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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12606000512527
Ethics application status
Approved
Date submitted
24/11/2006
Date registered
11/12/2006
Date last updated
11/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The measurement, ranking and identification of evidence-practice gaps in methods to reduce distress during procedures in the Children’s Emergency Department
Scientific title
The measurement, ranking and identification of evidence-practice gaps in methods to reduce distress during procedures in the Children’s Emergency Department
Secondary ID [1] 322 0
Auckland District Health Board: A+3585
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress during emergency medical procedures 1489 0
Condition category
Condition code
Other 1586 1586 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of distressing procedures in Childrens Emergency Department. Observed before procedure for a variable length of time (in fact length of time before procedure may be a contributing factor to distress), during the entire procedure and after the procedure while the child is in the procedure room.
Intervention code [1] 1466 0
Behaviour
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2190 0
Qualitative observations. These are currently non-focused observations looking at behaviours and language that either increase or decrease distress.
Timepoint [1] 2190 0
Observations will be focussed over several cycles. Observed before procedure for a variable length of time, during the entire procedure and after the procedure while the child is in the procedure room.
Secondary outcome [1] 3818 0
Visual analog scale and FLACC procedure pain scale (Face; Legs; Activity; Cry; Consolability).
Timepoint [1] 3818 0
Taken immediately before the procedure, during the procedure and at 2 minutes after cessation of procedure.

Eligibility
Key inclusion criteria
All children attending our department, all procedures. Procedures will be selected to include the most frequent procedures in the department that may cause distress.
Minimum age
0 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children in resuscitation will not be included due to consent timing issues.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 434 0
New Zealand
State/province [1] 434 0

Funding & Sponsors
Funding source category [1] 1730 0
Charities/Societies/Foundations
Name [1] 1730 0
Starship Foundation Summer Studentship
Country [1] 1730 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
Country
New Zealand
Secondary sponsor category [1] 1525 0
Hospital
Name [1] 1525 0
Auckland Starship Emergency Department
Address [1] 1525 0
Country [1] 1525 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3198 0
New Zealand Northern X Regional Ethics Committee-Starship Children's Emergency Department
Ethics committee address [1] 3198 0
Ethics committee country [1] 3198 0
New Zealand
Date submitted for ethics approval [1] 3198 0
Approval date [1] 3198 0
06/10/2006
Ethics approval number [1] 3198 0
NTX 06/10/132

Summary
Brief summary
The general aim of the project is to observe procedural distress occurring in the Children’s Emergency Department and identify areas for future interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27400 0
Address 27400 0
Country 27400 0
Phone 27400 0
Fax 27400 0
Email 27400 0
Contact person for public queries
Name 10655 0
Dr David Herd
Address 10655 0
Childrens Emergency Department
Starship Childrens Hospital
Private Bag 92024
Auckland
Country 10655 0
New Zealand
Phone 10655 0
+64 21412732
Fax 10655 0
Email 10655 0
[email protected]
Contact person for scientific queries
Name 1583 0
Dr David Herd
Address 1583 0
Childrens Emergency Department
Starship Childrens Hospital
Private Bag 92024
Auckland
Country 1583 0
New Zealand
Phone 1583 0
+64 21412732
Fax 1583 0
Email 1583 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.