Standardized Patient Education in Pituitary Surgery
24 de mayo de 2026 actualizado por: AKİF BULUT, Uludag University
The Impact of Standardized Patient Education on Patient Outcomes in Transsphenoidal Pituitary Surgery
Protocols are being developed and implemented to ensure the best possible recovery process for patients undergoing transsphenoidal surgery, and their impact on patient outcomes is being evaluated. In studies where perioperative protocols-including patient education (verbal and written instruction on dehydration, hyponatremia, adrenal insufficiency, CSF leakage, meningitis, and the signs and symptoms of visual or other neurological disorders)-are implemented, it has been reported that patients' length of hospital stay is reduced, the rate of patients experiencing hyponatremia has decreased, and readmissions have declined (Sanchez-Garavito et al., 2024; Sarris et al., 2021). However, since these studies included protocols covering the entire surgical process-not just patient education-it is difficult to determine whether changes in patient outcomes stem from patient education or from alterations in other parameters within the protocol.
Therefore, in the clinic where this study will be conducted, the effect of patient education on postoperative patient outcomes will be examined by developing an educational material that standardizes patient education, without making any changes to the surgical or pharmacological processes.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
102
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.
Estudio Contacto
- Nombre: AKİF BULUT, PhD
- Número de teléfono: +905468722872
- Correo electrónico: akifblt23@gmail.com
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:
- Admitted for elective surgery due to a pituitary tumor.
- Has not previously undergone surgery for the same medical condition.
- Has voluntarily agreed to participate in the study.
- Has no missing medical data.
- Can speak Turkish or understand what is being explained.
- Patients aged 18 and older.
Exclusion Criteria:
- Emergency surgery will be performed.
- Revision surgery will be performed.
- Those who voluntarily decline to participate in the study.
- Those with incomplete medical data.
- Those who cannot speak or understand Turkish.
- Patients under the age of 18.
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: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Education group
The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery.
The educational material and the sources used to create it are included in the appendix.
Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material.
Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver.
Additionally, the material will be posted in a clearly visible location in the patient's room.
|
The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery.
The educational material and the sources used to create it are included in the appendix.
Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material.
Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver.
Additionally, the material will be posted in a clearly visible location in the patient's room.
|
|
Sin intervención: Control group
The control group for this study will consist of former patients who underwent pituitary surgery at the Neurosurgery Clinic prior to the start of this scientific study.
Routine post-operative care at the clinic following pituitary surgery is as follows: patients who have undergone pituitary surgery are provided with information about the surgical process by the attending physician prior to surgery, and their voluntary written consent is obtained.
After surgery, the physician, resident, and nurse provide verbal instructions to the patient regarding constipation and precautions related to the nose; however, no standardized written educational materials are used.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The total time from admission to discharge for patients who received standardized patient education in transsphenoidal pituitary surgery
Periodo de tiempo: "From the registration phase through to the end of the 52-week training program"
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"From the registration phase through to the end of the 52-week training program"
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Complication rates (meningitis, hyponatremia, CSF leak) and rates of unplanned readmission among patients who received standardized training in transsphenoidal pituitary surgery during their hospital stay.
Periodo de tiempo: From the registration phase through to the end of the 52-week training program
|
From the registration phase through to the end of the 52-week training program
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Neoplasias por sitio
- Neoplasias
- Neoplasias de glándulas endocrinas
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Enfermedades hipotalámicas
- Neoplasias hipotalámicas
- Neoplasias Supratentoriales
- Neoplasias Cerebrales
- Enfermedades de la pituitaria
- Neoplasias hipofisarias
Otros números de identificación del estudio
- 2026-8/11
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Due to the ethics committee's decision regarding the conduct of the study, the data will not be publicly disclosed.
However, the data will be shared if a reasonable justification is provided.
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. .