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Completed

NCT Number: NCT05729113

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

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.

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Key information

Conditions

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

Age range

62 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diaverum

Figueira da Foz Municipality, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Pain perception by hemodialysis patients

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Joana Sofia Dias Pereira de Sousa

Other

Collaborators

  • Instituto Politécnico de Leiria

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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