- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07660705
QR Code Video Education for ICU Family Members (QR-ICU)
Effect of a QR Code-Based Digital Information Video on Knowledge and Anxiety Among Family Members of Intensive Care Unit Patients: A Prospective Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Family members of patients admitted to intensive care units frequently experience anxiety, uncertainty, and a need for information regarding the patient's condition and ICU procedures. Conventional verbal information may vary depending on time constraints, workload, and communication practices, resulting in inconsistent delivery of information.
This prospective randomized controlled trial will investigate whether a standardized QR code-based digital information video can improve knowledge and reduce anxiety among family members of ICU patients. Eligible first-degree relatives of ICU patients will be randomized into two groups. The control group will receive routine verbal information according to standard clinical practice. The intervention group will receive routine verbal information in addition to access to a QR code-based educational video.
The educational video will provide information regarding the ICU environment, monitoring systems, mechanical ventilation, sedation practices, common procedures, visiting policies, and frequently encountered clinical situations. The video is designed to provide standardized, understandable, and easily accessible information.
The primary outcome will be the total score of the Information Adequacy and Comprehensibility Questionnaire. Secondary outcomes will include anxiety scores measured using the Visual Analog Scale for Anxiety (VAS-A), satisfaction with information, and participant-reported adequacy of answers to their information needs. Assessments will be performed at baseline, within 24 hours after the intervention, and 72 hours after enrollment.
A total of 150 participants will be enrolled. The study is conducted at Elazig Fethi Sekin City Hospital.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sevim Şenol Karataş, MD
- Número de teléfono: +905325736611
- Correo electrónico: drsevimkaratas@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Sait F Öner, MD
- Número de teléfono: +90 533 627 13 58
- Correo electrónico: sfatihoner@gmail.com
Ubicaciones de estudio
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Merkez
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Elâzığ, Merkez, Turquía (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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Contacto:
- Sevim Şenol Karataş, MD
- Número de teléfono: +905325736611
- Correo electrónico: drsevimkaratas@gmail.com
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Investigador principal:
- Sevim Şenol Karataş, MD
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Contacto:
- Sait F Öner, MD
- Número de teléfono: +90 533 627 13 58
- Correo electrónico: sfatihoner@gmail.com
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Sub-Investigador:
- Sait F Öner, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- First-degree family member of a patient admitted to the intensive care unit
- Able to read and understand Turkish
- Able to use a smartphone
- Able to access QR code-based educational materials
- Willing to participate and provide written informed consent
Exclusion Criteria:
- History of a diagnosed psychiatric disorder
- Current use of anxiolytic or antidepressant medication
- Visual or hearing impairment preventing participation in video-based education
- First-degree family member who is an active healthcare professional involved in patient care
- Inability to complete study questionnaires or follow-up assessments
- Refusal to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control Group
Participants receive routine verbal information regarding the intensive care unit and the patient's clinical condition according to standard clinical practice.
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Experimental: QR Video Group
Participants receive routine verbal information in addition to access to a standardized QR code-based digital educational video about the intensive care unit, monitoring systems, mechanical ventilation, sedation, and common ICU procedures.
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A standardized QR code-based educational video providing information about the intensive care unit environment, monitoring systems, mechanical ventilation, sedation practices, visiting policies, and frequently encountered clinical situations.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Information Adequacy and Comprehensibility Questionnaire Total Score
Periodo de tiempo: 72 hours after enrollment
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Total score of the Information Adequacy and Comprehensibility Questionnaire, a 15-item Likert-type questionnaire developed for this study.
Scores range from 15 to 75, with higher scores indicating better understanding and perceived adequacy of information.
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72 hours after enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety Score Measured by Visual Analog Scale for Anxiety (VAS-A)
Periodo de tiempo: 72 hours after enrollment
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Participant-reported anxiety measured using a 0-10 Visual Analog Scale for Anxiety (VAS-A), where higher scores indicate greater anxiety.
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72 hours after enrollment
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Information Satisfaction Score
Periodo de tiempo: 72 hours after enrollment
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Participant satisfaction with information provided during the intensive care unit stay, measured using a 0-10 visual analog scale, with higher scores indicating greater satisfaction.
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72 hours after enrollment
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Resolution of Participant Information Needs
Periodo de tiempo: 72 hours after enrollment
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Participants rate the extent to which their most important information needs and questions were answered using a 0-10 scale, with higher scores indicating better resolution of information needs.
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72 hours after enrollment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sevim Şenol Karataş, MD, Elazıg Fethi Sekin Sehir Hastanesi
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
- QR Code-Family
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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