UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047537 |
|---|---|
| Receipt number | R000054208 |
| Scientific Title | Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/04/20 15:50:24 |
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Basic information
Public title
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale
Acronym
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale
Scientific Title
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale
Scientific Title:Acronym
Reliability and validity of the Japanese version of the modified Yale Preoperative Anxiety Scale
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 purpose of this study was to develop a Japanese version of the mYPAS and to use the developed instrument to assess anxiety in Japanese preoperative pediatric patients to establish its reliability and validity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using the Japanese version of the mYPAS developed in this study, several raters will score children's preoperative anxiety on videos taken from entry to induction to examine inter-rater reliability.
1) Reliability was measured in two ways: interrater reliability and internal consistency. The inter-rater reliability was assessed with kappa.
Key secondary outcomes
2) Spearman's rank correlation test was used to assess the correlation between the Japanese version of the m-YPAS and the Japanese version of the STAIC.
3) Perform ROC curve analysis to determine sensitivity and specificity at cutoff values using Youden index.
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
| 5 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing surgery, orthopedics, otolaryngology, ophthalmology, urology, plastic surgery, etc.
2) Patients with 1 or 2 by the American society of Anesthesiologists
3) Patients who have received a full explanation of their participation in this study, and who have given written consent on behalf of the patient based on a thorought understanding of the study.
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 deemed inappropriate by the attending physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Norifumi |
| Middle name | |
| Last name | Kuratani |
Organization
Saitama Prefectual Children's medical center
Division name
Anesthesiology
Zip code
330-8777
Address
1-2 Shintoshin, Chuo-ku, Saitama-shi, Saitama
TEL
048-601-2200
nori-kuratani@umin.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Ishibashi |
Organization
Saitama Prefectual Children's medical center
Division name
Anesthesiology
Zip code
330-8777
Address
1-2 Shintoshin, Chuo-ku, Saitama-shi, Saitama
TEL
048-601-2200
Homepage URL
kawabe.chika@saitama-pho.jp
Sponsor or person
Institute
Saitama Prefectual Children's medical center
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefectual Children's medical center
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
Saitama Prefectual Children's medical center
Address
1-2 Shintoshin, Chuo-ku, Saitama-shi, Saitama
Tel
048-601-2200
kawabe.chika@saitama-pho.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
| 2022 | Year | 04 | Month | 20 | 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
| 2022 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Video recording of children aged 5-12 scheduled for surgery under general anesthesia, from entry into the operating room to induction on the day of surgery. Later, several raters will use the Japanese version of the mYPAS to score the child's preoperative anxiety on the captured videos and examine inter-rater reliability.
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054208
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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