Pain's Treatment With Virtual Reality in Hemodialysis

Chronic Pain Clinical Trial

Official title:

Pain's Treatment With Virtual Reality in Hemodialysis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05189899
• Other study ID #: CSAPG-2
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Chronic Pain
• Kidney Diseases
• Renal Insufficiency, Chronic

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