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Completed

NCT Number: NCT07680192

Educational Intervention for Patients Undergoing Cardiac 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.

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Key information

Conditions

Cardiovascular Surgery Adherence Interventions Anxiety Anxiety Disorders Behavior Health Behavior Health Education Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Patient Education Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse-Led Educational Program

Behavioral

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.

Primary outcomes

  1. Anxiety

    Time frame: Baseline through 6 months after surgery

    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.

Secondary outcomes

  1. Postoperative Complications

    Time frame: From surgery until 6 months post-surgery

    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.

  2. Pain Intensity

    Time frame: Hospitalization through 6 months post-surgery

    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.

  3. Patient Satisfaction

    Time frame: 6 months post-surgery

    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.

  4. Length of ICU Stay

    Time frame: From 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.

  5. Length of Hospital Stay

    Time frame: From 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.

  6. Body Mass Index

    Time frame: Baseline, hospital admission, and 6 months post-surgery

    Change in body mass index measured before surgery and at follow-up.

  7. Blood Pressure

    Time frame: Baseline, hospital admission, and 6 months post-surgery

    Change in blood pressure measured before surgery and at follow-up.

  8. Fasting Blood Glucose

    Time frame: Baseline, hospital admission, and 6 months post-surgery

    Change in fasting blood glucose measured before surgery and at follow-up.

  9. Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, hospital admission, and 6 months post-surgery

    Change in glycated hemoglobin levels measured before surgery and at follow-up.

  10. Total Cholesterol

    Time frame: Baseline, hospital admission, and 6 months post-surgery

    Change in total cholesterol levels measured before surgery and at follow-up.

Sponsors and collaborators

Lead sponsor

Anna Farrús Torrella

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study title

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.

Acronym: CARDIO-EDU

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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