- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07588321
E-Health-Supported Preoperative Education
EVALUATION OF THE EFFECTIVENESS OF PRE-OPERATIVE EDUCATION PROVIDED TO PATIENTS UNDERGOING CHEST SURGERY VIA AN E-HEALTH APPLICATION: A RANDOMIZED CONTROLLED STUDY
In the context of patient education, the integration of mobile applications-an e-health modality-among healthcare professionals and patients has garnered significant attention alongside technological advancements. Mobile applications offer distinct advantages, notably the vast global population capable of accessing and utilizing these digital tools. A study evaluating the impact of mobile applications on the recovery of patients undergoing ambulatory surgery demonstrated that the quality of recovery was superior in the intervention group. In research investigating mobile application-based education following breast cancer surgery, significant improvements were observed in pain levels, affected shoulder functions, and anxiety levels within the intervention group .
Among patients undergoing cardiac surgery, 98% of those who received education via a mobile application reported that the application was beneficial to their recovery process . Furthermore, in a study involving a mobile application for patients undergoing heart valve surgery, the intervention group exhibited significantly lower probabilities of hospitalization, emergency department visits, and complications . An integrative review of mobile applications in the health education of surgical patients noted that while research has involved bariatric, orthopedic, colorectal, mastectomy, urological, and neurological surgical patients, there is an emphasized need for further nursing research utilizing emerging communication technologies.
To date, no studies evaluating the effectiveness of preoperative education delivered via mobile application for patients undergoing thoracic surgery have been identified. Initiating preoperative preparation for patients scheduled for thoracic surgery is anticipated to positively influence postoperative recovery and quality of life, highlighting the necessity for research in this domain.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Selcuk
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Izmir, Selcuk, 터키 (Türkiye), 35925
- Home
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18 years and older
- Patients with full spatial and temporal orientation
- Patients without significant hearing or vision impairments
- Patients with the ability to read and write
- Patients scheduled for elective thoracic surgery due to a lung mass
- Patients who voluntarily agree to participate and provide written informed consent
- Patients who own and can operate a smartphone
Exclusion Criteria:
- Patients scheduled for emergency thoracic surgery
- Patients with physical limitations that prevent mobilization or participation in study tests
- Patients with cognitive impairments (as they may fail to provide accurate data via the app)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: E-health preoperative education
E-health education group
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Preoperative education provided to patients via a mobile e-health application including video-based and written educational content developed based on current thoracic surgery guidelines.
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간섭 없음: Control
Standard care group
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Health-Related Quality of Life (EQ-5D-5L)
기간: 10 days before surgery and 10 days after surgery.
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Health-related quality of life will be assessed using the Turkish version of the EQ-5D-5L scale.
The scale consists of two parts: a descriptive system covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the EQ Visual Analogue Scale (EQ VAS).
The descriptive system provides a health state profile across five levels for each dimension.
The EQ VAS is a vertical 0-100 scale where 0 represents "the worst health you can imagine" and 100 represents "the best health you can imagine."
Assessments will be conducted 10 days before surgery and 10 days after surgery.
The study will utilize the official Turkish translation provided by the EuroQol Research Foundation.
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10 days before surgery and 10 days after surgery.
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Postoperative Physical Capacity (6-Minute Walk Test)
기간: Day 3 post-operatively
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Postoperative physical capacity will be evaluated using the 6-Minute Walk Test (6MWT).
This test measures the maximum distance (in meters) a patient can walk at a self-selected pace on a flat surface in 6 minutes.
The mobilization levels and total walking time (in minutes) will also be recorded to compare the physical recovery and functional capacity between the intervention group (mobile app-based training) and the control group (standard training).
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Day 3 post-operatively
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Postoperative Pulmonary Complications
기간: Day 3 post-operatively
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Evaluation of respiratory complications based on clinical signs and laboratory findings.
A complication is defined as meeting two or more criteria, including respiratory distress, abnormal breath sounds, and abnormal white blood cell counts (leukopenia or leukocytosis) according to standard clinical reference ranges.
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Day 3 post-operatively
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State Anxiety Inventory (STAI-I)
기간: 10 days before surgery and Day 3 post-operatively
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The State Anxiety Inventory (STAI-I) is a 20-item self-report scale that measures current anxiety.
Scores range from 20 to 80, with higher scores indicating higher anxiety levels.
It uses a 4-point Likert-type scale for each item.
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10 days before surgery and Day 3 post-operatively
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Length of Hospital Stay
기간: From the date of surgery until the date of hospital discharge
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The length of hospital stay (measured in days) will be recorded and compared between the intervention and control groups.
The duration will be calculated from the day of surgery until the day of discharge.
Data will be obtained from the patients' medical records after discharge to evaluate whether mobile application-based training has an impact on the timing of clinical recovery and hospital resource utilization.
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From the date of surgery until the date of hospital discharge
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Wang B, Qi F, Wang Y, Zhang J, Li W, Li X. Effectiveness of refined nursing intervention on postoperative recovery and respiratory function in lung cancer patients after thoracic surgery. Medicine (Baltimore). 2024 Nov 1;103(44):e40209. doi: 10.1097/MD.0000000000040209.
- Ben-Ali, W., & Lamarche, Y. (2021). Aortic Insufficiency in Patients With Left Ventricular Assist Device. Canadian Journal of Cardiology, 37(8), 1253-1262.
- Dawson, R. M., & Felder, T. M. (2020). Exploring the recruitment of African American women in biobehavioral breast cancer research. Journal of Nursing Scholarship, 52(4), 345-354.
- Machado, R. C. G., et al. (2020). Factors associated with patient safety climate in a specialized cardiovascular hospital. Revista Latino-Americana de Enfermagem, 28, e3323.
- Venkatraman, V., & Lad, S. P. (2023). Digital Health and Neurosurgery. Neurosurgery Clinics of North America, 34(4), 519-528.
- Aydin A, Gursoy A. Nurse-led support impact via a mobile app for breast cancer patients after surgery: a quasi-experimental study (step 2). Support Care Cancer. 2024 Aug 20;32(9):598. doi: 10.1007/s00520-024-08819-2.
- Li C, Shao H, Huang S, Zhang T, Su X, Zhu S. Effects of an Individualized Fasting Program on Fasting Time and Comfort in Infants and Young Children During the Perioperative Period. J Perianesth Nurs. 2020 Jun;35(3):326-330. doi: 10.1016/j.jopan.2019.08.014. Epub 2020 Jan 20.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- E-14585038-21201-113088
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Sinai UniversityMenoufia University완전한
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National Taiwan University Hospital초대로 등록소아과 | 폐외과 | 수술 후 빠른 회복(Enhanced Recovery After Surgery, ERAS)대만
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Assistance Publique Hopitaux De Marseille완전한심혈관 질환 | 비만 환자 | Bariatric Surgery 전후의 이러한 TRL의 생성률프랑스
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Dong Yang알려지지 않은복강경 보조 수술 | 절개 없는 복강경 전수술(Natural Orifice Transluminal Endoscopic Surgery, NOSES)중국
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University Hospital, Strasbourg, France모병Cervico-Facial Surgery ENT 프랑스의 학술 의료 및 외과 교육 | Cervico-Facial Surgery ENT Medical 레지던트(Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine 및 Provence-Alpes-Côte d'Azur 지역)프랑스
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King Abdulaziz University모병측두하악 장애(TMD) | TMJ 통증 | 미술치료 | TMJ- Oral & amp; Maxillofacial Surgery | 윌크스 1과 2 | TMD 예술 통증 연구사우디 아라비아
E-health education에 대한 임상 시험
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Chia-Tzu Line완전한
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Second Affiliated Hospital, School of Medicine,...완전한
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Centre Hospitalier Universitaire Dijon종료됨
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The Hong Kong Polytechnic UniversityTung Wah College; Hospital Authority, Hong Kong모병
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Institut Català d'OncologiaInstitut d'Investigació Biomèdica de Bellvitge; Asociación Española contra el Cáncer모병
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Tung Wah CollegeThe Hong Kong Polytechnic University; University of Southampton아직 모집하지 않음인지적 허약함