UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042290 |
|---|---|
| Receipt number | R000043374 |
| Scientific Title | Validation, Feasibility and Reliability of postoperative quality of recovery score Japanese version:the QoR15J |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2024/08/13 12:23:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation, Feasibility and Reliability of postoperative quality of recovery score Japanese version:the QoR15J
Acronym
PQRS15
Scientific Title
Validation, Feasibility and Reliability of postoperative quality of recovery score Japanese version:the QoR15J
Scientific Title:Acronym
PQRS15
Region
| Japan |
Condition
Condition
Patients undergoing surgery with general anesthesia
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess fesiablity, validity and reliability of J-QOR15
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of QOR15 24h later after surgery
Key secondary outcomes
The score of QOR15 25 and 48 later after surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients >- 20-year-old
Paritens who can understand Japanese
Patients without intubation after surgery
Key exclusion criteria
Patients with cognitive dysfunction
Patients who cannnot write by themselves
Psychiatric patients
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | ida |
| Middle name | |
| Last name | Mitsuru |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
6348521
Address
Nara Kashihara Shijo-cho840
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
Nara Kashihara Shijo-cho840
TEL
09079627114
Homepage URL
nwnh0131@yahoo.co.jp
Sponsor or person
Institute
Nara Medical Unicersity
Institute
Department
Personal name
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
Nara Kashihara Shijo-cho840
Tel
09079627114
nwnh0131@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
nnn
Org. issuing International ID_1
mmm
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043374
