- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07660705
QR Code Video Education for ICU Family Members (QR-ICU)
Effect of a QR Code-Based Digital Information Video on Knowledge and Anxiety Among Family Members of Intensive Care Unit Patients: A Prospective Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Family members of patients admitted to intensive care units frequently experience anxiety, uncertainty, and a need for information regarding the patient's condition and ICU procedures. Conventional verbal information may vary depending on time constraints, workload, and communication practices, resulting in inconsistent delivery of information.
This prospective randomized controlled trial will investigate whether a standardized QR code-based digital information video can improve knowledge and reduce anxiety among family members of ICU patients. Eligible first-degree relatives of ICU patients will be randomized into two groups. The control group will receive routine verbal information according to standard clinical practice. The intervention group will receive routine verbal information in addition to access to a QR code-based educational video.
The educational video will provide information regarding the ICU environment, monitoring systems, mechanical ventilation, sedation practices, common procedures, visiting policies, and frequently encountered clinical situations. The video is designed to provide standardized, understandable, and easily accessible information.
The primary outcome will be the total score of the Information Adequacy and Comprehensibility Questionnaire. Secondary outcomes will include anxiety scores measured using the Visual Analog Scale for Anxiety (VAS-A), satisfaction with information, and participant-reported adequacy of answers to their information needs. Assessments will be performed at baseline, within 24 hours after the intervention, and 72 hours after enrollment.
A total of 150 participants will be enrolled. The study is conducted at Elazig Fethi Sekin City Hospital.
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
-
-
Merkez
-
Elâzığ, Merkez, Turkey (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
-
Contact:
- Sevim Şenol Karataş, MD
- Phone Number: +905325736611
- Email: drsevimkaratas@gmail.com
-
Principal Investigator:
- Sevim Şenol Karataş, MD
-
Contact:
- Sait F Öner, MD
- Phone Number: +90 533 627 13 58
- Email: sfatihoner@gmail.com
-
Sub-Investigator:
- Sait F Öner, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- First-degree family member of a patient admitted to the intensive care unit
- Able to read and understand Turkish
- Able to use a smartphone
- Able to access QR code-based educational materials
- Willing to participate and provide written informed consent
Exclusion Criteria:
- History of a diagnosed psychiatric disorder
- Current use of anxiolytic or antidepressant medication
- Visual or hearing impairment preventing participation in video-based education
- First-degree family member who is an active healthcare professional involved in patient care
- Inability to complete study questionnaires or follow-up assessments
- Refusal to participate in the study
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 routine verbal information regarding the intensive care unit and the patient's clinical condition according to standard clinical practice.
|
|
|
Experimental: QR Video Group
Participants receive routine verbal information in addition to access to a standardized QR code-based digital educational video about the intensive care unit, monitoring systems, mechanical ventilation, sedation, and common ICU procedures.
|
A standardized QR code-based educational video providing information about the intensive care unit environment, monitoring systems, mechanical ventilation, sedation practices, visiting policies, and frequently encountered clinical situations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Information Adequacy and Comprehensibility Questionnaire Total Score
Time Frame: 72 hours after enrollment
|
Total score of the Information Adequacy and Comprehensibility Questionnaire, a 15-item Likert-type questionnaire developed for this study.
Scores range from 15 to 75, with higher scores indicating better understanding and perceived adequacy of information.
|
72 hours after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Score Measured by Visual Analog Scale for Anxiety (VAS-A)
Time Frame: 72 hours after enrollment
|
Participant-reported anxiety measured using a 0-10 Visual Analog Scale for Anxiety (VAS-A), where higher scores indicate greater anxiety.
|
72 hours after enrollment
|
|
Information Satisfaction Score
Time Frame: 72 hours after enrollment
|
Participant satisfaction with information provided during the intensive care unit stay, measured using a 0-10 visual analog scale, with higher scores indicating greater satisfaction.
|
72 hours after enrollment
|
|
Resolution of Participant Information Needs
Time Frame: 72 hours after enrollment
|
Participants rate the extent to which their most important information needs and questions were answered using a 0-10 scale, with higher scores indicating better resolution of information needs.
|
72 hours after enrollment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sevim Şenol Karataş, MD, 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-Family
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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