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The trial was not performed because logistical problems
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With virtual reality | Active Comparator | One hemodialysis session with virtual reality |
|
| without virtual reality | No Intervention | One hemodialysis session without virtual reality |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | One hemodialysis session with virtual reality and one other without it |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain measured by using the revised Faces Pain Scale - Revised (FPS-R) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety measured by using the Hamilton scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Crossover clinica trial
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| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |