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NCT Number: NCT07622264

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

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.

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Key information

Conditions

Hemodialysis Patient Anxiety Disorders Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Fistulas Arteriovenous Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daviva Private Konya Dialysis Center

Konya, Selçuklu, 42020, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Virtual reality group

Device

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

Routine procedure

Other

Only the clinic's routine procedures were followed.

Primary outcomes

  1. Pain Intensity

    Time frame: 15 minutes after AVF cannulation

    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.

  2. Anxiety Level

    Time frame: 15 minutes after AVF cannulation

    Anxiety levels will be assessed using the State Anxiety Inventory (SAI). Higher scores indicate higher anxiety levels.

Secondary outcomes

  1. Change in Pain Intensity from BaselineBaseline Values"

    Time frame: From 15 minutes before cannulation to 15 minutes after cannulation

    Change in VAS score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.

  2. Change in Anxiety Level from Baseline

    Time frame: From 15 minutes before cannulation to 15 minutes after cannulation

    Change in SAI score from baseline measurement obtained 15 minutes before cannulation to measurement obtained 15 minutes after cannulation.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

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

Acronym: VirtualReality

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

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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