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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807906
• Other study ID #: E1-22-2882
• Status: Completed
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Fistula
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-VAS Scale	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.