gunma-u.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 | 10 | Month | 02 | 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
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063574
