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

• Sponsor: Hacettepe University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05807906
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 6.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Other: virtual reality application	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Virtual Reality Application on Fistula Puncture Associated Pain in Hemodialysis Patients
• Anticipated Study Start Date: Apr 28, 2023
• Anticipated Primary Completion Date: Nov 15, 2023
• Anticipated Study Completion Date: Nov 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain-VAS Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neşe Altinok Ersoy, Principal Investigator, Hacettepe University
• ClinicalTrials.gov Identifier: NCT05807906
• Other Study ID Numbers: E1-22-2882
• First Posted: Apr 11, 2023
• Last Update Posted: Apr 11, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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; Fistula

Study Results

No Results Posted as of Apr 11, 2023