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

30. maj 2026 opdateret af: KTO Karatay University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Virtual Reality Group
Patients receive VR during cannulation
Enhed: 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°.
Andre navne:
  • Virtual reality
Aktiv komparator: Control Group
Routine Procedure
Andet: Routine Procedure
Only the clinic's routine procedures were followed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity
Tidsramme: 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.
15 minutes after AVF cannulation
Anxiety Level
Tidsramme: 15 minutes after AVF cannulation
Anxiety levels will be assessed using the State Anxiety Inventory (SAI). Higher scores indicate higher anxiety levels.
15 minutes after AVF cannulation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity from BaselineBaseline Values"
Tidsramme: 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.
From 15 minutes before cannulation to 15 minutes after cannulation
Change in Anxiety Level from Baseline
Tidsramme: 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.
From 15 minutes before cannulation to 15 minutes after cannulation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

KTO Karatay University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. juli 2025

Primær færdiggørelse (Faktiske)

20. oktober 2025

Studieafslutning (Faktiske)

20. oktober 2025

Datoer for studieregistrering

Først indsendt

31. marts 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KTO Karatay University AVFSTL

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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