Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effects of Virtual Reality After Liver Transplantation (VR-LT)

5. mai 2026 oppdatert av: Bilsev DEMIR, Malatya Turgut Ozal University

Effects of Virtual Reality on Pain, Fatigue and Vital Signs After Liver Transplantation A Randomized Controlled Trial

This randomized controlled study aims to evaluate the effects of a virtual reality intervention on pain, fatigue and vital signs in patients during the early postoperative period after liver transplantation. Postoperative symptoms such as pain and fatigue may negatively affect recovery and patient comfort. Virtual reality has emerged as a non-pharmacological method that may help reduce these symptoms by providing distraction and relaxation.

A total of 84 patients were randomly assigned to an experimental group or a control group. The experimental group received a 20-minute virtual reality session, while the control group received standard care. Pain, fatigue and vital signs were measured before and after the intervention.

This study aims to determine whether virtual reality can improve patient comfort and physiological stability and support recovery after liver transplantation.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study was designed as a prospective, randomized controlled, single-blind trial to evaluate the effects of a virtual reality intervention on pain, fatigue, and vital signs in patients during the early postoperative period after liver transplantation.

Liver transplantation is a life-saving procedure; however, patients frequently experience postoperative symptoms such as pain and fatigue, which may negatively affect recovery, physiological stability, and overall patient comfort. Non-pharmacological interventions have gained increasing attention in recent years as supportive approaches to improve postoperative outcomes. Virtual reality is an emerging technology that provides immersive distraction and relaxation, potentially reducing symptom perception and enhancing patient well-being.

The study was conducted in the organ transplantation clinic of a university hospital between May 2025 and January 2026. A total of 84 patients who met the inclusion criteria were randomly assigned to either the experimental group (n=42) or the control group (n=42) using a computer-based randomization method.

Patients in the experimental group received a 20-minute virtual reality intervention during the early postoperative period, while patients in the control group received standard care without additional intervention. Pain levels were assessed using the Numerical Rating Scale (NRS), fatigue levels were measured using the Brief Fatigue Inventory (BFI), and vital signs including heart rate, respiratory rate, and blood pressure were recorded. All measurements were obtained before the intervention and 15 minutes after the intervention.

The primary objective of the study was to determine the effect of virtual reality on fatigue levels. Secondary outcomes included pain and vital signs. Data were analysed using appropriate statistical methods, and statistical significance was set at p<0.05.

This study aims to contribute to the evidence base regarding the effectiveness of virtual reality as a non-pharmacological nursing intervention and to support its integration into clinical practice to improve postoperative care in liver transplantation patients.

Studietype

Intervensjonell

Registrering (Faktiske)

84

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)
      • Malatya, Tyrkia (Türkiye)
        • Inonu University Liver Transplantation Institute

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:

  • Age ≥18 years
  • Underwent liver transplantation
  • In the early postoperative period
  • Able to communicate verbally
  • No diagnosed psychiatric disorder
  • Hemodynamically stable
  • Pain score ≥4 on the Numerical Rating Scale (NRS)
  • Willing to participate in the study

Exclusion Criteria:

  • Presence of severe postoperative complications
  • Cognitive impairment or inability to understand instructions
  • Visual or hearing impairments preventing use of virtual reality
  • History of motion sickness or vertigo related to virtual reality use
  • Chronic diseases that may affect fatigue or vital signs (e.g., uncontrolled cardiovascular or respiratory diseases)
  • Refusal to participate

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: Experimental Group
Participants received a 20 minute virtual reality intervention during the early postoperative period following liver transplantation. The intervention was administered using a head mounted display and aimed to reduce fatigue and improve physiological parameters
Atferdsmessig: Virtual Reality Intervention
A 20 minute immersive virtual reality session was administered using a headmounted display during the early postoperative period following liver transplantation.
Aktiv komparator: Control Group
Participants received routine postoperative care without any additional intervention
Annen: Standard Care
Participants received routine postoperative care without any additional intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in fatigue severity
Tidsramme: Baseline and 15 minutes after intervention
Change in fatigue severity measured using the Brief Fatigue Inventory (BFI) total score (range: 0-10; higher scores indicate greater fatigue)
Baseline and 15 minutes after intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in pain intensity
Tidsramme: Baseline and 15 minutes after intervention
Measured using the Numerical Rating Scale (NRS) (range: 0-10; higher scores indicate greater pain)
Baseline and 15 minutes after intervention
Change in heart rate (beats per minute)
Tidsramme: Baseline and 15 minutes after intervention
Change in heart rate measured in beats per minute (bpm). Heart rate was recorded as part of routine vital sign monitoring to evaluate the physiological response to the virtual reality intervention. Lower values may indicate improved relaxation and autonomic stability.
Baseline and 15 minutes after intervention
Change in systolic and diastolic blood pressure (mmHg)
Tidsramme: Baseline and 15 minutes after intervention
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg). Blood pressure was recorded as part of routine vital sign monitoring to evaluate the cardiovascular response to the virtual reality intervention. Lower values may indicate improved physiological stability and relaxation.
Baseline and 15 minutes after intervention
Change in systolic and diastolic blood pressure (mmHg)
Tidsramme: Baseline and 15 minutes after intervention
Change in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg). Blood pressure was assessed as part of routine vital sign monitoring to evaluate the cardiovascular response to the intervention. Lower values may indicate improved physiological stability.
Baseline and 15 minutes after intervention

Samarbeidspartnere og etterforskere

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

Sponsor

Malatya Turgut Ozal 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. mai 2025

Primær fullføring (Faktiske)

31. januar 2026

Studiet fullført (Faktiske)

31. januar 2026

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25H04 (Annet stipend/finansieringsnummer: Malatya Turgut Ozal University Scientific Research Projects Unit)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere