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Educational Intervention for Patients Undergoing Cardiac Surgery

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07680192
Acronym
CARDIO-EDU
Enrollment
263
Registered
2026-07-02
Start date
2024-01-20
Completion date
2026-02-02
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cardiovascular Surgery, Patient Education

Keywords

Nurse-Led Intervention, Cardiovascular Surgery, Patient Education, Anxiety, Cardiac Surgery, Perioperative Care, Self-Care, Health Education, HADS, Postoperative Recovery

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALNurse-Led Educational Program

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.

Sponsors

Anna Farrús Torrella
Lead SponsorOTHER
Hospital Clinic of Barcelona
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Participants were randomly assigned to either a nurse-led educational intervention group or a usual care control group and followed for six months after cardiovascular surgery.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
AnxietyBaseline through 6 months after surgeryAnxiety assessed using the Hospital Anxiety and Depression Scale (HADS). Total HADS scores range from 0 to 42, with higher scores indicating greater emotional distress.

Secondary

MeasureTime frameDescription
Patient Satisfaction6 months post-surgeryPatient 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.
Length of ICU StayFrom ICU admission after surgery until ICU discharge during the index hospitalization (up to 15 days after surgery).Number of days spent in the intensive care unit after cardiovascular surgery. From ICU admission after surgery until ICU discharge, during the index hospitalization.
Length of Hospital StayFrom hospital admission until hospital discharge (up to 30 days after surgery)Total number of days hospitalized following cardiovascular surgery. From hospital admission (previous day of surgery) until hospital discharge.
Body Mass IndexBaseline, hospital admission, and 6 months post-surgeryChange in body mass index measured before surgery and at follow-up.
Blood PressureBaseline, hospital admission, and 6 months post-surgeryChange in blood pressure measured before surgery and at follow-up.
Fasting Blood GlucoseBaseline, hospital admission, and 6 months post-surgeryChange in fasting blood glucose measured before surgery and at follow-up.
Glycated Hemoglobin (HbA1c)Baseline, hospital admission, and 6 months post-surgeryChange in glycated hemoglobin levels measured before surgery and at follow-up.
Total CholesterolBaseline, hospital admission, and 6 months post-surgeryChange in total cholesterol levels measured before surgery and at follow-up.
Pain IntensityHospitalization through 6 months post-surgeryPain 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.
Postoperative ComplicationsFrom surgery until 6 months post-surgeryNumber 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.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORAnna Farrús Torrella, RN, MSc, PhD Candidate

Hospital Clínic de Barcelona/Universitat de Barcelona

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026