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This prospective randomized controlled study aims to evaluate the effect of a QR code-based digital information video on knowledge level and anxiety among family members of intensive care unit (ICU) patients. Participants will be randomly assigned to either a control group receiving routine verbal information or an intervention group receiving routine verbal information plus access to a standardized QR code-based educational video. Knowledge level, anxiety, and satisfaction with information will be assessed at baseline, within 24 hours after the intervention, and 72 hours later. The study will determine whether digital video-based information improves understanding of the ICU environment and reduces anxiety among family members.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants receive routine verbal information regarding the intensive care unit and the patient's clinical condition according to standard clinical practice. | |
| QR Video Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QR Code-Based Digital Educational Video | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Information Adequacy and Comprehensibility Questionnaire Total Score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Score Measured by Visual Analog Scale for Anxiety (VAS-A) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sevim Şenol Karataş, MD | Contact | +905325736611 | drsevimkaratas@gmail.com | |
| Sait F Öner, MD | Contact | +90 533 627 13 58 | sfatihoner@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sevim Şenol Karataş, MD | Elazıg Fethi Sekin Sehir Hastanesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elazığ Fethi Sekin City Hospital | Elâzığ | Merkez | 23100 | Turkey (Türkiye) |
Individual participant data will not be made publicly available because the study includes potentially identifiable participant information and no data-sharing plan has been established.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
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Participants will be randomly assigned in a 1:1 ratio to either a control group receiving routine verbal information or an intervention group receiving routine verbal information plus a QR code-based digital educational video. Outcomes will be assessed at baseline, within 24 hours after the intervention, and 72 hours after enrollment.
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Due to the nature of the intervention, participants and investigators are aware of group assignment. Family members in the intervention group receive access to a QR code-based educational video in addition to routine verbal information, whereas participants in the control group receive routine verbal information only. Therefore, blinding is not feasible.
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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 | 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 |
| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |