Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000890033
Ethics application status
Approved
Date submitted
7/10/2010
Date registered
19/10/2010
Date last updated
3/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Can pain words hurt? A randomised trial comparing comfort versus pain scores following caesarean section
Scientific title
Pain versus Comfort scores after caesarean section: a randomised trial
Secondary ID [1] 252837 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain after caesarean section 258291 0
Condition category
Condition code
Anaesthesiology 258487 258487 0 0
Pain management
Reproductive Health and Childbirth 258540 258540 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On the post-anaesthetic ward round within 10-36 hours after caesarean section, eligible women will be randomised to one of two groups. One group will be asked questions specifically about their level of comfort (Group C). The other group will be asked questions specifically about their level of pain (Group P). Overall, every participant will be asked the same questions, however the questions may be asked in a different order, depending on the Group. Participants will be interviewed by one of three researcher anaesthetists, medical students or midwives.

After a greeting and introduction, women in Group C will be asked “Are you comfortable?”. If the woman says that they are not comfortable, they will be asked why they are not comfortable. They will then be asked for a Verbal Numerical Rating Score (VNRS) for comfort. More specifically they will be asked: “With regard to your healing caesarean wound, can you please rate your comfort level at rest, where 10 is most comfortable and zero is least comfortable” and then “When you move, how would you rate your level of comfort where 10 is most comfortable and zero is least comfortable?”. Women will then be asked “Is the healing wound bothering you?”, and then, “How much is the healing wound bothering you, where zero is least bothersome and 10 is most bothersome?”, and then “Would you like any additional medication to get you more comfortable?”. Women will then be asked to indicate how comfortable they are feeling, at rest and on movement, on a 100mm sliding Visual Analogue Scale (VAS) for comfort. Patient will then be asked “Do you have any pain?” and then will be asked for a VNRS for pain at rest and on movement, and their VAS for pain at rest and on movement. Women will then be asked “Would you prefer to be asked about your comfort level or your pain level or do you have no preference?”. If the woman reported that she was comfortable earlier in the interview, she will be asked “Earlier in this interview when you said that you were comfortable, did you have any pain at that exact moment in time”. If the woman reported that she was comfortable, and then later said she was in pain, she will then be asked “Why did you say you were comfortable even though later you said you were in pain?”. And finally, women will be asked whether their pain is an unpleasant experience or something that is not unpleasant.
Intervention code [1] 257317 0
Other interventions
Comparator / control treatment
As in Group C, Group P women will be interviewed within 10-36 hours after caesarean by one of three researchers. Following a greeting and introduction, Group P will be asked “Do you have any pain?” They will then be asked “Can you please rate your pain level at rest, where 10 is most painful and zero is least painful?” and then “When you move, how would you rate your pain where 10 is most painful and zero is least painful” Women will then be asked “Does the pain bother you?” and then “Would you like additional pain relief?”. Women will then be asked to indicate how much pain they have, at rest and on movement, on a 100mm sliding VAS for pain. Then women will be asked “Although that you have said that you have pain, would you say that you are comfortable?” Then they will be asked for a VNRS and a VAS for comfort at rest and on movement, whether they would prefer to be asked about their comfort level or pain level, and whether their pain is unpleasant or not unpleasant, as in Group C.
Control group
Active

Outcomes
Primary outcome [1] 259323 0
Pain severity as measured by a zero to ten point Verbal Numerical Rating Score (VNRS) for pain and the VNRS for comfort.
Timepoint [1] 259323 0
Within 10-36 hours after caesarean section women will be randomised to one of the two groups. They will be interviewed within 5 minutes of randomisation.
Secondary outcome [1] 265769 0
Pain severity as measured by 100mm Visual Analogue Scale (VAS) for comfort and VAS for pain.
Timepoint [1] 265769 0
Within 10-36hours after caesarean section women will be randomised to one of the two groups. They will be interviewed within 5 minutes of randomisation.
Secondary outcome [2] 265770 0
Whether or not the pain is bothersome when asked "Is the healing wound bothering you?" in Group C, or "Does the pain bother you?" in Group P. This outcome is dichotomous - either yes or no.
Timepoint [2] 265770 0
Within 10-36 hours after caesarean section women will be randomised to one of the two groups. They will be interviewed within 5 minutes of randomisation.
Secondary outcome [3] 265771 0
Whether or not the patient would like additional analgesia.
Timepoint [3] 265771 0
Within 10-36hours after caesarean section women will be randomised to one of the two groups. They will be interviewed within 5 minutes of randomisation.
Secondary outcome [4] 265790 0
Whether the patient prefers to be asked about their comfort level, or their pain level, or they do not have a preference
Timepoint [4] 265790 0
Within 10-36hours after caesarean section women will be randomised to one of the two groups. They will be interviewed within 5 minutes of randomisation.
Secondary outcome [5] 265791 0
Whether the patient considers their pain as unpleasant or not unpleasant.
Timepoint [5] 265791 0
Within 10-36hours after caesarean section women will be randomised to one of the two groups. They will be interviewed within 5 minutes of randomisation.

Eligibility
Key inclusion criteria
All English speaking women who are scheduled for post-anaesthesia review following caesarean section.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded if they need an interpreter, are deaf, have an intellectual disability, or have a history of chronic pain or opioid abuse.

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)
Women will be interviewed between 10-36 hours after caesarean section. Eligibility will be assessed by case note review and then eligible women will be randomised to one of the two study groups immediately before the interview. Allcoation concealment is achieved by consecutively numbered opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software.
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
Completed
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3297 0
5006

Funding & Sponsors
Funding source category [1] 257747 0
Self funded/Unfunded
Name [1] 257747 0
Country [1] 257747 0
Australia
Primary sponsor type
Hospital
Name
Women’s & Children’s Hospital
Address
72 King William Road,
Adelaide, S.A. 5006
Country
Australia
Secondary sponsor category [1] 256959 0
None
Name [1] 256959 0
Address [1] 256959 0
Country [1] 256959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259799 0
Child Youth and Women's Health Service (CYWHS) Women's and Children's Hospital (WCH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 259799 0
Ethics committee country [1] 259799 0
Australia
Date submitted for ethics approval [1] 259799 0
Approval date [1] 259799 0
08/06/2010
Ethics approval number [1] 259799 0
EC00197

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31717 0
Address 31717 0
Country 31717 0
Phone 31717 0
Fax 31717 0
Email 31717 0
Contact person for public queries
Name 14964 0
Dr Allan M Cyna
Address 14964 0
Department of Women’s Anaesthesia
Women’s & Children’s Hospital,
72 King William Road,
Adelaide, S.A. 5006
Country 14964 0
Australia
Phone 14964 0
+61 8 81617630
Fax 14964 0
+61 8 81617020
Email 14964 0
[email protected]
Contact person for scientific queries
Name 5892 0
Dr Allan M Cyna
Address 5892 0
Department of Women’s Anaesthesia
Women’s & Children’s Hospital,
72 King William Road,
Adelaide, S.A. 5006
Country 5892 0
Australia
Phone 5892 0
+61 8 81617630
Fax 5892 0
+61 8 81617020
Email 5892 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
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