Chronic Kidney Diseases, Chronic Pain
Conditions
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.
Interventions
DEVICEVirtual reality
One hemodialysis session with virtual reality and one other without it
Sponsors
Consorci Sanitari de l'Alt Penedès i Garraf
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover clinica trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain measured by using the revised Faces Pain Scale - Revised (FPS-R) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety measured by using the Hamilton scale | 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. |
Outcome results
None listed