- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07679659
Effect of a Preoperative Educational Video on Anxiety Levels (PEVA)
Effect of QR Code-Based and Tablet-Based Preoperative Educational Video Interventions on Preoperative Anxiety
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Preoperative anxiety is associated with adverse psychological and physiological responses and may negatively influence the perioperative experience. Educational interventions have been proposed as a practical strategy to improve patient understanding and reduce anxiety before surgery. Video-based education offers a standardized and accessible method for delivering information regarding anesthesia and surgical procedures.
Recent advances in digital health technologies have facilitated the use of mobile devices and QR code-based educational tools in routine clinical practice. However, evidence regarding the effectiveness of different modes of video delivery on preoperative anxiety remains limited.
This study will evaluate whether a brief educational video delivered through a QR code before the day of surgery or viewed on a tablet device immediately before surgery can reduce preoperative anxiety compared with standard care. In addition, the study will assess the feasibility and utilization of QR code-based patient education in the perioperative setting. The findings may contribute to the development of accessible and scalable patient education strategies aimed at improving the surgical experience and patient-centered care.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gülencan Yumuşak Ergin, MD
- Numéro de téléphone: +905373587055
- E-mail: gulencanyumusak@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Tuğba Açıkgöz
- Numéro de téléphone: +905334318062
- E-mail: gulencanyumusak@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 18 years or older.
- Scheduled for elective surgery under anesthesia.
- Able to understand Turkish.
- Able to provide written informed consent.
Exclusion Criteria:
- Emergency surgery.
- Visual or hearing impairment preventing video viewing.
- Cognitive impairment.
- Neurological or psychiatric disorders that may interfere with communication or completion of study questionnaires.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: QR Code Video Group
Participants will receive a QR code during the preoperative anesthesia clinic visit, allowing access to a brief educational video about anesthesia and surgery.
Participants may view the video on their own devices before the day of surgery.
|
Participants received a QR code providing access to the standardized preoperative educational video.
They were instructed to watch the video before surgery using their own smartphone or another internet-enabled device.
|
|
Expérimental: Tablet Video Group
Participants will watch the same educational video on a tablet device in the preoperative waiting area immediately before surgery.
|
Participants viewed the standardized preoperative educational video on a tablet device provided by the study staff in the preoperative waiting area before surgery.
|
|
Aucune intervention: Control Group
Participants will receive standard preoperative information and routine care without exposure to the educational video.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Amsterdam Preoperative Anxiety and Information Scale ( APAIS)
Délai: On the day of surgery, immediately before induction of anesthesia
|
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be used to assess preoperative anxiety and information requirement.
Scores range from 6 to 26, with higher scores indicating greater preoperative anxiety and information requirement (worse outcome).
|
On the day of surgery, immediately before induction of anesthesia
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
QR Code Utilization Rate
Délai: From enrollment until immediately before anesthesia induction on the day of surgery, assessed up to 1 month
|
The proportion of participants who accessed the educational video through the provided QR code before surgery.
|
From enrollment until immediately before anesthesia induction on the day of surgery, assessed up to 1 month
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Gülencan Yumuşak Ergin, MD, Aksaray University Training and Research Hospital
Publications et liens utiles
Publications générales
- Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
- Cetinkaya F, Kavuran E, Unal Aslan KS. Validity and reliability of the Amsterdam Preoperative Anxiety and Information Scale in the Turkish population. Turk J Med Sci. 2019 Feb 11;49(1):178-183. doi: 10.3906/sag-1806-84.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SAGETİK 2026-82
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .