- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Jakarta Special Capital Region
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Jakarta, Jakarta Special Capital Region, Indonésia, 13230
- RSUP Persahabatan
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pre-education total APAIS score
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 0045/KEPK-RSUPP/03/2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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