Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

5 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

84

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Comparador activo: Control Group
Participants received routine postoperative care without any additional intervention
Participants received routine postoperative care without any additional intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in fatigue severity
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in pain intensity
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2025

Finalización primaria (Actual)

31 de enero de 2026

Finalización del estudio (Actual)

31 de enero de 2026

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

7 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir