Pain's Treatment With Virtual Reality in Hemodialysis

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05189899
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Chronic Kidney Diseases	Device: Virtual reality	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover clinica trialCrossover clinica trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pain's Treatment With Virtual Reality in Hemodialysis
• Anticipated Study Start Date: Jan 15, 2022
• Anticipated Primary Completion Date: Apr 15, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: With virtual reality One hemodialysis session with virtual reality	Device: Virtual reality; One hemodialysis session with virtual reality and one other without it
No Intervention: without virtual reality One hemodialysis session without virtual reality

Outcome Measures

Primary Outcome Measures

1. Pain measured by using the Faces Pain Scale - Revised (FPS-R) [From the moment of connection to dialysis until 30 minutes later]

   Pain measured by using the Faces Pain Scale - Revised (FPS-R)

Secondary Outcome Measures

1. Anxiety measured by using the Hamilton scale [From 1 hour before dialysis connection to 30 minutes after]

   Anxiety measured by using the Hamilton scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

To be under hemodialysis for more than 3 months To have pain for more than 3 months To firm the informed consent

Exclusion Criteria:

To have pain because a traumatological factor To be diagnosed from dementia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Consorci Sanitari de l'Alt Penedès i Garraf
• ClinicalTrials.gov Identifier: NCT05189899
• Other Study ID Numbers: CSAPG-2
• First Posted: Jan 13, 2022
• Last Update Posted: Jan 13, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Chronic Pain

Study Results

No Results Posted as of Jan 13, 2022