Pain's Treatment With Virtual Reality in Hemodialysis

February 27, 2024 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With virtual reality
One hemodialysis session with virtual reality
Device: Virtual reality
One hemodialysis session with virtual reality and one other without it
No Intervention: without virtual reality
One hemodialysis session without virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measured by using the revised Faces Pain Scale - Revised (FPS-R)
Time Frame: From the moment of connection to dialysis until 30 minutes later
Pain measured by using the revised Faces Pain Scale - Revised (FPS-R). The scale ranges from 0 to 10, with 0 being the absence of pain and 10 being the maximum pain
From the moment of connection to dialysis until 30 minutes later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety measured by using the Hamilton scale
Time Frame: From 1 hour before dialysis connection to 30 minutes after
Anxiety measured by using the Hamilton scale. The scale ranges from 0 to 56, being 56 the maximun level of anxiety.
From 1 hour before dialysis connection to 30 minutes after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

April 15, 2022

Study Completion (Estimated)

May 1, 2022

Study Registration Dates

First Submitted

November 20, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSAPG-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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