UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056457 |
|---|---|
| Receipt number | R000063353 |
| Scientific Title | Effects of an educational intervention of home treatment on parental anxiety related to the onset of symptoms of acute illness in preschool children: a randomized controlled trial. |
| Date of disclosure of the study information | 2024/12/13 |
| Last modified on | 2024/12/13 20:01:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of home care education for acute symptoms in children: a randomized controlled trial
Acronym
Effectiveness of home care education for acute symptoms in children: a randomized controlled trial
Scientific Title
Effects of an educational intervention of home treatment on parental anxiety related to the onset of symptoms of acute illness in preschool children: a randomized controlled trial.
Scientific Title:Acronym
Effects of an educational intervention of home treatment on parental anxiety related to the onset of symptoms of acute illness in preschool children: a randomized controlled trial.
Region
| Japan |
Condition
Condition
Symptoms of Acute Illness in Children
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of educational interventions for parents against acute illness in their children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent Change in Knowledge Score
Percent change in STAI score
Percent change in self-efficacy score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
electronic document
Interventions/Control_2
video
Interventions/Control_3
control
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Primary caregivers, including parents or relatives, who care for infants under 3 years of age
(ii) A person who is 18 years of age or older at the time of obtaining consent
(iii) A person who can read and write Japanese
(iv) Persons with access to the Internet
(5) Persons who understand the purpose of the research and agree to participate in the research.
Key exclusion criteria
(i) Those with specialized education in medical care or childcare, etc.
(2) Persons with mental illness
(iii) Those whose children have chronic diseases (requiring regular visits to the hospital)
(4) Those whose children have multiple births
(5) Those whose children have low birth weight.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | YUKIKO |
| Middle name | |
| Last name | SATOU |
Organization
Niigata University
Division name
School of Medicine and Health Sciences
Zip code
951-8518
Address
746 Asahimachidori 2-bancho, Chuo-ku, Niigata Cit
TEL
0252270522
y-satoh@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKIKO |
| Middle name | |
| Last name | SATOU |
Organization
Niigata University
Division name
School of Medicine and Health Sciences
Zip code
951-8518
Address
746 Asahimachidori 2-bancho, Chuo-ku, Niigata City
TEL
0252270522
Homepage URL
y-satoh@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
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
Niigata University Ethics Review Committee for Research Involving Human Subjects
Address
754, Asahimachidori 1-bancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-227-2625
ethics@adm.niigata-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 | 12 | Month | 13 | 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
210
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | 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 | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063353
