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

August 28, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
263

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Clínic 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anna Farrús Torrella

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Clinic of Barcelona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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