NCT07660705

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

June 16, 2026

Last Update Submit

July 18, 2026

Conditions

Keywords

Intensive Care UnitICU Family MembersQR CodeDigital EducationVideo-Based EducationAnxietyHealth CommunicationFamily-Centered CareRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Anxiety Score Measured by Visual Analog Scale for Anxiety (VAS-A)

    72 hours after enrollment

  • Information Satisfaction Score

    72 hours after enrollment

  • Resolution of Participant Information Needs

    72 hours after enrollment

Study Arms (2)

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.

Behavioral: QR Code-Based Digital Educational Video

Interventions

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.

QR Video Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersHealth Education

Condition Hierarchy (Ancestors)

Mental DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sevim Şenol Karataş, MD

    Elazıg Fethi Sekin Sehir Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

June 17, 2026

Primary Completion

July 17, 2026

Study Completion

July 17, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations