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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05189899
Other study ID # CSAPG-2
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date May 1, 2022

Study information

Verified date February 2024
Source Consorci Sanitari de l'Alt Penedès i Garraf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 1, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Virtual reality
One hemodialysis session with virtual reality and one other without it

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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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