UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012081
Receipt number 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 11:51:48

* 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

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 or person

Institute

Nara medical University, Department of Anesthesiology

Institute

Department

Personal name



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

Value
https://center6.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