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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Dialysis
• Intervention / Treatment: Behavioral: Distraction technique

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Figueira Da Foz, Portugal
    • Diaverum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 62 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distraction technique	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
No Intervention: Pain monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Joana Sofia Dias Pereira de Sousa
• Collaborators: CiTechCare

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Distraction; Arteriovenous Fistula; Renal Insufficiency Chronic
• Other Study ID Numbers: Pain perception

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No