- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Selcuk
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Izmir, Selcuk, Tyrkiet (Türkiye), 35925
- Home
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: Control
Standard care group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Health-Related Quality of Life (EQ-5D-5L)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-14585038-21201-113088
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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