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

NCT ID: NCT05729113

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Distraction technique

Group Type EXPERIMENTAL

Distraction technique

Intervention Type 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

Pain monitor

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

62 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Politécnico de Leiria

OTHER

Sponsor Role collaborator

Joana Sofia Dias Pereira de Sousa

OTHER

Sponsor Role lead

Responsible Party

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Joana Sofia Dias Pereira de Sousa

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joana P Sousa, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Politécnico de Leiria

Locations

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Diaverum

Figueira da Foz Municipality, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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Pain perception

Identifier Type: -

Identifier Source: org_study_id

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