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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012081
Receipt No. R000014123
Scientific Title Feasibility, Reliability, and Validity study of modified version of Japanese PQRS
Date of disclosure of the study information 2013/10/21
Last modified on 2013/10/20

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Basic information
Public title Feasibility, Reliability, and Validity study of modified version of Japanese PQRS
Acronym Feasibility, Reliability, and Validity study of modified version of Japanese PQRS
Scientific Title Feasibility, Reliability, and Validity study of modified version of Japanese PQRS
Scientific Title:Acronym Feasibility, Reliability, and Validity study of modified version of Japanese PQRS
Region
Japan

Condition
Condition Patients undergoing surgery under general or spinal anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In the past few decades, improving quality of postoperative recovery has shown to have many positive impacts on patients. It not only increase patients's satisfactory but it also shortens hospital stay, decrease medical expense.
It it important to use valid and reliable scale to assess the recovery but most of the scales are written in English and it is difficult to adopt the scale in Japan.
In the prior study, we translated Postoperative Quality of Recovery Scale into Japaneses in a proper way. This includes translation, synthesis, back-translation and expert committee. PQRS consists of six domains (cognitive, nociceptive, physical, emotional, activity of daily living, and overall perspective domain). It is assessed at multiple time points including baseline assessment before surgery.
In the prior study we assessed feasibility, reliability, and validity of Japanese version of PQRS (PQRSj). The results were as follows. Feasibility was faor but high refusal rate was observed. Reliability by Cronbach's alpha was confirmed as excellent. Validity might be improved by modifying items.
With regard to these results, we modified some of the items in PQRSj. Altering some items might have changed values of feasibility, reliability, and validity of modified version of PQRS. The aim of this study is to confirm good feasibility, reliability, and validity of modified version of PQRS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Feasibility, reliability, and validity of modified version of PQRSj
Key secondary outcomes sensivity of modified version of PQRSj on postoperative quality of Active Daily Living by different anesthetic agents

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 1) Patients able to complete Japanese questionnaire
2) Patients undergoing elective surgery
3) Patients over 20 years old
4) Patients undergoing surgery under general or spinal anesthesia
5) patients able to obtain written informed consent
Key exclusion criteria 1) Patients planned not to extubate in the operating room
2) Patients planned to transfer to Intensive Care Unit
3) Patients with cognitive decline from preoperative period
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naito Yusuke
Organization Nara Prefectural Mimuro Hospital
Division name Department of Anesthesiology
Zip code
Address 1-14-16 Mimuro Sangocho Ikomagun Nara, Japan
TEL +81-0745-32-0505
Email schneider.yusuke@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naito Yusuke
Organization Nara Prefuectural Mimuro Hospital
Division name department of Anesthesiology
Zip code
Address 1-14-16 Mimuro Sangocho Ikomagun Nara, Japan
TEL +81-0745-32-0505
Homepage URL
Email schneider.yusuke@gmail.com

Sponsor
Institute Nara medical University, Department of Anesthesiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization None

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 奈良県立三室病院(奈良)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 21 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
2013 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 21 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information None

Management information
Registered date
2013 Year 10 Month 20 Day
Last modified on
2013 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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