Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000578707
Ethics application status
Approved
Date submitted
15/05/2013
Date registered
22/05/2013
Date last updated
28/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of communication styles on the pain and anxiety experienced by patients during subsequent painful procedures.
Scientific title
The effect of negative versus positive suggestion on subsequent pain and anxiety experienced during IV cannulation and epidural insertion in women undergoing caesarean section.
Secondary ID [1] 282461 0
Nil
Universal Trial Number (UTN)
U1111-1142-7223
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient's perception of pain and anxiety during painful procedures (IV cannulation and insertion of epidural) as assessed on an 11-point analog scale. 289073 0
Condition category
Condition code
Anaesthesiology 289416 289416 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Negative suggestion - prior to inserting an intra-venous cannula, the patient will have local anaesthetic injected at the site of insertion subcutaneously and will be told that this will be painful in itself. This negative suggestion will be repeated prior to insertion of the IV cannula, and prior to the subsequent insertion of local anaesthetic at the insertion site of the combined spinal epidural (CSE), and prior to the insertion of the CSE itself. Pain and anxiety scores will be assessed after injections of local anaesthetic, and after the subsequent intravenous cannulation or insertion of combined spinal epidural.
Intervention code [1] 287106 0
Other interventions
Comparator / control treatment
Positive suggestion - prior to inserting an intra-venous cannula, the patient will have local anaesthetic injected at the site of insertion subcutaneously and will be told this will numb the area and make intravenous cannulation comfortable. This positive suggestion will be repeated prior to insertion of the IV cannula, prior to insertion of local anaesthetic at the insertion site of the combined spinal epidural (CSE), and prior to insertion of the CSE itself. Pain and anxiety scores will be assessed after injections of local anaesthetic, and after the subsequent intravenous cannulation or insertion of combined spinal epidural.
Control group
Active

Outcomes
Primary outcome [1] 289521 0
Pain perception as assessed by an 11-point analog scale (NAS)
Timepoint [1] 289521 0
Pain perception will be assessed after insertion of local anaesthetic at site of intravenous cannula insertion, after IV cannula insertion , after insertion of local anaesthetic at site on insertion of epidural and after insertion of CSE.
Secondary outcome [1] 302670 0
Anxiety perception as assessed by an 11-point analog scale (NAS)
Timepoint [1] 302670 0
Anxiety perception will be assessed after insertion of local anaesthetic at site of intravenous cannula insertion, after IV cannula insertion , after insertion of local anaesthetic at site on insertion of combined spinal epidural (CSE) and after insertion of CSE.

Eligibility
Key inclusion criteria
- Women undergoing elective Caesarian section under combined spinal epidural (CSE) anaesthesia.
- Weight less than 125kg.
- Body Mass Index (BMI) less than 40.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Contradiction to spinal or CSE anaesthesia
- Fetal abnormality
- Opioid within the last 4 hours
- Previous difficult epidural or intravenous cannula insertion
- Non English speaking

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)
Enrollment of eligible patients will take place either in the elective Caesarian section pre-admission clinic or on the ward / theatre holding bay prior to any intervention. The patient will be given a description of the study verbally and on an information sheet, all questions will be answered and informed consent will be gained from the patient.
Consenting women will be randomised by computer-generated random number sequence into either:
- Placebo group (positive suggestion)
- nocebo group (negative suggestion)
Group assignments will be kept in sealed opaque envelopes numbered sequentially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur by computer-generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intention-to-treat principle will govern all analyses.
Univariate data will be expressed as mean (+/- standard deviation (SD)) for parametric data, and median (range) for non-parametric data. Analysis will be done using Student's unpaired t-test, Mann-Whitney sum rank test and Fisher Exact test as appropriate. All hypothesis tests will be two-tailed, and P<0.05 will be considered statistically significant. Data will be analysed using SPSS 15.0 for Windows statistical software.
A sample size of 90 , with 45 per treatment group, achieves >80% power with alpha 0.05, to detect a 30% difference in VAS pain and anxiety scores. This is based on a median pain score of 5 (IQR: 3-6) in the group receiving standard negative language prior to a painful procedure (nocebo group). To account for withdrawals the total sample will be increased to 100. This has been calculated using Power Analysis and Sample Size (PASS) statistical software, NCSS, Kaysville, UT, 2005).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/05/2013
Actual
Date of last participant enrolment
Anticipated
26/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 983 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 6879 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 287274 0
Hospital
Name [1] 287274 0
King Edward Memorial Hospital
Country [1] 287274 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
374 Bagot Rd, Subiaco, WA, 6008.
Country
Australia
Secondary sponsor category [1] 286027 0
None
Name [1] 286027 0
Address [1] 286027 0
Country [1] 286027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289254 0
King Edward Memorial Hospital Ethics Committee
Ethics committee address [1] 289254 0
374 Bagot Rd, Subiaco, WA, 6008.
Ethics committee country [1] 289254 0
Australia
Date submitted for ethics approval [1] 289254 0
Approval date [1] 289254 0
09/04/2013
Ethics approval number [1] 289254 0

Summary
Brief summary
We intend to assess the effects of negative suggestion / communication styles on the patient's perception of pain and anxiety during subsequent multiple painful procedures (Local anaesthetic injection, IV cannulation and combined spinal epidural insertion). We will compare these outcomes with the effects that positive suggestion / communication styles has on perception of pain and anxiety during subsequent multiple painful procedures (local anaesthetic injection, IV cannulation and epidural insertion).

Null hypothesis = negative or positive styles of communication before painful procedures will have no effect on patient's perception of pain and anxiety during subsequent multiple painful procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39854 0
Dr Twain Russell
Address 39854 0
King Edward Memorial Hospital,
Anaesthetic Department,
374 Bagot Rd,
Subiaco,
WA,
6008
Country 39854 0
Australia
Phone 39854 0
+61 8 9340 2222
Fax 39854 0
Email 39854 0
[email protected]
Contact person for public queries
Name 39855 0
Dr Nicolaas Edward Velzeboer
Address 39855 0
King Edward Memorial Hospital,
Anaesthetic Department,
374 Bagot Rd,
Subiaco,
WA,
6008
Country 39855 0
Australia
Phone 39855 0
+61 8 9340 2222
Fax 39855 0
Email 39855 0
[email protected]
Contact person for scientific queries
Name 39856 0
Dr Sara Faroughi
Address 39856 0
King Edward Memorial Hospital,
Anaesthetic Department,
374 Bagot Rd,
Subiaco,
WA,
6008
Country 39856 0
Australia
Phone 39856 0
+61 8 9340 2222
Fax 39856 0
Email 39856 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

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