UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058941 |
|---|---|
| Receipt number | R000067204 |
| Scientific Title | Factors Affecting the Quality of Life of Children with Pediatric Epilepsy: Focusing on Caregivers' Parenting Attitudes and Children's Illness Acceptance |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/30 21:57:41 |
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Basic information
Public title
Factors Affecting the Quality of Life of Children with Pediatric Epilepsy: Focusing on Caregivers' Parenting Attitudes and Children's Illness Acceptance
Acronym
Factors Affecting the Quality of Life of Children with Pediatric Epilepsy: Focusing on Caregivers' Parenting Attitudes and Children's Illness Acceptance
Scientific Title
Factors Affecting the Quality of Life of Children with Pediatric Epilepsy: Focusing on Caregivers' Parenting Attitudes and Children's Illness Acceptance
Scientific Title:Acronym
Factors Affecting the Quality of Life of Children with Pediatric Epilepsy: Focusing on Caregivers' Parenting Attitudes and Children's Illness Acceptance
Region
| Japan |
Condition
Condition
Pediatric epilepsy
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of caregivers' parenting attitudes and children's illness acceptance on the quality of life of school-aged children with pediatric epilepsy.
Basic objectives2
Others
Basic objectives -Others
To identify factors that improve and promote the quality of life (QOL) of children with epilepsy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Shortened Version of QOL Questionnaire QOLCE-J in Childhood Epilepsy (QOLCE-Js52)
Source: Moriguchi E., Nagai T., Ito M. (2019). Verification of the reliability and validity of the Quality of Life in Childhood Epilepsy Questionnaire QOLCE-Js52. Journal of the Japan Epilepsy Society, 37(2), 606.
Key secondary outcomes
Positive and Negative Parenting Scale (PNPS)
Source: PNPS Test Paper "Standard Edition" (Kaneko Shobo Co., Ltd.)
Likert Scale for Illness Acceptance in Children with Epilepsy
Face Sheet: Caregiver Characteristics (Gender, Age), Child Characteristics (Gender, Age, Age at Onset)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The child has been diagnosed with pediatric epilepsy and is currently undergoing treatment at the University of Tsukuba Hospital.
2.The caregiver is able to assess the child's quality of life (QOL) from the parent's perspective, regardless of the severity of the condition.
3.Informed consent can be obtained in writing for participation in the study.
Key exclusion criteria
1.Caregivers of children with diseases other than pediatric epilepsy.
2.When caregivers have been diagnosed with mental illness or intellectual disability and are deemed unable to assess the QOL of children with pediatric epilepsy.
3.When caregivers have difficulty communicating in Japanese.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Wakimizu |
Organization
University of Tsukuba
Division name
Department of Child Health and Development Nursing, Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3427
riewaki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Hata |
Organization
University of Tsukuba
Division name
School of Medicine and Health Sciences College of Nursing
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3427
Homepage URL
s2312504@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Misaki Hata
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, research subjects will be selected at the trial sites, and a questionnaire survey including primary and secondary outcome measures will be conducted.
Management information
Registered date
| 2025 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067204
