- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Elâzığ
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Elâzığ, Elâzığ, Turquie (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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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
- 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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control Group
Participants receive standard written informed consent and routine verbal anesthesia information according to routine clinical practice.
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Expérimental: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in APAIS Anxiety Score
Délai: Immediately before and immediately after completion of the information process (same study visit)
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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.
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Immediately before and immediately after completion of the information process (same study visit)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Information Comprehensibility Score
Délai: Immediately after completion of the information process
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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.
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Immediately after completion of the information process
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Patient Satisfaction Score
Délai: Immediately after completion of the information process
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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.
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Immediately after completion of the information process
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- QR Code-Based Video
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
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