- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sevim Şenol Karataş, MD
- Phone Number: +905325736611
- Email: drsevimkaratas@gmail.com
Study Contact Backup
- Name: Sait F Öner, MD
- Phone Number: +90 533 627 13 58
- Email: sfatihoner@gmail.com
Study Locations
-
-
Elâzığ
-
Elâzığ, Elâzığ, Turkey (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
-
Principal Investigator:
- Sevim Şenol Karataş, MD
-
Contact:
- Sevim Şenol Karataş, MD
- Phone Number: +90 532 573 6611
- Email: drsevimkaratas@gmail.com
-
Contact:
- Sait F Öner, MD
- Phone Number: +90 533 627 13 58
- Email: sfatihoner@gmail.com
-
Sub-Investigator:
- Sait F Öner, MD
-
Sub-Investigator:
- Ferhat Karataş, PhD Student
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in APAIS Anxiety Score
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Information Comprehensibility Score
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QR Code-Based Video
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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