- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Jakarta Special Capital Region
-
Jakarta, Jakarta Special Capital Region, Indonésie, 13230
- RSUP Persahabatan
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pre-education total APAIS score
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 0045/KEPK-RSUPP/03/2025
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Verbal only
-
Loma Linda UniversityDokončenoHemiplegie a/nebo hemiparéza po mrtviciSpojené státy
-
Chelsea and Westminster NHS Foundation TrustImperial College Healthcare NHS Trust; University of WestminsterDokončenoZávažné zraněníSpojené království
-
Centre hospitalier de l'Université de Montréal...Dokončeno