Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000722099
Ethics application status
Approved
Date submitted
30/08/2010
Date registered
31/08/2010
Date last updated
31/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measurement of the effectiveness of the fifth vital sign in postoperative patients: A randomized clinical trial.
Scientific title
Measurement of the effectiveness of the fifth vital sign implementation in postoperative patients: A randomized clinical trial.
Secondary ID [1] 252588 0
None
Universal Trial Number (UTN)
U1111-1114-6213
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain in postoperative patients 257557 0
fifth vital signal 257558 0
Condition category
Condition code
Anaesthesiology 257715 257715 0 0
Pain management
Surgery 257717 257717 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
fifth vital signal implementation, ie apply the scale of pain routinely along with other vital signs by nursing, and use this scale to manage the patient's pain. Application of the pain scale two times per day postoperatively, until five days after surgery
Intervention code [1] 256645 0
Other interventions
Comparator / control treatment
routine pain control without the use of pain scale, only for assessing the medical visit, until five days after surgery. Once daily for 1 hour until five days after surgery.
Control group
Active

Outcomes
Primary outcome [1] 258612 0
Improvement in post-operative pain measured by pain scale
Timepoint [1] 258612 0
five days after the surgery
Secondary outcome [1] 264525 0
patient satisfaction with pain control through a questionnaire applied once daily until the fifth day of post-operative
Timepoint [1] 264525 0
five days after the surgery

Eligibility
Key inclusion criteria
postoperative patients who were hospitalized
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Outpatients. Cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation involved contacting the holder of the allocation schedule who was 'off-site', via phone call, and randomization was done through the range of random numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Table of random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment outside Australia
Country [1] 2697 0
Brazil
State/province [1] 2697 0

Funding & Sponsors
Funding source category [1] 257125 0
Self funded/Unfunded
Name [1] 257125 0
Country [1] 257125 0
Primary sponsor type
Individual
Name
Claudio Stadnik
Address
Av. Farroupilha, 8001. Canoas.
92425-900.
Country
Brazil
Secondary sponsor category [1] 256387 0
Individual
Name [1] 256387 0
Lisiane Iuppen
Address [1] 256387 0
Av. Farroupilha, 8001. Canoas.
92425-900.
Country [1] 256387 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259168 0
Comite de Etica em Pesquisa da ULBRA RS
Ethics committee address [1] 259168 0
Av. Farroupilha, 8001. Bairro Sao Jose. Canoas/RS
CEP 92425-900.
Ethics committee country [1] 259168 0
Brazil
Date submitted for ethics approval [1] 259168 0
Approval date [1] 259168 0
10/09/2009
Ethics approval number [1] 259168 0
2009-250H

Summary
Brief summary
Through this study we verified the effectiveness of the implementation of the pain scale as the fifth vital sign in controlling postoperative pain and patient satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31282 0
Address 31282 0
Country 31282 0
Phone 31282 0
Fax 31282 0
Email 31282 0
Contact person for public queries
Name 14529 0
Claudio Marcel Berdun Stadnik
Address 14529 0
Av. Farroupilha, 8001. Bairro Sao Jose. Canoas/RS
CEP 92425-900.
Country 14529 0
Brazil
Phone 14529 0
555132273975
Fax 14529 0
555132273975
Email 14529 0
[email protected]
Contact person for scientific queries
Name 5457 0
Claudio Marcel Berdun Stadnik
Address 5457 0
Av. Farroupilha, 8001. Bairro Sao Jose. Canoas/RS
CEP 92425-900.
Country 5457 0
Brazil
Phone 5457 0
555132273975
Fax 5457 0
555132273975
Email 5457 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.