Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000275662
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
2/09/2005
Date last updated
4/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pain assessment and management in older people
Scientific title
Testing an innovative nursing intervention: pain assessment and management in older people
Secondary ID [1] 287791 0
Nil known
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain in older people 363 0
Condition category
Condition code
Alternative and Complementary Medicine 425 425 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test group: multifaceted educational and role modelling sessions lasting approximately 4 hours.
Intervention code [1] 331 0
Behaviour
Comparator / control treatment
Control group: inservice education session lasting one hour.
Control group
Active

Outcomes
Primary outcome [1] 486 0
Pain intensity immediately after intervention.
Timepoint [1] 486 0
Immediately after intervention.
Secondary outcome [1] 1050 0
Pain intensity
Timepoint [1] 1050 0
Pain intensity at 3-months post-intervention..

Eligibility
Key inclusion criteria
Painful acute or chronic condition.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Test and control groups at similar units in two hospitals
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
31/03/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 477 0
Other
Name [1] 477 0
Nurses Board of Victoria
Country [1] 477 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Alan Gilbert Building, Grattan Street Carlton Victoria 3010
Country
Australia
Secondary sponsor category [1] 385 0
Charities/Societies/Foundations
Name [1] 385 0
St. Vincent's Health
Address [1] 385 0
St. Vincent's Hospital, Victoria Parade Fitzroy 3065
Country [1] 385 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1455 0
St. Vincent's Hospital and St George's Hospital
Ethics committee address [1] 1455 0
Ethics committee country [1] 1455 0
Australia
Date submitted for ethics approval [1] 1455 0
Approval date [1] 1455 0
18/05/2005
Ethics approval number [1] 1455 0

Summary
Brief summary
The aim of this project is to test the immediate and long-term effects of a nursing intervention on improving pain of older patients in the hospital setting. A controlled trial will be undertaken in the geriatric evaluation and management units of two metropolitan hospitals. An organisational improvement model underpins the intervention, which comprises an educational program and clinical role modelling. This model considers the complexity of pain management activities in multidimensional ways.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36314 0
Prof Elizabeth Manias
Address 36314 0
Deakin University
221 Burwood Highway
Burwood, Victoria, AUSTRALIA 3125
Country 36314 0
Australia
Phone 36314 0
+61 3 9244 6958
Fax 36314 0
Email 36314 0
[email protected]
Contact person for public queries
Name 9520 0
Elizabeth Manias
Address 9520 0
Melbourne School of Health Sciences Grattan Street Carlton Victoria 3010
Country 9520 0
Australia
Phone 9520 0
+61383449463
Fax 9520 0
+61 3 93474172
Email 9520 0
[email protected]
Contact person for scientific queries
Name 448 0
Elizabeth Manias
Address 448 0
Melbourne School of Health Sciences Grattan Street Carlton Victoria 3010
Country 448 0
Australia
Phone 448 0
+61 3 83440778
Fax 448 0
+61 3 93474172
Email 448 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.