UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060277 |
|---|---|
| Receipt number | R000068952 |
| Scientific Title | Verification of the reliability of the Japanese version of the Pediatric Scale for Quality of Recovery (PedSQoR-J) and its impact on life after discharge |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 02:05:32 |
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Basic information
Public title
Verification of the reliability of the Japanese version of the Pediatric Scale for Quality of Recovery (PedSQoR-J) and its impact on life after discharge
Acronym
Verification of the reliability of the Japanese version of the Pediatric Scale for Quality of Recovery (PedSQoR-J) and its impact on life after discharge
Scientific Title
Verification of the reliability of the Japanese version of the Pediatric Scale for Quality of Recovery (PedSQoR-J) and its impact on life after discharge
Scientific Title:Acronym
Verification of the reliability of the Japanese version of the Pediatric Scale for Quality of Recovery (PedSQoR-J) and its impact on life after discharge
Region
| Japan |
Condition
Condition
The main purpose is to examine the reliability of PedSQoR-J. In addition, we will evaluate the feasibility, validity, and responsiveness of PedSQoR-J. We will also evaluate the relationship between PedSQoR-J and intraoperative factors such as surgical procedure and vital signs, as well as the relationship between PedSQoR-J and quality of life after discharge.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main purpose is to examine the reliability of PedSQoR-J. In addition, we will evaluate the feasibility, validity, and responsiveness of PedSQoR-J. We will also evaluate the relationship between PedSQoR-J and intraoperative factors such as surgical procedure and vital signs, as well as the relationship between PedSQoR-J and quality of life after discharge.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PedSQoR-J
Key secondary outcomes
Feasibility, validity, and responsiveness of PedsQoR-J
Relationship between PedSQoR-J and intraoperative factors such as surgical procedure and vital signs, and between PedSQoR-J and quality of life after discharge
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
5.1. Study Participants
Patients scheduled for surgery at Nara Medical University between study approval and December 2026
5.2. Eligibility Criteria
- Elective surgery
- Ages 2 to 17
- American Society of Anesthesiologists Preoperative Evaluation Class I-III
- Patients whose parents or guardians are the patient's primary caregivers
- Patients who have parental or guardian consent and have obtained assent from the child
Key exclusion criteria
Surgery scheduled to end after 5PM
Emergency surgery
Non native Japanese speakers
Patients with developmental disabilities or psychiatric disorders requiring assistance with daily activities
Patients scheduled to be transferred to the intensive care unit
Patients not scheduled for extubation in the operating room
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | MITSURU |
| Middle name | |
| Last name | IDA |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
Kashihara Shijo 840
TEL
09079627114
nwnh0131@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ida |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
Kashihara Shijo 840
TEL
09079627114
Homepage URL
nwnh0131@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Ida Mitsuru
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
Kashihara shijo 840
Tel
09079627114
nwnh0131@yahoo.co.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
奈良県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 07 | 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
| 2026 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068952
