QR Code Video Education for ICU Family Members (QR-ICU)

July 18, 2026 updated by: Elazıg Fethi Sekin Sehir Hastanesi

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Elâzığ, Merkez, Turkey (Türkiye), 23100
        • Elazığ Fethi Sekin City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: QR Code-Based Digital Educational Video
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elazıg Fethi Sekin Sehir Hastanesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sevim Şenol Karataş, MD, Elazıg Fethi Sekin Sehir Hastanesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QR Code-Family

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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