Educational Intervention for Patients Undergoing Cardiac Surgery (CARDIO-EDU)
Effectiveness of a Nursing Intervention for the Preparation and Follow-up of Patients Undergoing Cardiovascular Surgery. Design and Evaluation of a Nursing Educational Program for the Preparation and Follow-up of Patients Undergoing Cardiovascular Surgery.
Cardiovascular surgery is associated with high levels of anxiety, uncertainty, and postoperative complications. Educational interventions led by nurses may improve patients' psychological adaptation, self-care abilities, and recovery outcomes.
This randomized controlled trial aims to evaluate the effectiveness of a nurse-led educational program designed to prepare and support patients undergoing cardiovascular surgery. Participants are randomly assigned to either an intervention group receiving a structured perioperative educational program or a control group receiving usual care.
The primary outcome is anxiety. Secondary outcomes include posoperative complications, patient satisfaction, pain intensity, length of ICU Stay, length of Hospital Stay, Body Mass Index, blood pressure, fasting blood glucose, Glycated Hemoglobin (HbA1c) and total Cholesterol. Participants are followed for six months after surgery.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Patients undergoing cardiovascular surgery frequently experience anxiety and uncertainty before surgery and during postoperative recovery. Adequate preparation and follow-up may improve psychological well-being, promote self-care, and facilitate recovery.
This single-center randomized controlled trial evaluates a nurse-led educational intervention for patients undergoing elective cardiovascular surgery at Hospital Clínic de Barcelona. The intervention includes structured education and follow-up throughout the perioperative period, focusing on preparation for surgery, postoperative recovery, self-care, symptom management, and lifestyle recommendations.
Participants are randomly allocated to either the intervention group or the usual care group. Outcomes are assessed at baseline, during hospitalization, and during follow-up up to six months after surgery.
The primary outcome is anxiety measured using validated assessment instruments. Secondary outcomes include self-efficacy, self-care capacity, health-related quality of life, postoperative complications, hospital readmissions, healthcare utilization, and patient satisfaction.
The study aims to determine whether a structured nurse-led educational program improves psychological, behavioral, and clinical outcomes in patients undergoing cardiovascular surgery.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Barcelona
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Barcelona, Barcelona, Spanje, 08036
- Hospital Clínic de Barcelona
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients undergoing first-time cardiac surgery.
- Ability to understand and communicate in Spanish or Catalan.
- Provision of written informed consent.
Exclusion Criteria:
- Refusal or inability to provide informed consent.
- Previous cardiovascular surgery.
- Transcatheter aortic valve implantation (TAVI) or other percutaneous procedures.
- Cardiogenic shock before surgery requiring sedation and endotracheal intubation.
- Psychiatric disorders requiring treatment, including anxiety disorders, depression, alcoholism, dementia, psychosis, schizophrenia, amnesia, or personality disorders.
- Severe chronic diseases, including cirrhosis, hepatitis B or C, HIV/AIDS, Parkinson's disease, severe autoimmune disorders, blindness, or severe hearing impairment.
- Intensive care unit stay longer than 15 days after surgery.
- Death during hospitalization, including perioperative mortality.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Controlegroep
Gebruikelijke zorg
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Experimenteel: Experimental Group
Nurse-Led Educational Intervention
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A structured nurse-led educational program delivered throughout the perioperative period for patients undergoing cardiovascular surgery.
The intervention included preoperative education, preparation for surgery, postoperative recovery guidance, self-care education, symptom management, lifestyle recommendations, and follow-up support after hospital discharge.
The program aimed to reduce anxiety and improve self-efficacy, self-care, and recovery outcomes.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Anxiety
Tijdsspanne: Baseline through 6 months after surgery
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Anxiety assessed using the Hospital Anxiety and Depression Scale (HADS).
Total HADS scores range from 0 to 42, with higher scores indicating greater emotional distress.
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Baseline through 6 months after surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative Complications
Tijdsspanne: From surgery until 6 months post-surgery
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Number and type of postoperative complications during hospitalization and within 6 months after cardiovascular surgery, including atrial fibrillation, hypotension, hypertension, acute kidney injury, acute respiratory distress syndrome, surgical wound infection, delirium, and hospital readmission.
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From surgery until 6 months post-surgery
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Pain Intensity
Tijdsspanne: Hospitalization through 6 months post-surgery
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Pain assessed using the Numeric Rating Scale (NRS/EVN) during hospitalization and follow-up.
Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
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Hospitalization through 6 months post-surgery
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Patient Satisfaction
Tijdsspanne: 6 months post-surgery
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Patient satisfaction with perioperative education, preparation, support, and follow-up measured using a study-specific questionnaire.
Scores range from 0 to 40, with higher scores indicating greater satisfaction.
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6 months post-surgery
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Length of ICU Stay
Tijdsspanne: From ICU admission after surgery until ICU discharge during the index hospitalization (up to 15 days after surgery).
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Number of days spent in the intensive care unit after cardiovascular surgery.
From ICU admission after surgery until ICU discharge, during the index hospitalization.
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From ICU admission after surgery until ICU discharge during the index hospitalization (up to 15 days after surgery).
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Length of Hospital Stay
Tijdsspanne: From hospital admission until hospital discharge (up to 30 days after surgery)
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Total number of days hospitalized following cardiovascular surgery.
From hospital admission (previous day of surgery) until hospital discharge.
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From hospital admission until hospital discharge (up to 30 days after surgery)
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Body Mass Index
Tijdsspanne: Baseline, hospital admission, and 6 months post-surgery
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Change in body mass index measured before surgery and at follow-up.
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Baseline, hospital admission, and 6 months post-surgery
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Blood Pressure
Tijdsspanne: Baseline, hospital admission, and 6 months post-surgery
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Change in blood pressure measured before surgery and at follow-up.
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Baseline, hospital admission, and 6 months post-surgery
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Fasting Blood Glucose
Tijdsspanne: Baseline, hospital admission, and 6 months post-surgery
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Change in fasting blood glucose measured before surgery and at follow-up.
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Baseline, hospital admission, and 6 months post-surgery
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Glycated Hemoglobin (HbA1c)
Tijdsspanne: Baseline, hospital admission, and 6 months post-surgery
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Change in glycated hemoglobin levels measured before surgery and at follow-up.
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Baseline, hospital admission, and 6 months post-surgery
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Total Cholesterol
Tijdsspanne: Baseline, hospital admission, and 6 months post-surgery
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Change in total cholesterol levels measured before surgery and at follow-up.
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Baseline, hospital admission, and 6 months post-surgery
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anna Farrús Torrella, RN, MSc, PhD Candidate, Hospital Clínic de Barcelona/Universitat de Barcelona
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CARDIO-EDU-2023
Plan Individuele Deelnemersgegevens (IPD)
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