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

• Sponsor: Joana Sofia Dias Pereira de Sousa (Other)
• Overall Status: Completed
• CT.gov ID: NCT05729113
• Collaborator: CiTechCare (Other)
• Enrollment: 47
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 18.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Behavioral: Distraction technique	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation - a Randomized Trial
• Actual Study Start Date: Jul 1, 2022
• Actual Primary Completion Date: Jul 1, 2022
• Actual Study Completion Date: Sep 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain perception by hemodialysis patients [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 62 Years to 77 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diaverum	Figueira Da Foz		Portugal

Sponsors and Collaborators

• Joana Sofia Dias Pereira de Sousa
• CiTechCare

Investigators

• Principal Investigator: Joana P Sousa, PhD, Instituto Politécnico de Leiria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joana Sofia Dias Pereira de Sousa, PhD, Instituto Politécnico de Leiria
• ClinicalTrials.gov Identifier: NCT05729113
• Other Study ID Numbers: Pain perception
• First Posted: Feb 15, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joana Sofia Dias Pereira de Sousa, PhD, Instituto Politécnico de Leiria: Arteriovenous Fistula; Renal Insufficiency Chronic; Quality of Life; Distraction

Study Results

No Results Posted as of Feb 15, 2023