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OpenTrials
Completed

NCT Number: NCT05807906

The Effect of Virtual Reality Application on Pain Due to Fistula Puncture 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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Application

Other

The patient will continue to monitor the virtual reality application during the fistula puncture procedure.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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