Pain's Treatment With Virtual Reality in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Pain's Treatment With Virtual Reality in Hemodialysis

Conditions
-----------------
Chronic Pain, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Device: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be under hemodialysis for more than 3 months To have pain for more than 3 months To firm the informed consent Exclusion Criteria: To have pain because a traumatological factor To be diagnosed from dementia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover clinica trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With virtual reality<br>One hemodialysis session with virtual reality | Device: Virtual reality<br>* One hemodialysis session with virtual reality and one other without it<br>|
| No Intervention: without virtual reality<br>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 Faces Pain Scale - Revised (FPS-R) | Pain measured by using the Faces Pain Scale - Revised (FPS-R) | 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 | Anxiety measured by using the Hamilton scale | From 1 hour before dialysis connection to 30 minutes after |