UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058376 |
|---|---|
| Receipt number | R000066740 |
| Scientific Title | Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (mYPAS) in children aged 2-12 years |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/06 12:01:46 |
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Basic information
Public title
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (mYPAS) in children aged 2-12 years
Acronym
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (mYPAS) in children aged 2-12 years
Scientific Title
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (mYPAS) in children aged 2-12 years
Scientific Title:Acronym
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (mYPAS) in children aged 2-12 years
Region
| Japan |
Condition
Condition
Pediatric patient scheduled for surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale (J-mYPAS), including children aged 2 to 4 years who were not assessed in previous studies. In addition, to address the limitation of prior single-center research, this study will conduct the same evaluation at a different institution to assess the broader clinical applicability of the J-mYPAS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Japanese version of the modified Yale Preoperative Anxiety Scale
Key secondary outcomes
Japanese version of the STAIC(State-Trait Anxiety Inventory for Children) 9-12 years
Visual Analogue Scale(VAS)
Numerical Rating Scale(NRS), Face Pan Scale (FS), FLACC Behavioral Pain Assessment Scale (FLACC)
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
| 2 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing surgery under general anesthesia (pediatric surgery) at our hospital.
2. Patients classified as ASA Physical Status 1 or 2 according to the American Society of Anesthesiologist.
3. Patients whose legal guardians have received a full explanation of the study, fully understood it, and provided written informed consent voluntarily.
Key exclusion criteria
1. Non-native Japanese-speaking patients or their surrogates
2. Patients with mental/developmental retardation or neurological disorders
3. Emergency surgery cases
4. Patients whose surrogate refuses to participate in this study
5. Patients who are deemed inappropriate for participation by the principal investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Kawabe |
| Middle name | |
| Last name | Chika |
Organization
Juntendo University School of Medicine, Juntendo University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
ckawabe@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Kawabe |
Organization
Juntendo University School of Medicine, Juntendo University Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ckawabe@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Center for Clinical Trials and Research, Juntendo University Hospital
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
crbjun@juntendo.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
| 2025 | Year | 08 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study targets children aged 2 to 12 years undergoing general anesthesia at Juntendo University Hospital. It aims to evaluate the inter-rater and intra-rater reliability of the Japanese version of the modified Yale Preoperative Anxiety Scale (mYPAS), as well as its concurrent validity with the anxiety VAS and STAIC.
Management information
Registered date
| 2025 | Year | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066740
