A randomized trial comparing standard hemodialysis needling to buttonhole needling: STAN-B study

ISRCTN ISRCTN94795553
DOI https://doi.org/10.1186/ISRCTN94795553
Secondary identifying numbers N/A
Submission date
17/05/2006
Registration date
03/07/2006
Last edited
03/04/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jennifer MacRae
Scientific

Foothills Hospital
Division of Nephrology
1403 29th Street
North West
Calgary
T2N 2T9
Canada

Phone +1 403 944 2745
Email jennifer.macrae@calgaryhealthregion.ca

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSTAN-B Study
Study objectivesButtonhole needling of patients with an arteriovenous fistula (AVF) will be associated with a decrease in patient-perceived pain compared to standard needling.
Ethics approval(s)Approved by the Conjoint Health Research Ethics Board on 20/04/2006, reference number: E-20037
Health condition(s) or problem(s) studiedArteriovenous fistula during hemodialysis
InterventionButtonhole needling versus standard needling
Intervention typeOther
Primary outcome measurePatient-perceived pain
Secondary outcome measures1. AVF trauma
2. Time to hemostasis
3. Ease of needling from nursing perspective
4. AVF infection
Overall study start date01/07/2006
Completion date01/07/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants140
Key inclusion criteria1. Chronic hemodialysis patients being treated with dialysis with an AVF
2. An AVF that has been needled consistently for at least four weeks
3. Expected to remain on dialysis for at least two months
4. Aged 18 years or older
5. Able to give informed consent
Key exclusion criteriaAn active AVF infection
Date of first enrolment01/07/2006
Date of final enrolment01/07/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

Foothills Hospital
Calgary
T2N 2T9
Canada

Sponsor information

University of Calgary (Canada)
University/education

Department of Medicine
1403 29th Street
North West
Calgary
T2N 2T9
Canada

ROR logo "ROR" https://ror.org/03yjb2x39

Funders

Funder type

University/education

University of Calgary

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2012 Yes No