UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016342 |
|---|---|
| Receipt number | 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 22:58:31 |
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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
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
common0322@hotmail.com
Sponsor or person
Institute
Chi Mei Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018613
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
