- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07647588
QR Code-Based Video-Supported Anesthesia Information and Preoperative Anxiety (QR-AID)
The Effect of QR Code-Based Video-Supported Anesthesia Information on Preoperative Anxiety, Comprehensibility of Information, and Patient Satisfaction: A Prospective Randomized Controlled Study
This study aims to evaluate the effects of QR code-based video-supported anesthesia information on preoperative anxiety, comprehensibility of information, and patient satisfaction in adult patients undergoing elective surgery.
Participants will be randomly assigned in a 1:1 ratio to either a control group receiving standard written informed consent and routine verbal anesthesia information or an intervention group receiving the same standard information plus a standardized video-based educational intervention accessed through a QR code.
The primary outcome is the change in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety score before and after the information process. Secondary outcomes include comprehensibility of information and patient satisfaction assessed using a structured Likert-type questionnaire.
The findings may contribute to the standardization of patient information processes in anesthesia outpatient clinics through a low-cost and easily implementable digital educational approach.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Informed consent and preoperative patient education are essential components of perioperative care. However, written consent forms may be difficult for some patients to understand because of technical language, limited consultation time, and variability in verbal explanations. Digital educational tools may provide standardized and more comprehensible information before surgery.
This single-center, prospective, parallel-group randomized controlled trial will evaluate whether QR code-based video-supported anesthesia information improves preoperative patient education compared with standard written informed consent and routine verbal anesthesia information. Adult patients scheduled for elective surgery will be randomized in a 1:1 ratio to either standard information alone or standard information plus access to a standardized educational video via QR code.
The video-supported intervention is designed to provide clear visual and auditory information about the anesthesia process, preparation before surgery, perioperative care, potential complications, common temporary side effects, patient rights, and the importance of informed consent. The study will assess whether this approach reduces preoperative anxiety and improves patients' understanding of anesthesia-related information and satisfaction with the information process.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Elâzığ
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Elâzığ, Elâzığ, Turquía (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective surgery
- Evaluated in the anesthesia outpatient clinic
- Able to understand the study information and questionnaires
- Able to provide written informed consent
Exclusion Criteria:
- Emergency surgery
- Impaired consciousness
- Advanced dementia
- Severe psychiatric illness
- Severe visual, hearing, or cognitive impairment
- Inability to understand the digital educational content
- Refusal to participate
- Inability to read or understand Turkish
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 standard written informed consent and routine verbal anesthesia information according to routine clinical practice.
|
|
|
Experimental: QR Video Group
Participants receive standard written informed consent and routine verbal anesthesia information plus a standardized QR code-based video-supported anesthesia education program.
|
Participants receive standard written informed consent and routine verbal anesthesia information plus a standardized QR code-based video-supported educational intervention.
The video includes information regarding anesthesia types, fasting requirements, perioperative preparation, potential complications, common side effects, patient rights, and informed consent.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in APAIS Anxiety Score
Periodo de tiempo: Immediately before and immediately after completion of the information process (same study visit)
|
Change in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety subscale score from before the information process (T1) to after completion of the information process (T2).
The APAIS anxiety subscale ranges from 4 to 20, with higher scores indicating greater preoperative anxiety.
|
Immediately before and immediately after completion of the information process (same study visit)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Information Comprehensibility Score
Periodo de tiempo: Immediately after completion of the information process
|
Comprehensibility of anesthesia information assessed using a structured 10-item Likert-type questionnaire.
Total scores range from 10 to 50, with higher scores indicating better understanding and comprehensibility of the information provided.
|
Immediately after completion of the information process
|
|
Patient Satisfaction Score
Periodo de tiempo: Immediately after completion of the information process
|
Patient satisfaction with the anesthesia information process assessed using a structured 10-item Likert-type questionnaire.
Total scores range from 10 to 50, with higher scores indicating greater satisfaction with the information process.
|
Immediately after completion of the information process
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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-Based Video
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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