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

NCT05729113 | Completed

• 1 other identifier: Pain perception
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Dialysis

Keywords

Arteriovenous Fistula; Renal Insufficiency Chronic; Quality of Life; Distraction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Distraction technique

EXPERIMENTAL

Behavioral: Distraction technique

Pain monitor

NO INTERVENTION

Interventions

Distraction technique BEHAVIORAL

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

Distraction technique

Eligibility Criteria

• Age: 62 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joana Sofia Dias Pereira de Sousa: lead
• Instituto Politécnico de Leiria: collaborator

Study Sites (1)

Diaverum

Figueira da Foz Municipality, Portugal

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Joana P Sousa, PhD

  Instituto Politécnico de Leiria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 15, 2023
• Study Start: July 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: September 15, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)