UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054020 |
|---|---|
| Receipt number | R000061668 |
| Scientific Title | A Study of the burden on guardians of children with medical necessities |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/04/01 17:02:33 |
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Basic information
Public title
A Study of the burden on guardians of children with medical necessities
Acronym
A Study of the burden on guardians of children with medical necessities
Scientific Title
A Study of the burden on guardians of children with medical necessities
Scientific Title:Acronym
A Study of the burden on guardians of children with medical necessities
Region
| Japan |
Condition
Condition
A Study of the burden on guardians of children with medical necessities
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on the daily lives of parents with children in medical care, we will clarify whether the use of frequently used medical tape decorated with characters and other products changes the burden on parents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conducting a questionnaire survey by mail regarding the current state of mind of parents with children in medical care.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Conducting a questionnaire survey to investigate the state of mind of parents who have children in medical care.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parents (18 to 60 years old) of children under medical care (0 to 18 years old)
Key exclusion criteria
The outline of the survey will be explained in advance, and those who cannot consent will be excluded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | miki |
| Middle name | |
| Last name | oya |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Social Welfare Department of Social Welfare
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252574470
miki-oya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | miki |
| Middle name | |
| Last name | oya |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Social Welfare Department of Social Welfare
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252574470
Homepage URL
miki-oya@nuhw.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
Tel
0252574470
miki-oya@nuhw.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 | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061668
