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Virtual reality-baseret operationsstue Introduktion til reduktion af angst og kirurgisk frygt hos kirurgiske patienter

17. august 2026 opdateret af: Rana Güngör, Acibadem University

Effekten af ​​virtual reality-baseret operationsstue introduktion på angst, kirurgisk frygt og tilfredshed hos patienter med ortopædisk kirurgi

Kære deltager,

Denne undersøgelse har titlen "Effekten af ​​introduktion af operationsstuen ved hjælp af virtual reality -briller på angst, kirurgisk frygt og tilfredshedsniveauer hos patienter, der gennemgår ortopædisk kirurgi." Din deltagelse er helt frivillig, og at vælge ikke at deltage vil ikke påvirke din behandling eller omhu på nogen måde.

Formålet med denne undersøgelse er at evaluere virkningerne af introduktion af operationsstuen ved hjælp af virtual reality -briller på angst, kirurgisk frygt, postoperative smerteniveauer, fysiologiske parametre og patienttilfredshed hos patienter, der gennemgår ortopædisk kirurgi. Hvis resultaterne af undersøgelsen er positive, anbefales virtual reality-understøttede introduktionsmetoder som et effektivt uddannelsesværktøj til kirurgiske patienter.

I denne undersøgelse indsamles data gennem socio-demografisk information og flere spørgeskemaer (Patient Introduction Form, State-Trait Angst Inventory, Surgical Fear Scale, Numerical Rating Scale). Derudover måles dine fysiologiske parametre og elektrodermal aktivitet ved hjælp af overvågningsenheder, og du vil se en video, der introducerer operationsstue -miljøet med virtual reality -briller. Denne video dækker ikke selve den kirurgiske proces, men vil give generel information om overførslen til operationsstuen, operationsstue -miljøet og den postoperative serviceproces. Undersøgelsen begynder en dag før din operation og afsluttes inden din decharge.

De oplysninger, der blev opnået under denne undersøgelse, vil blive brugt i videnskabelig forskning uden at afsløre din identitet og vil blive holdt i overensstemmelse med fortrolighedsprincipper. Der vil ikke være nogen gebyr for din deltagelse i denne undersøgelse, og der vil heller ikke foretage nogen betaling til dig for din deltagelse.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse har til formål at evaluere virkningerne af en operationsstudstur, der udføres ved hjælp af virtual reality (VR) -briller på angst, kirurgisk frygt, postoperativ smerte, tilfredshedsniveauer og fysiologiske parametre hos patienter, der gennemgår ortopædisk kirurgi.

Interventionen vil involvere en 3D -uddannelsesvideo, der introducerer operationsstue -miljøet, kirurgiske teamroller og forventet patientoplevelse i den perioperative periode. Denne video præsenteres ved hjælp af Meta Quest 3 VR -beskyttelsesbriller. Deltagere i interventionsgruppen vil se denne video inden operationen, mens kontrolgruppen vil modtage standard præoperativ uddannelse.

De primære resultater inkluderer ændringer i præoperativ angst (STAI-I), kirurgisk frygt (kirurgisk frygtskala) og fysiologiske parametre (f.eks. Hjertefrekvens, blodtryk og elektrodermal aktivitet). Sekundære resultater inkluderer postoperativ smerte og patienttilfredshed. Data indsamles på flere tidspunkter, herunder før og efter interventionen, på operationens dag og i den postoperative periode.

Undersøgelsen er designet som et randomiseret kontrolleret forsøg med en prøvestørrelse på 60 deltagere, der er lige fordelt mellem interventions- og kontrolgrupper. Dataanalyse vil omfatte passende statistiske tests baseret på variabel distribution og gruppesammenligninger.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

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)
    • Ataşehir
      • Istanbul, Ataşehir, Tyrkiet (Türkiye), 34642
        • Acibadem Atasehir Hospitla
    • ataşehir
      • Istanbul, ataşehir, Tyrkiet (Türkiye), 34662
        • Acibadem Altunizade Hospital

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

Inkluderingskriterier:

  • Enkeltpersoner i alderen 18-65 år
  • Patienter, der er planlagt til artroskopisk kirurgi
  • De, der ikke har gennemgået nogen tidligere kirurgiske procedurer
  • Patienter, der vil gennemgå operation under generel anæstesi
  • Enkeltpersoner uden kommunikationsbarrierer
  • Patienter med klar bevidsthed og orientering til person, sted og tid
  • Dem uden neurologiske eller psykiatriske lidelser
  • Personer uden alvorlige visuelle eller auditive svækkelser

Ekskluderingskriterier:

  • Manglende evne til at kommunikere med patienterne
  • Udvikling af et livstruende sundhedsproblem efter operation
  • Overgang til åben kirurgi under proceduren
  • Patienter, der ønsker at trække sig ud af undersøgelsen

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Virtual reality-baseret uddannelsesgruppe
Adfærdsmæssigt: Virtual Reality-Based Operating Room Education

For the Intervention Group:

The intervention consisted of a researcher-developed 360-degree virtual reality operating room education video. The 9-minute 22-second video was recorded from the patient's perspective using an Insta360 X4 camera and presented with Meta Quest 3 VR headsets. It included transfer from the ward, handover to the surgical team, transfer to the operating table, safety and monitoring, anesthesia induction, emergence from anesthesia, and transfer to the ward. At relevant points, perioperative information was provided through researcher-prepared voice-over narration integrated into the video. Participants watched the video once on an examination bed/stretcher in examination rooms, positioned at approximately 30-45 degrees with a pillow under the head. A disposable hygienic headset strap cover was used. The same device, procedure, and video were used. The VR education was provided in addition to the institution's standard preoperative education.

Andre navne:
  • VR-baseret operationsstueorientering
  • Virtual reality kirurgisk miljøuddannelse
Ingen indgriben: Standarduddannelsesgruppe

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Preoperative anxiety level: State Anxiety - State-Trait Anxiety Inventory (STAI-I)
Tidsramme: STAI-I was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and within 2 hours after surgery.
State anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-I). The STAI-I consists of 20 items rated on a 4-point Likert-type scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.
STAI-I was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and within 2 hours after surgery.
Patient satisfaction with perioperative care
Tidsramme: Satisfaction will be measured within 2 hours after discharge procedures have started.
Patient satisfaction with perioperative care will be assessed using a 10-point satisfaction scale. Scores range from 1 to 10, with higher scores indicating higher satisfaction.
Satisfaction will be measured within 2 hours after discharge procedures have started.
Surgical fear level: Surgical Fear Questionnaire (SFQ)
Tidsramme: Surgical fear was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; and on the day of surgery, before surgery.
Surgical fear was assessed using the Surgical Fear Questionnaire (SFQ). The SFQ consists of 8 items rated on an 11-point scale from 0 (not afraid at all) to 10 (very afraid). The total score ranges from 0 to 80, with higher scores indicating greater surgical fear.
Surgical fear was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; and on the day of surgery, before surgery.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative pain level: Numeric Rating Scale (NRS)
Tidsramme: Postoperative pain was assessed within 2 hours after surgery.

This measure compared postoperative pain levels between the virtual reality education and standard education groups. Pain level was assessed using the Numerical Rating Scale (NRS).

Minimum Value: 0 (No Pain) Maximum Value: 10 (Worst Pain) Higher Scores: Indicate worse outcomes, meaning more severe pain.
Postoperative pain was assessed within 2 hours after surgery.
Physiological parameters: Heart rate
Tidsramme: Heart rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Heart rate was assessed in the intervention and control groups.
Heart rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Electrodermal activity (EDA)
Tidsramme: Before and after the intervention (3 min each), on the morning of surgery before transfer (3 min), and continuously during ward-to-OR transfer, from transfer start to handover completion.
Electrodermal activity (EDA) was assessed to evaluate physiological arousal in the intervention and control groups. EDA was recorded using a Shimmer3 GSR+ device.
Before and after the intervention (3 min each), on the morning of surgery before transfer (3 min), and continuously during ward-to-OR transfer, from transfer start to handover completion.
Physiological parameters: Systolic blood pressure
Tidsramme: Systolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Systolic blood pressure was assessed in the intervention and control groups.
Systolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Physiological parameters: Diastolic blood pressure
Tidsramme: Diastolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Diastolic blood pressure was assessed in the intervention and control groups.
Diastolic blood pressure was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Physiological parameters: Respiratory rate
Tidsramme: Respiratory rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Respiratory rate was assessed in the intervention and control groups.
Respiratory rate was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Physiological parameters: Peripheral oxygen saturation (SpO₂)
Tidsramme: Peripheral oxygen saturation (SpO₂) was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Peripheral oxygen saturation (SpO₂) was assessed in the intervention and control groups.
Peripheral oxygen saturation (SpO₂) was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Physiological parameters: Body temperature
Tidsramme: Body temperature was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.
Body temperature was assessed in the intervention and control groups.
Body temperature was assessed 24-48 hours before surgery, before the intervention; immediately after the intervention; on the day of surgery, before surgery; and at the first and second hours after admission to the inpatient ward.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trait anxiety level: State-Trait Anxiety Inventory (STAI-II)
Tidsramme: 24-48 hours before surgery, prior to the intervention/education.
Trait anxiety was assessed using the STAI-II subscale of the State-Trait Anxiety Inventory. The STAI-II consists of 20 items scored on a 4-point Likert-type scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of trait anxiety.
24-48 hours before surgery, prior to the intervention/education.

Samarbejdspartnere og efterforskere

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

Sponsor

Acibadem University

Samarbejdspartnere

Acibadem Altunizade Hospital, Istanbul
Acibadem Atasehir Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

7. juli 2025

Primær færdiggørelse (Faktiske)

25. oktober 2025

Studieafslutning (Faktiske)

25. oktober 2025

Datoer for studieregistrering

Først indsendt

19. marts 2025

Først indsendt, der opfyldte QC-kriterier

25. marts 2025

Først opslået (Faktiske)

2. april 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ORTO2025-VR01

Plan for individuelle deltagerdata (IPD)

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JA

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Vi planlægger at dele dataene gennem åben adgang i det relevante tidsskrift efter anonymisering af dataene. Ingen personligt identificerbare oplysninger vil blive inkluderet, og kun anonyme data vil blive delt. Vi planlægger at gøre dataene tilgængelige på tidsskriftets dataplatform efter undersøgelsesdatoen for undersøgelsen.

IPD-delingstidsramme

Startdato: 01.01.2026 (når publikationsprocessen begynder) Slutdato: 01.07.2026 (6 måneder efter offentliggørelse)

IPD-delingsadgangskriterier

De-identified individual participant data and supporting information will be available to qualified researchers upon reasonable request for scientifically valid research purposes. Requests will be reviewed by the principal investigator and will be subject to ethical and data protection requirements. Data will be provided after approval of the request and, where applicable, completion of a data access agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

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