UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054107 |
|---|---|
| Receipt number | R000061791 |
| Scientific Title | A trial to evaluate the feasibility of using radio-controlled miniature cars to reduce preoperative anxiety in children. |
| Date of disclosure of the study information | 2024/04/13 |
| Last modified on | 2024/04/10 14:51:57 |
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Basic information
Public title
A trial to evaluate the feasibility of using radio-controlled miniature cars to reduce preoperative anxiety in children.
Acronym
A trial to evaluate the feasibility of using radio-controlled miniature cars to reduce preoperative anxiety in children.
Scientific Title
A trial to evaluate the feasibility of using radio-controlled miniature cars to reduce preoperative anxiety in children.
Scientific Title:Acronym
A trial to evaluate the feasibility of using radio-controlled miniature cars to reduce preoperative anxiety in children.
Region
| Japan |
Condition
Condition
The disease requiring surgery corresponds to one of the following: inguinal hernia, undescended testis, ectopic testis, hydrocele, neuroblastoma, hepatoblastoma, nephroblastoma, teratoma, choledochal cyst, biliary atresia, urachal anomaly, phimosis, or paraurethral cyst.Examining the safety and feasibility of a service using RC mini-cars to alleviate children's pre-operative anxiety
Classification by specialty
| Surgery in general | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the safety and feasibility of a service using RC mini-cars to alleviate children's pre-operative anxiety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events associated with entering the operating room in RC mini-cars.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Entering the operating room using RC mini-cars
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
| 4 | years-old | <= |
Age-upper limit
| 7 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients undergoing surgery at Department of Pediatric Surgery, Kyushu University between the approval date and March 31, 2025.
(2) Patients with a diagnosis corresponding to one of the following: inguinal hernia, undescended testis, ectopic testis, hydrocele, neuroblastoma, hepatoblastoma, nephroblastoma, teratoma, choledochal cyst, biliary atresia, urachal anomaly, phimosis, or paraurethral cyst.
(3) Patients who fully understand entering the operating room riding an RC mini-car, and whose guardians fully understand this research plan, with consent obtainable from the patient (or guardian).
(4) Patients aged 4 to 7 years at the time of consent acquisition.
Key exclusion criteria
(1) Performance States below 80 (Lansky score)
(2) Patients who cannot ride an RC mini-car (those who routinely require a wheelchair, have developmental delays, cannot maintain a seated position due to severe inflammation or pain, or have conditions requiring emergency surgery)
(3) Other patients deemed inappropriate as study subjects by the researchers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naonori |
| Middle name | |
| Last name | Kawakubo |
Organization
Kyushu University Faculty of Medical Sciences
Division name
Pediatric Surgery
Zip code
812-8582
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
+81-92-642-5573
kawakubo.naonori.061@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Naonori |
| Middle name | |
| Last name | Kawakubo |
Organization
Kyushu University Faculty of Medical Sciences
Division name
Pediatric Surgery
Zip code
812-8582
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
+81-92-642-5573
Homepage URL
kawakubo.naonori.061@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu 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
Institutional Review Board for Clinical Trials (Intervention Studies)
Address
3-1-1, Maidashi, Higashiku, Fukuoka
Tel
+81-92-642-5082
byskenkyu@jimu.kyushu-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 | 04 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 20 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061791
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
