- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07576920
Anxiety Levels in Living Liver Donors
Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Liver transplantation is the only treatment for end-stage liver disease. The shortage of organ donations is leading clinicians to increasingly perform transplants from living donors. The biggest concern in living-donor liver transplantation is donor safety.
Liver donors undergo a major surgical operation that offers no medical benefit to them. The procedure can involve not only a physical but also a psychological burden. Given this situation, protecting both the physical and psychological health of liver donors is essential.
Anxiety studies primarily focus on organ transplant recipients However, the quality of life of donors and psychological conditions such as anxiety and depression are attracting increasing attention in the field of organ transplantation today. Neuropsychiatric Disease and Treatment 2018:14 1999-2005 A literature review revealed that there are limited studies investigating how donors are affected during the transplantation process in living-donor liver transplantation.
The aim of our study is to determine the preoperative and postoperative anxiety levels of donors in living donor liver transplantation and to identify possible conditions that may be associated with anxiety.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zekine Begeç, Professor
- Número de teléfono: 3112 +904223410660
- Correo electrónico: zekine.begec@inonu.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Muharrem Uçar, Professor
- Número de teléfono: 3112 +904223410660
- Correo electrónico: umuharrem@hotmail.com
Ubicaciones de estudio
-
-
-
Malatya, Turquía (Türkiye)
- Reclutamiento
- Turgut Ozal Medical Center
-
Investigador principal:
- Zekine Begec
-
Contacto:
- Zekine Begec, Dr
- Número de teléfono: +904223410660
- Correo electrónico: zekine.begec@inonu.edu.tr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- ASA 1-2 group patients aged 18-65 years who are liver transplant donors
Exclusion Criteria:
- Patients with communication problems, those who are illiterate,
- Patients do not have sufficient time for the tests,
- Patients using sedatives, antidepressants, or antiepileptic drugs,
- Patients with cerebrovascular or psychiatric diseases,
- Patients with alcohol or substance addiction,
- Patients who do not want or cannot undergo the second test
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Living liver donors
Liver transplant donors who will undergo surgery between May and July 2026
|
Anxiety scores will evaluated STAI test.
The STAI test consists of two sections of 20 questions each.
The first section of the test includes questions about how the person feels at that moment.
Answers are given on a scale of 4 points.
For example: I am calm right now: not at all=1, a little=2, a lot=3, completely=4.
The second section of the test includes questions about how the person feels in general and is also answered on a scale of 4 points.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety Scores
Periodo de tiempo: From 24 hours prior to the operation to postoperative 3. day and 7. day
|
The STAI test is a questionnaire comprising two, 20-item scales used to measure state and trait anxiety.
The anxiety levels of LLDs will be evaluated by using the STAI.
The STAI-State (STAI-S) form will be use to measure the current anxiety level.
The test includes questions about how the person feels at that moment.
Answers are given on a scale of 4 points.
For example: I am calm right now: not at all=1, a little=2, a lot=3, completely=4.
The STAI-Trait (STAI-T) form will be use to measure the underlying (ongoing/personality) anxiety level of the patient.
The test includes questions about how the person feels in general and is also answered on a scale of 4 points.
Each patient will complete these forms preoperatively and postoperatively.
The mean (total) score on the STAI has a minimum of 20 and a maximum of 80.
The STAI scores are generally classified as no anxiety or low anxiety (score of 20-37), moderate anxiety (score of 38-44), and high anxiety (score of 45-80).
|
From 24 hours prior to the operation to postoperative 3. day and 7. day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Presence of an alternative donor
Periodo de tiempo: Prior to the operation
|
The relationship between the presence or absence of an alternative donor and donors anxiety scores will be evaluated.
This will be defined as "alternative donor available" or "alternative donor not available."
|
Prior to the operation
|
|
Recipient Prognosis
Periodo de tiempo: at the postoperative 3. day and 7. day
|
The relationship between the recipients prognosis and donors anxiety scores will be evaluated.
This will be defined as the recipient living or not living
|
at the postoperative 3. day and 7. day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zekine Begeç, professor, Inonu University Department of Anesthesia
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Anxiety
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .