UMIN ID: UMIN000054107
Registered date:13/04/2024
A trial to evaluate the feasibility of using radio-controlled miniature cars to reduce preoperative anxiety in children.
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | 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 |
Date of first enrollment | 2024/03/20 |
Target sample size | 10 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Entering the operating room using RC mini-cars |
Outcome(s)
Primary Outcome | Adverse events associated with entering the operating room in RC mini-cars. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 4years-old |
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Age maximum | 7years-old |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Kyushu University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Kyushu University |
Secondary ID(s) |
Contact
public contact | |
Name | Naonori Kawakubo |
Address | 3-1-1, Maidashi, Higashiku, Fukuoka 812-8582 |
Telephone | +81-92-642-5573 |
kawakubo.naonori.061@m.kyushu-u.ac.jp | |
Affiliation | Kyushu University Faculty of Medical Sciences Pediatric Surgery |
scientific contact | |
Name | Naonori Kawakubo |
Address | 3-1-1, Maidashi, Higashiku, Fukuoka |
Telephone | +81-92-642-5573 |
kawakubo.naonori.061@m.kyushu-u.ac.jp | |
Affiliation | Kyushu University Faculty of Medical Sciences Pediatric Surgery |