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Pain's Treatment With Virtual Reality in Hemodialysis

Primary Purpose

Chronic Pain, Chronic Kidney Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Consorci Sanitari de l'Alt Penedès i Garraf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    With virtual reality

    without virtual reality

    Arm Description

    One hemodialysis session with virtual reality

    One hemodialysis session without virtual reality

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Anxiety measured by using the Hamilton scale
    Anxiety measured by using the Hamilton scale

    Full Information

    First Posted
    November 20, 2021
    Last Updated
    December 28, 2021
    Sponsor
    Consorci Sanitari de l'Alt Penedès i Garraf
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05189899
    Brief Title
    Pain's Treatment With Virtual Reality in Hemodialysis
    Official Title
    Pain's Treatment With Virtual Reality in Hemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2022 (Anticipated)
    Primary Completion Date
    April 15, 2022 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Consorci Sanitari de l'Alt Penedès i Garraf

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain, Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Crossover clinica trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    With virtual reality
    Arm Type
    Active Comparator
    Arm Description
    One hemodialysis session with virtual reality
    Arm Title
    without virtual reality
    Arm Type
    No Intervention
    Arm Description
    One hemodialysis session without virtual reality
    Intervention Type
    Device
    Intervention Name(s)
    Virtual reality
    Intervention Description
    One hemodialysis session with virtual reality and one other without it
    Primary Outcome Measure Information:
    Title
    Pain measured by using the Faces Pain Scale - Revised (FPS-R)
    Description
    Pain measured by using the Faces Pain Scale - Revised (FPS-R)
    Time Frame
    From the moment of connection to dialysis until 30 minutes later
    Secondary Outcome Measure Information:
    Title
    Anxiety measured by using the Hamilton scale
    Description
    Anxiety measured by using the Hamilton scale
    Time Frame
    From 1 hour before dialysis connection to 30 minutes after

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Pain's Treatment With Virtual Reality in Hemodialysis

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