AnxietyQR-ICUNCT07660705
QR Code Video Education for ICU Family Members
A study testing QR Code-Based Digital Educational Video in people with Anxiety and Health Education, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Health Education, Family Members of Intensive Care Unit Patients
- What is being tested?
- QR Code-Based Digital Educational Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2026to 17 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23100
About this study
Official title: 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
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.
Read the 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.
- Being tested
- QR Code-Based Digital Educational Video
- Keywords
- Intensive Care Unit, ICU Family Members, QR Code, Digital Education, Video-Based Education, Anxiety, Health Communication, Family-Centered Care, Randomized Controlled Trial
- Medical subject headings
- Anxiety Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QR Code-Based Digital Educational VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: QR Code-Based Digital Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after enrollment
Secondary outcomes (3)
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.
Measured: 72 hours after enrollment
Information Satisfaction Score
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.
Measured: 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.
Measured: 72 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start17 Jun 2026
- Primary completion17 Jul 2026
- Study completion17 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevim Şenol Karataş, MD, Principal investigator, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660705
- Sponsor's protocol ID
- QR Code-Family
- Acronym
- QR-ICU
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07660705
- Acronym / sponsor ID
- QR-ICU / QR Code-Family
- Keywords
- Intensive Care Unit, ICU Family Members, QR Code, Digital Education, Video-Based Education, Anxiety, Health Communication, Family-Centered Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: QR Code-Based Digital Educational VideoParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QR Code-Based Digital Educational VideoA 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. | Behavioural | QR Video Group |
Primary outcome
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.
3 secondary outcomes
Anxiety Score Measured by Visual Analog Scale for Anxiety (VAS-A)
Time frame: 72 hours after enrollment
Information Satisfaction Score
Time frame: 72 hours after enrollment
Resolution of Participant Information Needs
Time frame: 72 hours after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Anxiety
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim Şenol Karataş, MD principal investigator
Elazıg Fethi Sekin Sehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QR Code-Based Digital Educational Video in people with Anxiety and Health Education, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information Adequacy and Comprehensibility Questionnaire Total Score (time frame: 72 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.