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Effect of Virtual Reality During Femoral Sheath Removal

11. juni 2026 oppdatert av: İrem Canavar, Hasan Kalyoncu University

The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial

This randomized controlled study was conducted to evaluate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were assigned to either a virtual reality intervention group or a control group receiving standard care. Pain, anxiety, and vital signs were assessed before, during, and after the procedure. The study aimed to determine whether virtual reality application could improve patient comfort and reduce procedure-related discomfort during femoral sheath removal.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.

Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.

This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.

The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Hatay
      • İskenderun, Hatay, Tyrkia (Türkiye)
        • İskenderun Devlet Hastanesi

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Patients aged 18 years and older
  • Patients undergoing percutaneous coronary intervention via femoral access
  • Patients with only one femoral sheath catheter
  • Patients who did not receive analgesic medication before sheath removal
  • Patients without severe hemorrhage or major hematoma at the femoral sheath site
  • Patients able to communicate in Turkish
  • Patients without visual, hearing, or speech impairment
  • Patients without mental impairment affecting communication
  • Patients without psychiatric diagnosis and not using psychiatric medication

Exclusion Criteria:

  • Patients unwilling to participate or wishing to withdraw from the study at any stage

    • Patients who removed the virtual reality glasses during the intervention
    • Patients who experienced intolerance to virtual reality application (e.g., dizziness or nausea)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Virtual Reality Group
Participants received virtual reality glasses during femoral sheath removal
Enhet: Virtual Reality
Virtual reality glasses were used during femoral sheath removal.
Annen: Control Group
Participants received routine care during femoral sheath removal
Annen: Routine Care
Participants received routine care during femoral sheath removal

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart Rate
Tidsramme: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Heart rate was measured in beats per minute using routine monitoring.
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Blood Pressure
Tidsramme: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Oxygen Saturation
Tidsramme: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Oxygen saturation was measured as percent saturation using pulse oximetry.
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
Body Temperature
Tidsramme: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Body temperature was assessed using routine vital sign monitoring.
5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Pain Level
Tidsramme: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Pain level was assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain severity.
5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
Anxiety Level
Tidsramme: Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
Anxiety level was assessed using the State Anxiety Inventory (STAI). Higher scores indicate higher anxiety levels.
Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hasan Kalyoncu University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2025

Primær fullføring (Faktiske)

5. januar 2026

Studiet fullført (Faktiske)

5. januar 2026

Datoer for studieregistrering

Først innsendt

8. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HKU-2025/069

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared due to privacy and confidentiality considerations

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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