Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation.

Renal Dialysis Clinical Trial

Official title:

Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation - a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729113
• Other study ID #: Pain perception
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: February 2023
• Source: Instituto Politécnico de Leiria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain in patients under hemodialysis affects chronic renal patients' quality of life. Distraction has been effective in controlling pain induced by the insertion of needles. Once applied adequately, distraction promotes endorphins' release, with efficacy in acute pain. This study aims to evaluate pain perception while puncturing the hemodialysis device using an anti-stress ball as a distraction strategy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 15, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 62 Years to 77 Years

Eligibility

Inclusion Criteria:

• adults over 18 years old

• able to read and write

• vascular access by a fistula or arteriovenous prosthesis, cannulated with a 15G needle

• vascular access at least with month old

Exclusion Criteria:

• patients under 18 years

• can't be able to read and/or write

• usage of topical anesthetics before treatment

• vascular access by a fistula or arteriovenous prosthesis, cannulated with smaller or larger 15G needles

• vascular access under one-month-old

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

Behavioral:
• Distraction technique
Distribution of an anti-stress ball before the moment of cannulation of the vascular access and instructing to place it in hand opposite the limb of the vascular access

Locations

Country	Name	City	State
Portugal	Diaverum	Figueira Da Foz

Sponsors (2)

Lead Sponsor	Collaborator
Joana Sofia Dias Pereira de Sousa	CiTechCare

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception by hemodialysis patients	Assess the perceived pain by chronic kidney disease patients at the time of vascular access cannulation for hemodialysis, by a pain scale. On the intervention group was used a distraction technique, using an anti-stress ball, at weeks 7-12. On the control group there was only the measurement of pain by scale.	12 weeks