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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sevim Şenol Karataş, MD
- Numero di telefono: +905325736611
- Email: drsevimkaratas@gmail.com
Backup dei contatti dello studio
- Nome: Sait F Öner, MD
- Numero di telefono: +90 533 627 13 58
- Email: sfatihoner@gmail.com
Luoghi di studio
-
-
Elâzığ
-
Elâzığ, Elâzığ, Turchia (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
-
Investigatore principale:
- Sevim Şenol Karataş, MD
-
Contatto:
- Sevim Şenol Karataş, MD
- Numero di telefono: +90 532 573 6611
- Email: drsevimkaratas@gmail.com
-
Contatto:
- Sait F Öner, MD
- Numero di telefono: +90 533 627 13 58
- Email: sfatihoner@gmail.com
-
Sub-investigatore:
- Sait F Öner, MD
-
Sub-investigatore:
- Ferhat Karataş, PhD Student
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Control Group
Participants receive standard written informed consent and routine verbal anesthesia information according to routine clinical practice.
|
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in APAIS Anxiety Score
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Information Comprehensibility Score
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- QR Code-Based Video
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .