- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07639437
Preprocedural Video Education for Bronchoscopy Anxiety
Preprocedural Video Education for Anxiety Reduction in Patients Undergoing Bronchoscopy Under General Anesthesia: A Randomized Clinical Trial
The goal of this clinical trial is to learn whether preprocedural video education can reduce anxiety in adult patients who are scheduled to undergo bronchoscopy under general anesthesia. It will compare video-based education with standard verbal education.
The main questions it aims to answer are:
Does video education reduce preprocedural anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS), in patients undergoing bronchoscopy under general anesthesia?
Researchers will compare patients who receive audiovisual education with those who receive standard verbal education to see whether video education provides greater anxiety reduction before bronchoscopy under general anesthesia.
Participants will:
- Complete an APAIS questionnaire before receiving preprocedural education
- Receive either video-based education using a tablet or standard verbal education with a question-and-answer session
- Complete another APAIS questionnaire immediately after the education session
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Jakarta Special Capital Region
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Jakarta, Jakarta Special Capital Region, Indonesia, 13230
- RSUP Persahabatan
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients aged ≥18 years who are scheduled to undergo bronchoscopy under general anesthesia.
- Patients with no previous history of medical procedures performed under general anesthesia.
- Patients with an American Society of Anesthesiologists (ASA) physical status classification of I-III.
- Patients who are willing to participate in the study and have provided written informed consent.
Exclusion Criteria:
- Patients who are unable to read and write.
- Patients with significant hearing and/or visual impairment.
- Patients with cognitive or mental disorders identified from the patient's medical record.
- Patients with a history of antipsychotic or benzodiazepine use.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: control group
Participants in the control group received standard preprocedural education through verbal explanation and a question-and-answer session delivered by the anesthesiologist.
The education was based on the standard anesthesia education materials used at RSUP Persahabatan.
APAIS scores were assessed before and immediately after the education session.
|
Participants received standard preprocedural education through verbal explanation and a question-and-answer session delivered by the anesthesiologist.
The education was based on the standard anesthesia education materials used at RSUP Persahabatan and provided information about bronchoscopy under general anesthesia.
The APAIS questionnaire was completed before and immediately after the verbal education session.
|
|
Experimental: intervention group
Participants in the intervention group received standard preprocedural verbal education and a question-and-answer session delivered by the anesthesiologist.
In addition, they received audiovisual education through a video presented on a tablet.
The video provided information about bronchoscopy under general anesthesia.
APAIS scores were assessed before and immediately after the education session.
|
Participants received standard preprocedural verbal education and a question-and-answer session delivered by the anesthesiologist.
In addition, participants watched an audiovisual educational video about bronchoscopy under general anesthesia on a tablet.
The video was designed to provide consistent information about the procedure and anesthesia process, improve patient understanding, and reduce preprocedural anxiety.
The APAIS questionnaire was completed before and immediately after the education session.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pre-education total APAIS score
Periodo de tiempo: single time point immediately before education
|
The pre-education total APAIS score was assessed before any educational intervention was delivered, using the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
The APAIS consists of six items scored on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"), with higher total scores indicating greater preprocedural anxiety and information need.
|
single time point immediately before education
|
|
Post-education total APAIS score
Periodo de tiempo: single time point immediately after education
|
The pre-education total APAIS score was assessed before any educational intervention was delivered, using the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
The APAIS consists of six items scored on a 5-point Likert scale, ranging from 1 ("not at all") to 5 ("extremely"), with higher total scores indicating greater preprocedural anxiety and information need.
|
single time point immediately after education
|
Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 0045/KEPK-RSUPP/03/2025
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.
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