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- Ensayo clínico NCT07604389
AR Health Education Video for Postoperative Breast Cancer Patients (AR-BCS)
Effects of AR Health Education Video Intervention on Anxiety and Depression in Postoperative Breast Cancer Patients
Breast cancer surgery patients may experience anxiety and depression before and after surgery. Health education can help patients understand the surgical process and postoperative care, but traditional education may not always be easy to understand.
This study evaluates whether augmented reality (AR) health education videos can help reduce anxiety and depression in postoperative breast cancer patients. Participants are randomly assigned to one of two groups. One group receives routine health education plus AR health education videos, and the other group receives routine health education only.
The study compares changes in anxiety, depression, and selected physiological indicators between the two groups before and after surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized controlled study. Eligible breast cancer surgery patients are randomly assigned to an AR health education group or a routine health education group.
Participants in the AR health education group receive routine perioperative health education plus AR health education videos. Participants in the routine health education group receive routine perioperative health education only.
An outcome assessor who is blinded to group allocation collects questionnaire data before surgery, on postoperative day 1, and on postoperative day 2. Anxiety is measured using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), and depression is measured using the Beck Depression Inventory-II (BDI-II). Physiological indicators, including heart rate, respiratory rate, blood pressure, and oxygen saturation, are also collected.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taichung City
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Taichung, Taichung City, Taiwán, 435
- Reclutamiento
- Tungs' Taichung MetroHarbor Hospital
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Contacto:
- Hsin-Hua Chen, RN, MSN
- Número de teléfono: +886919090022
- Correo electrónico: yugagn@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Female patients aged 18 years or older with breast cancer.
- Breast cancer confirmed by pathological examination.
- Conscious and able to communicate in Mandarin or Taiwanese.
- No visual or hearing impairment.
- Willing to participate in this study and provide informed consent.
Exclusion Criteria:
- Patients with brain metastasis, dementia, or cognitive impairment.
- Patients currently taking antidepressants, anxiolytics, or other psychiatric medications.
- Patients diagnosed with psychiatric disorders.
- Patients with a history of hypertension.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AR Health Education Group
Participants receive routine perioperative health education in addition to augmented reality (AR) health education videos related to breast cancer surgery and postoperative care.
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An augmented reality (AR)-based health education video designed to provide perioperative education, postoperative recovery guidance, daily activity adjustment, and self-care information for breast cancer surgery patients.
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Comparador activo: Routine Health Education Group
Routine perioperative health education provided according to standard clinical nursing care procedures.
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Routine perioperative health education provided according to standard clinical nursing care procedures.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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State Anxiety
Periodo de tiempo: Baseline, postoperative day 1, and postoperative day 2
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State anxiety is measured using the Chinese version of the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S).
The STAI-S includes 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.
Scores of 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and 60 to 80 indicate severe anxiety.
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Baseline, postoperative day 1, and postoperative day 2
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression
Periodo de tiempo: Baseline, postoperative day 1, and postoperative day 2
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Depression is measured using the Chinese version of the Beck Depression Inventory-II (BDI-II).
The BDI-II includes 21 items rated from 0 to 3, with total scores ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
Scores of 0 to 16 indicate normal range, 17 to 22 indicate mild depression, 23 to 30 indicate moderate depression, and 31 to 63 indicate severe depression.
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Baseline, postoperative day 1, and postoperative day 2
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Physiological Indicators
Periodo de tiempo: Baseline, postoperative day 1, and postoperative day 2
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Physiological indicators include heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, and peripheral oxygen saturation.
These indicators are collected to assess physiological responses related to anxiety during the perioperative period.
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Baseline, postoperative day 1, and postoperative day 2
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
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
- TTMHH-R1140011 (Otro identificador: Research Department, Tungs' Taichung MetroHarbor Hospital)
- 113090 (Otro identificador: Institutional Review Board of Tungs' Taichung MetroHarbor Hospital)
Plan de datos de participantes individuales (IPD)
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Descripción del plan 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.
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