The Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients

February 27, 2024 updated by: Neşe Altinok Ersoy, Hacettepe University

The Effect of Virtual Reality Application on Fistula Puncture Associated Pain in Hemodialysis Patients

The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients.

Hypotheses of the Research:

H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients.

H1-2: Virtual reality application has no effect on fistula puncture-related pain in HD patients.

In the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Demographic/medical data will initially be recorded prior to fistula puncture.
  • The patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position.
  • Virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started.
  • The patient will continue to monitor the virtual reality application during the fistula puncture procedure. It will be ensured that no communication with the patient is made until the application is finished.
  • The application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • No diagnosis of neuropathic pain
  • No sedatives, analgesics and sedatives are applied 3 hours before the application.
  • Not taking recently taken antipsychotic drugs and tranquilizers,
  • Deaf and visually impaired (to mark VAS pain)
  • Without cognitive and psychiatric diagnosis
  • Open to communication and cooperation
  • Patients who agreed to participate in the study

Exclusion Criteria:

  • Kidney transplant
  • Discomfort due to virtual reality glasses
  • Suspected/diagnosed COVID-19
  • Patients who want to leave the study voluntarily
  • Death
  • Multiple fistula puncture attempts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.
Other: virtual reality application
The patient will continue to monitor the virtual reality application during the fistula puncture procedure.
No Intervention: Control Group
Routine nursing care and diet compliance narration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-VAS Scale
Time Frame: Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain scale score will measure fifth week.
VAS Scale is scored from 1 to 10. As the score increases, the severity of pain increases.
Assessing change of pain scores baseline, after each application for three weeks. Between third and fifth weeks any intervention will not be implemented and pain scale score will measure fifth week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-22-2882

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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