Pain's Treatment With Virtual Reality in Hemodialysis

NCT ID: NCT05189899

Last Updated: 2024-02-28

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-05-01

Brief Summary

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Pain is a frequent and difficult to treat symptom in patients with advanced kidney disease undergoing hemodialysis. Pharmacokinetics and pharmacodynamics have complex pharmacokinetics and pharmacodynamics in these types of patients, so non-pharmacological therapies could be very useful. In this project the investigators propose to test whether the use of a virtual reality platform, designed by the company Psious and tested in other clinical settings, can reduce the pain that patients experience during connection to the dialysis session.

For this the investigators have designed a crossover clinical trial, which will be carried out on 107 hemodialysis patients, in which the intensity of pain (primary objective) and anxiety (secondary objective) that patients experience in the sessions in which participants are treated Using virtual reality, it will be compared with the intensity of pain and anxiety experienced by these same patients, in sessions in which the virtual reality platform is not used.

The results of this clinical trial can support the use of virtual reality as an adjunctive pain treatment in patients with advanced kidney disease.

Detailed Description

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Conditions

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Chronic Pain Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover clinica trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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With virtual reality

One hemodialysis session with virtual reality

Group Type ACTIVE_COMPARATOR

Virtual reality

Intervention Type DEVICE

One hemodialysis session with virtual reality and one other without it

without virtual reality

One hemodialysis session without virtual reality

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality

One hemodialysis session with virtual reality and one other without it

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hemodialysis for at least 3 months
* Pain for for at least 3 months
* Signature of informed consent

Exclusion Criteria

* Pain from a traumatology disease
* Formal diagnose of dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CSAPG-2

Identifier Type: -

Identifier Source: org_study_id

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