Educational Intervention for Patients Undergoing Cardiac Surgery

NCT07680192 | Completed

• 1 other identifier: CARDIO-EDU-2023
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Anxiety

  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 Outcomes (10)

• Postoperative Complications

  From surgery until 6 months post-surgery

• Pain Intensity

  Hospitalization through 6 months post-surgery

• Patient Satisfaction

  6 months post-surgery

• Length of ICU Stay

  From ICU admission after surgery until ICU discharge during the index hospitalization (up to 15 days after surgery).

• Length of Hospital Stay

  From hospital admission until hospital discharge (up to 30 days after surgery)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Nurse-Led Educational Intervention

Behavioral: Nurse-Led Educational Program

Control Group

NO INTERVENTION

Usual Care

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Farrús Torrella: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Health Education

Condition Hierarchy (Ancestors)

Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anna Farrús Torrella, RN, MSc, PhD Candidate

  Hospital Clínic de Barcelona/Universitat de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 2, 2026
• Study Start: January 20, 2024
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)