- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sevim Şenol Karataş, MD
- 전화번호: +905325736611
- 이메일: drsevimkaratas@gmail.com
연구 연락처 백업
- 이름: Sait F Öner, MD
- 전화번호: +90 533 627 13 58
- 이메일: sfatihoner@gmail.com
연구 장소
-
-
Merkez
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Elâzığ, Merkez, 터키 (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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연락하다:
- Sevim Şenol Karataş, MD
- 전화번호: +905325736611
- 이메일: drsevimkaratas@gmail.com
-
수석 연구원:
- Sevim Şenol Karataş, MD
-
연락하다:
- Sait F Öner, MD
- 전화번호: +90 533 627 13 58
- 이메일: sfatihoner@gmail.com
-
부수사관:
- Sait F Öner, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control Group
Participants receive routine verbal information regarding the intensive care unit and the patient's clinical condition according to standard clinical practice.
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|
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Information Adequacy and Comprehensibility Questionnaire Total Score
기간: 72 hours after enrollment
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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.
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72 hours after enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anxiety Score Measured by Visual Analog Scale for Anxiety (VAS-A)
기간: 72 hours after enrollment
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Participant-reported anxiety measured using a 0-10 Visual Analog Scale for Anxiety (VAS-A), where higher scores indicate greater anxiety.
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72 hours after enrollment
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Information Satisfaction Score
기간: 72 hours after enrollment
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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.
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72 hours after enrollment
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Resolution of Participant Information Needs
기간: 72 hours after enrollment
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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.
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72 hours after enrollment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sevim Şenol Karataş, MD, Elazıg Fethi Sekin Sehir Hastanesi
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- QR Code-Family
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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