Educational Intervention for Patients Undergoing Cardiac Surgery (CARDIO-EDU)

June 26, 2026 updated by: Anna Farrús Torrella

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Usual Care
Experimental: Experimental Group
Nurse-Led Educational Intervention
Behavioral: Nurse-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline through 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From surgery until 6 months post-surgery
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.
Hospitalization through 6 months post-surgery
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.
6 months post-surgery
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.
From ICU admission after surgery until ICU discharge during the index hospitalization (up to 15 days after surgery).
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.
From hospital admission until hospital discharge (up to 30 days after surgery)
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.
Baseline, hospital admission, and 6 months post-surgery
Blood Pressure
Time Frame: Baseline, hospital admission, and 6 months post-surgery
Change in blood pressure measured before surgery and at follow-up.
Baseline, hospital admission, and 6 months post-surgery
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.
Baseline, hospital admission, and 6 months post-surgery
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.
Baseline, hospital admission, and 6 months post-surgery
Total Cholesterol
Time Frame: Baseline, hospital admission, and 6 months post-surgery
Change in total cholesterol levels measured before surgery and at follow-up.
Baseline, hospital admission, and 6 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Farrús Torrella

Collaborators

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Anna Farrús Torrella, RN, MSc, PhD Candidate, Hospital Clínic de Barcelona/Universitat de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2024

Primary Completion (Actual)

February 2, 2026

Study Completion (Actual)

February 2, 2026

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDIO-EDU-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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