Pain's Treatment With Virtual Reality in Hemodialysis

Not Applicable

Withdrawn

• Conditions: Chronic Kidney Diseases; Chronic Pain
• Interventions: Device: Virtual reality

• Registration Number: NCT05189899
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-20
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-13
• Study Start: 2022-02-01
• Primary Completion: 2022-04-15
• Study Completion: 2022-05-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
With virtual reality	Virtual reality	One hemodialysis session with virtual reality

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.