Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001458123
Ethics application status
Approved
Date submitted
30/05/2019
Date registered
22/10/2019
Date last updated
17/02/2021
Date data sharing statement initially provided
22/10/2019
Date results information initially provided
17/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Massage for vascular access pain
Scientific title
Does tactile stimuli lower the pain during vascular access?
Secondary ID [1] 298058 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inguinal hernia repair, 313050 0
Condition category
Condition code
Anaesthesiology 311548 311548 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We scheculed elective general surgeries with ASA 1-3, 18-65 old patients. By using closed envelope randomisation technique, anesthesiologists give tactile stimulus by flicking the access route of cannula for 15 seconds for one group then establish the intravascular cannula. Anesthesiologists, establish routine intravascular access (without tactile stimulus) for the second group then establish intravasculer cannule. After then we ask visual analog scale for both groups. We establish 20 G cannule on the right hand for both groups.
Intervention code [1] 314621 0
Prevention
Comparator / control treatment
. Anesthesiologists establish intravascular access without flicking before giving anesthesia .
Control group
Active

Outcomes
Primary outcome [1] 320257 0
we used Visual Analog scale to assess pain scores
Timepoint [1] 320257 0
after the tactile stimulus, anesthesiologists establish the vascular access, then we ask the pain score immediately after the intervention
Secondary outcome [1] 371005 0
nil
Timepoint [1] 371005 0
nil

Eligibility
Key inclusion criteria
18-65 years old
elective general surgeries
men/women
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no cancer therapies
no hospitalization
no depression
no pain therapy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2019
Actual
25/11/2019
Date of last participant enrolment
Anticipated
Actual
1/07/2020
Date of last data collection
Anticipated
1/06/2020
Actual
1/07/2020
Sample size
Target
250
Accrual to date
Final
250
Recruitment outside Australia
Country [1] 21537 0
Turkey
State/province [1] 21537 0

Funding & Sponsors
Funding source category [1] 302590 0
Self funded/Unfunded
Name [1] 302590 0
Country [1] 302590 0
Primary sponsor type
Individual
Name
gözde bumin aydin
Address
gözde bumin aydin
Prof Dr Ahmet Taner Kislali mah. Orun villalari 2764 sok no 7
Çayyolu Ankara Turkey 06810
Country
Turkey
Secondary sponsor category [1] 302496 0
None
Name [1] 302496 0
none
Address [1] 302496 0
none
Country [1] 302496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303227 0
ankara diskapi education and research hospital
Ethics committee address [1] 303227 0
sehit Halis Demir caddesi no 12 Diskapi
Ethics committee country [1] 303227 0
Turkey
Date submitted for ethics approval [1] 303227 0
10/01/2019
Approval date [1] 303227 0
04/02/2019
Ethics approval number [1] 303227 0

Summary
Brief summary
we will include elective general surgeries with ASA 1-3, 18-65 years old patients without cancer treatments, without hospital stay or without pain therapies.
We will massage the access route of our branula for 15 seconds for one group then establish the intravascular access. We establish our routine intravascular access (without massage) for the second group. After then we ask the visual analog scale for both groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92922 0
A/Prof gözde bumin aydin
Address 92922 0

Ministry of Health Diskapi Education and Research Hospital
Anesthesiology and Reanimation Department
Sehit Ömer HalisDemir streeet no 12 diskapi
Ankara
Turkey
Country 92922 0
Turkey
Phone 92922 0
+903125962325
Fax 92922 0
Email 92922 0
[email protected]
Contact person for public queries
Name 92923 0
A/Prof gözde bumin aydin
Address 92923 0
Ministry of Health Diskapi Education and Research Hospital
Anesthesiology and Reanimation Department
Sehit Ömer HalisDemir streeet no 12 diskapi
Ankara
Turkey
Country 92923 0
Turkey
Phone 92923 0
+903125962325
Fax 92923 0
Email 92923 0
[email protected]
Contact person for scientific queries
Name 92924 0
A/Prof gözde bumin aydin
Address 92924 0
Ministry of Health Diskapi Education and Research Hospital
Anesthesiology and Reanimation Department
Sehit Ömer HalisDemir streeet no 12 diskapi
Ankara
Turkey
Country 92924 0
Turkey
Phone 92924 0
+903125962325
Fax 92924 0
Email 92924 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
I believe the material methods and the conclusion is satisfying.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 377466-(Uploaded-30-05-2019-19-34-08)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.