Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000121268
Ethics application status
Approved
Date submitted
1/12/2008
Date registered
19/02/2009
Date last updated
19/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open versus specific questioning to assess pain during anaesthetic follow-up after caesarean birth: a randomised trial
Scientific title
Open versus specific questioning to assess pain during anaesthetic follow-up after caesarean birth: a randomised trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Use of language to describe wound healing after caesarean birth 4048 0
Condition category
Condition code
Anaesthesiology 4472 4472 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On the postoperative anaesthetic review round within 12-72 hours of the surgery, all Women allocated to open questioning will be asked how they are feeling followed within 5 minutes by the closed question of whether they are comfortable. If they have not already that they have pain, they will then immediately be asked whether they have pain or not and how severe is their pain. This will be measured using a ten point Verbal Numerical Rating Score (VNRS) with zero being no pain while 10 is the worst pain imaginable. Those women allocated to closed questioning will be asked whether they are in pain and to score the pain first prior to then being asked (within 5 minutes) how they are feeling.
Intervention code [1] 3955 0
Treatment: Other
Intervention code [2] 3972 0
Prevention
Comparator / control treatment
Ten point Verbal Numerical Rating Score (VNRS) Pain score asked within 5 minutes after asking the open question
Control group
Active

Outcomes
Primary outcome [1] 5137 0
Ten point Verbal Numerical Rating Score (VNRS) Pain score
Timepoint [1] 5137 0
Within 72 hours of caesarean section
Secondary outcome [1] 8646 0
there are no other key secondary outcomes
Timepoint [1] 8646 0
N/A

Eligibility
Key inclusion criteria
within 72 hour of their caesarean section
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women requiring a translator and those with intellectual impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
subjects will be interviewed as per our routine follow-up (usually) the next day after caesarean section but within 12-72 hours of surgery. Immediately prior to this interview subjects will be randomly allocated to pain score questioning before or after open questioning. Allocation concealment is achieved by opening consecutively numbered opaque sealed envelopes. Open questions will be asking patients how they are feeling. Closed questions will be VNRS pain scores and whether they are in pain
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number sequence generator
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
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4418 0
Self funded/Unfunded
Name [1] 4418 0
Country [1] 4418 0
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Rd
Adelaide, SA 5006
Country
Australia
Secondary sponsor category [1] 3977 0
None
Name [1] 3977 0
Address [1] 3977 0
Country [1] 3977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6281 0
Child Youth and Women's Health Service (CYWHS) and Human Research Ethics Committee (HREC)
Ethics committee address [1] 6281 0
72 King William Rd
Adelaide, SA 5006
Ethics committee country [1] 6281 0
Australia
Date submitted for ethics approval [1] 6281 0
01/10/2008
Approval date [1] 6281 0
19/11/2008
Ethics approval number [1] 6281 0
REC2109/10/11

Summary
Brief summary
The primary purpose of this study is to determine whether the perception of pain is affected by the way women are questioned after their caesarean birth
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29183 0
Address 29183 0
Country 29183 0
Phone 29183 0
Fax 29183 0
Email 29183 0
Contact person for public queries
Name 12340 0
Dr Allan M Cyna
Address 12340 0
Women's and Children's Hospital
72 King William Rd
Adelaide, SA 5006
Country 12340 0
Australia
Phone 12340 0
+61881617000
Fax 12340 0
Email 12340 0
[email protected]
Contact person for scientific queries
Name 3268 0
Dr Allan Cyna
Address 3268 0
72 King William Rd
Adelaide, SA 5006
Country 3268 0
Australia
Phone 3268 0
+61881617000
Fax 3268 0
Email 3268 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.