- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07572305
Effects of Virtual Reality After Liver Transplantation (VR-LT)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Malatya, Turecko (Türkiye)
- Inonu University Liver Transplantation Institute
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
A 20 minute immersive virtual reality session was administered using a headmounted display during the early postoperative period following liver transplantation.
|
|
Aktivní komparátor: Control Group
Participants received routine postoperative care without any additional intervention
|
Participants received routine postoperative care without any additional intervention
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in fatigue severity
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in pain intensity
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25H04 (Jiné číslo grantu/financování: Malatya Turgut Ozal University Scientific Research Projects Unit)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Virtual Reality Intervention
-
University of BaselSwiss National Science Foundation; Universitäre Psychiatrische Kliniken (UPK)... a další spolupracovníciZatím nenabíráme
-
Assistance Publique - Hôpitaux de ParisZatím nenabíráme
-
Swiss Paraplegic Research, NottwilNáborPoranění míchy (SCI) | Neuropatická bolest způsobená poraněním míchyŠvýcarsko
-
University of Colorado, DenverSan Diego State University; University of Kansas Medical CenterNáborHPV infekce | Preventivní zdravotní službySpojené státy
-
Berker OkayNáborStres, psychologický | Úzkost | StrachTurecko (Türkiye)
-
Martini-Klinik am UKE GmbHNáborRakovina prostaty (adenokarcinom)Německo
-
Johns Hopkins UniversityItamar-Medical, Israel; Apple Inc.; Pharmaceutical Research & Manufacturers Of...NáborFibrilace síní | ChováníSpojené státy
-
Johns Hopkins UniversityDokončenoFibrilace síní | ChováníSpojené státy
-
Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de BarcelonaNáborFibromyalgieŠpanělsko
-
Consorci Sanitari de TerrassaNáborMetabolický syndromŠpanělsko