Pain's Treatment With Virtual Reality in Hemodialysis

NCT05189899 | Withdrawn

• 1 other identifier: CSAPG-2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety measured by using the Hamilton scale

  From 1 hour before dialysis connection to 30 minutes after

Study Arms (2)

With virtual reality

ACTIVE COMPARATOR

One hemodialysis session with virtual reality

Device: Virtual reality

without virtual reality

NO INTERVENTION

One hemodialysis session without virtual reality

Interventions

Virtual reality DEVICE

One hemodialysis session with virtual reality and one other without it

With virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemodialysis for at least 3 months
• Pain for for at least 3 months
• Signature of informed consent

You may not qualify if:

• Pain from a traumatology disease
• Formal diagnose of dementia

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

MeSH Terms

Conditions

Chronic Pain; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover clinica trial

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: January 13, 2022
• Study Start: February 1, 2022
• Primary Completion: April 15, 2022
• Study Completion: May 1, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02