Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000042741
Ethics application status
Approved
Date submitted
11/01/2013
Date registered
14/01/2013
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
the role of relative accompany in relieving pain and nervousness of patients undergoing transrectal ultrasound guided biopsy of prostate
Scientific title
relative accompany for patients undergoing transrectal ultrasound guided biopsy of prostate - the evaluation of its role in relieving biopsy related pain and nervousness
Secondary ID [1] 281753 0
Nil
Universal Trial Number (UTN)
U1111-1138-3868
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the pain related to prostate biopsy 288063 0
Condition category
Condition code
Renal and Urogenital 288435 288435 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
when the patient undergoes prostate biopsy, his spouse or sibling will accompany hime; in the control group, no relative will accompany him when biopsy is performed
Intervention code [1] 286291 0
Behaviour
Comparator / control treatment
the patient will undergo biopsy without accompany
Control group
Active

Outcomes
Primary outcome [1] 288603 0
the pain related to biopsy was assessed with VAS scale
Timepoint [1] 288603 0
immediately after biopsy
Secondary outcome [1] 300574 0
the nervousness related to biopsy was assessed with VAS scale
Timepoint [1] 300574 0
immediately after biopsy

Eligibility
Key inclusion criteria
all patiens have indication for prostate biopsy
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
can not communicate with others

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
14/01/2013
Actual
14/01/2013
Date of last participant enrolment
Anticipated
Actual
29/03/2013
Date of last data collection
Anticipated
Actual
29/03/2013
Sample size
Target
80
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 4785 0
China
State/province [1] 4785 0
shanghai

Funding & Sponsors
Funding source category [1] 286539 0
Government body
Name [1] 286539 0
Chinese GCP grant project fund
Country [1] 286539 0
China
Primary sponsor type
Individual
Name
zhou tie
Address
changhai road 168#, shanghai 200433
Country
China
Secondary sponsor category [1] 285326 0
Hospital
Name [1] 285326 0
changhai hospital
Address [1] 285326 0
changhai road 168# 200433
Country [1] 285326 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
for invasive intenvetion, patients will worry about the paian and most of them become nervous before the procedure. It is also true for transrectal ultrasound guided biopsy of prostate. We think the accomany of the relative will releave the pain and nervousness related to biopsy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36410 0
Dr zhou tie
Address 36410 0
changhai road 168#, shanghai 200433
Country 36410 0
China
Phone 36410 0
+86-21-13918360523
Fax 36410 0
Email 36410 0
[email protected]
Contact person for public queries
Name 36411 0
zhou tie
Address 36411 0
changhai road 168#, shanghai 200433
Country 36411 0
China
Phone 36411 0
+86-21-13918360523
Fax 36411 0
Email 36411 0
[email protected]
Contact person for scientific queries
Name 36412 0
zhou tie
Address 36412 0
changhai road 168#, shanghai 200433
Country 36412 0
China
Phone 36412 0
+86-21-13918360523
Fax 36412 0
Email 36412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
the patients were informed to keep their information secrete when enrolled


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.