NCT07622264

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

March 31, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

HemodialysisVirtual RealityPainState Anxiety

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in Pain Intensity from BaselineBaseline Values"

    From 15 minutes before cannulation to 15 minutes after cannulation

  • Change in Anxiety Level from Baseline

    From 15 minutes before cannulation to 15 minutes after cannulation

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Patients receive VR during cannulation

Device: Virtual Reality Group

Control Group

ACTIVE COMPARATOR

Routine Procedure

Other: Routine Procedure

Interventions

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°.

Also known as: Virtual Reality
Virtual Reality Group

Only the clinic's routine procedures were followed.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daviva Private Konya Dialysis Center

Konya, Selçuklu, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arteriovenous FistulaPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

June 3, 2026

Study Start

July 20, 2025

Primary Completion

October 20, 2025

Study Completion

October 20, 2025

Last Updated

June 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations