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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016342
Receipt No. R000018613
Scientific Title Non-pharmacological approach for improving patient satisfaction in postoperative patients receiving intravenous patient-controlled analgesia after a major surgery.
Date of disclosure of the study information 2015/12/31
Last modified on 2016/02/26

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Basic information
Public title Non-pharmacological approach for improving patient satisfaction in postoperative patients receiving intravenous patient-controlled analgesia after a major surgery.
Acronym Non-pharmacological approach for improving patient satisfaction in postoperative patients receiving intravenous patient-controlled analgesia after a major surgery.
Scientific Title Non-pharmacological approach for improving patient satisfaction in postoperative patients receiving intravenous patient-controlled analgesia after a major surgery.
Scientific Title:Acronym Non-pharmacological approach for improving patient satisfaction in postoperative patients receiving intravenous patient-controlled analgesia after a major surgery.
Region
Asia(except Japan)

Condition
Condition postoperative pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 postoperative patients receiving patient-controlled analgesia after a major surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Patient global impression of improvement in pain measured by 11-point NRS at the third day after the surgery and patient overall satisfaction with acute pain service measured by a 5-point Likert scale with a questionnaire.
Key secondary outcomes accessibility of PCA information, quality of communication skills and instrument/workflow proficiency of our acute pain service measured by a 5-point Likert scale with a questionnaure.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 no specific SOP(standard operating procedure) during ward visits in postoperative PCA patients
Interventions/Control_2 CICARE implemented SOP during ward visits in postoperative PCA patients
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Adult patients (aged between 20 to 80 years) who received intravenous morphine via a PCA device after a major surgery for at least 2 days and without any anesthetic/surgical complication were included.
Key exclusion criteria ICU patients and those who were blind, deaf, sedated or suffered cognitive impairment. Based on chart review, patients with daily use of opioid analgesics and nonopioid medications (eg, gabapentinoids, tricyclic antidepressants) for 30 days or longer before their operation were also excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jen-Yin Chen
Organization Chi Mei Medical Center
Division name department of anesthesiology
Zip code
Address No. 901, Zhonghua Rd., Yongkang City, Tainan County 710, Taiwan.
TEL +886-6-2812811-53351
Email chenjenyin@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Chia-Chun Chuang
Organization Chi Mei Medical Center
Division name department of anesthesiology
Zip code
Address No. 901, Zhonghua Rd., Yongkang City, Tainan County 710, Taiwan.
TEL +886-6-2812811-53322
Homepage URL
Email common0322@hotmail.com

Sponsor
Institute Chi Mei Medical Center
Institute
Department

Funding Source
Organization Chi Mei Medical Center
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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 Chei Mei Medical Center (Taiwan)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 31 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 Enrolling by invitation
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 26 Day
Last modified on
2016 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018613

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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