Effect of Virtual Reality on Pain and Anxiety During Arteriovenous Fistula Cannulation in Hemodialysis Patients (VirtualReality)

Effect of Virtual Reality on Pain and Anxiety During Arteriovenous Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

This study aims to determine the effect of virtual reality (VR) goggles used during arteriovenous fistula (AVF) cannulation in hemodialysis patients on pain and anxiety levels.

The study is designed as a parallel-group randomized controlled trial and will be conducted with 50 patients receiving treatment at a dialysis center. Participants will be randomly assigned to an experimental group (n=25) and a control group (n=25).

Patients in the experimental group will be shown visual-auditory content via VR goggles during AVF needle insertion, while the control group will receive routine care. Data will be collected using the Demographic Information Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI). Statistical analyses will include appropriate comparative and correlational tests to evaluate differences between groups and relationships between variables.

Study Overview

• Status: Completed
• Conditions: Fistulas Arteriovenous; Hemodialysis Patient
• Intervention / Treatment: Device: Virtual Reality Group; Other: Routine Procedure

Detailed Description

After generating the randomization list for participant allocation, the study materials will be prepared, including informed consent forms, the Descriptive Characteristics Form, the Visual Analog Scale (VAS), and the State Anxiety Inventory (SAI).

Participants will be assigned to experimental and control groups according to the randomization list. In the experimental group, virtual reality intervention will be applied during AVF needle insertion, while the control group will receive standard care procedures.

To ensure standardization of the cannulation procedure, all patients in both groups will be cannulated using a 16-gauge arterial and venous needle, inserted at a 30°-45° angle and at least 5 cm from the fistula region, by the same certified hemodialysis nurse. The needle will be secured with hypoallergenic tape.

Fifteen minutes after fistula cannulation, outcome measurements will be performed using the Visual Analog Scale (VAS) and the State Anxiety Inventory (SAI).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Selçuklu
    • Konya, Selçuklu, Turkey (Türkiye), 42020
      • Daviva Private Konya Dialysis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older,
• Receiving treatment via AVF,
• Having no visual impairment,
• Giving voluntary consent.

Exclusion Criteria:

• Patients with catheter use,
• Communication problems,
• Antipsychotic medication use,
• Analgesic use in the last 12 hours,
• Failed (multiple) needle insertion attempts

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; Patients receive VR during cannulation	Device: Virtual Reality Group; Prior to cannulation, SG goggles were worn, immersive visual/auditory content was shown during the procedure, and the goggles were removed 15 minutes after needle insertion for final measurements. To standardize the procedure, all needle insertions were performed by the same experienced nurse, using a size 16 needle, at least 5 cm away from the fistula site, and at an angle of 30°-45°.; Other Names: Virtual Reality
Active Comparator: Control Group; Routine Procedure	Other: Routine Procedure; Only the clinic's routine procedures were followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.	15 minutes after AVF cannulation
Anxiety Level	Anxiety levels will be assessed using the State Anxiety Inventory (SAI). Higher scores indicate higher anxiety levels.	15 minutes after AVF cannulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity from BaselineBaseline Values"	Change in VAS score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.	From 15 minutes before cannulation to 15 minutes after cannulation
Change in Anxiety Level from Baseline	Change in SAI score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.	From 15 minutes before cannulation to 15 minutes after cannulation

Collaborators and Investigators

• Sponsor: KTO Karatay University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2025
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Virtual Reality; Hemodialysis; State Anxiety
• Additional Relevant MeSH Terms: Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Arteriovenous Fistula
• Other Study ID Numbers: KTO Karatay University AVFSTL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data is not shared, or may be shared only to a limited extent, due to patient privacy, ethical guidelines, and legal regulations (e.g., data protection). Protecting this data is critical to ensuring patient safety and confidence in research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No