- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Background:
Informed consent and patient information 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 variations in verbal explanations provided by clinicians. Digital educational tools may improve patient understanding and reduce preoperative anxiety by providing standardized information.
Objective:
The primary objective of this randomized controlled trial is to determine whether QR code-based video-supported anesthesia information reduces preoperative anxiety compared with standard written and verbal information alone.
Methods:
This is a single-center, prospective, parallel-group randomized controlled trial conducted at Elazig Fethi Sekin City Hospital.
Adult patients scheduled for elective surgery will be screened for eligibility and randomized in a 1:1 ratio to either:
Control Group:
Standard written informed consent and routine verbal anesthesia information.
- Intervention Group:
Standard written informed consent and routine verbal anesthesia information plus a standardized video-based educational intervention delivered through a QR code and viewed using a tablet device and headphones.
The educational video includes information regarding:
- Purpose of anesthesia
- Types of anesthesia
- Preoperative fasting requirements
- Preparation for surgery
- Perioperative process
- Potential complications
- Common temporary side effects
- Patient rights
- Meaning and importance of informed consent
Outcomes:
Primary Outcome:
Change in Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety score measured before and after completion of the information process.
Secondary Outcomes:
- Comprehensibility of information
- Patient satisfaction
Both secondary outcomes will be assessed using a structured 10-item Likert-type questionnaire.
Expected Impact:
This study will evaluate whether a standardized QR code-based video education model can improve patient understanding, reduce anxiety, and increase satisfaction. If effective, the intervention may provide a scalable and low-cost strategy for standardizing anesthesia information processes in routine clinical practice.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Sevim Şenol Karataş, MD
- Telefonnummer: +905325736611
- E-Mail: drsevimkaratas@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Sait F Öner, MD
- Telefonnummer: +90 533 627 13 58
- E-Mail: sfatihoner@gmail.com
Studienorte
-
-
Elâzığ
-
Elâzığ, Elâzığ, Türkei (türkiye), 23100
- Elazığ Fethi Sekin City Hospital
-
Hauptermittler:
- Sevim Şenol Karataş, MD
-
Kontakt:
- Sevim Şenol Karataş, MD
- Telefonnummer: +90 532 573 6611
- E-Mail: drsevimkaratas@gmail.com
-
Kontakt:
- Sait F Öner, MD
- Telefonnummer: +90 533 627 13 58
- E-Mail: sfatihoner@gmail.com
-
Unterermittler:
- Sait F Öner, MD
-
Unterermittler:
- Ferhat Karataş, PhD Student
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Control Group
Participants receive standard written informed consent and routine verbal anesthesia information according to routine clinical practice.
|
|
|
Experimental: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in APAIS Anxiety Score
Zeitfenster: Immediately before and immediately after completion of the information process (same study visit)
|
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).
|
Immediately before and immediately after completion of the information process (same study visit)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Information Comprehensibility Score
Zeitfenster: Immediately after completion of the information process
|
Comprehensibility of anesthesia information assessed using a structured 10-item Likert-type questionnaire.
|
Immediately after completion of the information process
|
|
Patient Satisfaction Score
Zeitfenster: Immediately after completion of the information process
|
Patient satisfaction with the anesthesia information process assessed using a structured 10-item Likert-type questionnaire.
|
Immediately after completion of the information process
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- QR Code-Based Video
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .