Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000741684
Ethics application status
Approved
Date submitted
8/11/2005
Date registered
14/11/2005
Date last updated
18/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of communication during venous cannulation: a randomised controlled trial.
Scientific title
The effect of communication on pain during venous cannulation: a randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reducing patient discomfort during intravenous (IV) cannula placement 893 0
Condition category
Condition code
Alternative and Complementary Medicine 961 961 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves communicating information prior to IV cannula insertion without using words with emotional negative content such as "sharp", "hurt" "sting". Ie. "I am about to insert the drip".

The intervention will be administered within 5 minutes of the IV cannulation.
Intervention code [1] 753 0
Prevention
Comparator / control treatment
Control communication uses typical language currently used prior to insertion of IV cannula ie "I am about to insert the drip which is sharp and will sting a bit".

The control will be administered within 5 minutes of the IV cannulation.
Control group
Active

Outcomes
Primary outcome [1] 1272 0
Pain scores assessed by a verbal rating score.
Timepoint [1] 1272 0
Primary outcomes will be measured within 5 minutes of the IV cannulation
Primary outcome [2] 1273 0
Pain scores assessed by a Likert score.
Timepoint [2] 1273 0
Primary outcomes will be measured within 5 minutes of the IV cannulation
Secondary outcome [1] 2303 0
Patient movement and verbalisation.
Timepoint [1] 2303 0
Secondary outcomes will be measured within 5 minutes of the IV cannulation.

Eligibility
Key inclusion criteria
Adults requiring the insertion of an intravenous cannula as part of their routine care.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who require an interpretor or who have recently taken analgesia.

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)
Allocation concealment will be achieved using sequentially numbered opaque sealed envelopes (prepared independently from the research team) that are opened just prior to administering the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers in blocks prepared by the Department of Biomedical statistics at our institution
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1059 0
Self funded/Unfunded
Name [1] 1059 0
Country [1] 1059 0
Primary sponsor type
Individual
Name
Dr AM Cyna
Address
Department of Women's Annaesthesia
Women's and Children's Hospital
Adelaide South Australia 5006
Country
Australia
Secondary sponsor category [1] 920 0
None
Name [1] 920 0
None
Address [1] 920 0
Country [1] 920 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35977 0
Address 35977 0
Country 35977 0
Phone 35977 0
Fax 35977 0
Email 35977 0
Contact person for public queries
Name 9942 0
Dr A.M.Cyna
Address 9942 0
Department of Anaesthesia
Women's and Children's Hospital
72 King Willaim Rd
North Adelaide SA 5006
Country 9942 0
Australia
Phone 9942 0
+61 81617000
Fax 9942 0
Email 9942 0
[email protected]
Contact person for scientific queries
Name 870 0
Dr A.M. Cyna
Address 870 0
Department of Anaesthesia
Women's and Children's Hospital
72 King Willaim Rd
North Adelaide SA 5006
Country 870 0
Australia
Phone 870 0
+61 8 81617000
Fax 870 0
Email 870 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.