Cardiovascular SurgeryCARDIO-EDUNCT07680192
Educational Intervention for Patients Undergoing Cardiac Surgery
A study testing Nurse-Led Educational Program in people with Cardiovascular Surgery and Anxiety, run by Anna Farrús Torrella at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Surgery, Anxiety, Patient Education
- What is being tested?
- Nurse-Led Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2024to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Cardiovascular Surgery, Anxiety, Patient Education
- Being tested
- Nurse-Led Educational Program
- Keywords
- Nurse-Led Intervention, Cardiovascular Surgery, Patient Education, Anxiety, Cardiac Surgery, Perioperative Care, Self-Care, Health Education, HADS, Postoperative Recovery
- Medical subject headings
- Anxiety Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Educational ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Nurse-Led Educational Intervention Receives: Behavioral: Nurse-Led Educational Program |
| Control Group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 6 months after surgery
Secondary outcomes (10)
Postoperative Complications
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.
Measured: From surgery until 6 months post-surgery
Pain Intensity
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.
Measured: Hospitalization through 6 months post-surgery
Patient Satisfaction
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.
Measured: 6 months post-surgery
Length of ICU Stay
Number of days spent in the intensive care unit after cardiovascular surgery. From ICU admission after surgery until ICU discharge, during the index hospitalization.
Measured: From ICU admission after surgery until ICU discharge during the index hospitalization (up to 15 days after surgery).
Length of Hospital Stay
Total number of days hospitalized following cardiovascular surgery. From hospital admission (previous day of surgery) until hospital discharge.
Measured: From hospital admission until hospital discharge (up to 30 days after surgery)
Body Mass Index
Change in body mass index measured before surgery and at follow-up.
Measured: Baseline, hospital admission, and 6 months post-surgery
Blood Pressure
Change in blood pressure measured before surgery and at follow-up.
Measured: Baseline, hospital admission, and 6 months post-surgery
Fasting Blood Glucose
Change in fasting blood glucose measured before surgery and at follow-up.
Measured: Baseline, hospital admission, and 6 months post-surgery
Glycated Hemoglobin (HbA1c)
Change in glycated hemoglobin levels measured before surgery and at follow-up.
Measured: Baseline, hospital admission, and 6 months post-surgery
Total Cholesterol
Change in total cholesterol levels measured before surgery and at follow-up.
Measured: Baseline, hospital admission, and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start20 Jan 2024
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Farrús Torrella
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor-investigator, Anna Farrús Torrella, University of Barcelona
- Investigators
- Anna Farrús Torrella, RN, MSc, PhD Candidate, Principal investigator, Hospital Clínic de Barcelona/Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680192
- Sponsor's protocol ID
- CARDIO-EDU-2023
- Acronym
- CARDIO-EDU
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07680192
- Acronym / sponsor ID
- CARDIO-EDU / CARDIO-EDU-2023
- Conditions
- Cardiovascular Surgery, Anxiety, Patient Education
- Keywords
- Nurse-Led Intervention, Cardiovascular Surgery, Patient Education, Anxiety, Cardiac Surgery, Perioperative Care, Self-Care, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Anna Farrús TorrellaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Nurse-Led Educational ProgramNurse-Led Educational Intervention |
| Control Group | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Educational ProgramA 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. | Behavioural | Experimental Group |
Primary outcome
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.
10 secondary outcomes
Postoperative Complications
Time frame: From surgery until 6 months post-surgery
Pain Intensity
Time frame: Hospitalization through 6 months post-surgery
Patient Satisfaction
Time frame: 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).
Length of Hospital Stay
Time frame: 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
Blood Pressure
Time frame: Baseline, hospital admission, and 6 months post-surgery
Fasting Blood Glucose
Time frame: Baseline, hospital admission, and 6 months post-surgery
Glycated Hemoglobin (HbA1c)
Time frame: Baseline, hospital admission, and 6 months post-surgery
Total Cholesterol
Time frame: Baseline, hospital admission, and 6 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Surgery
Not yet recruitingObservational study
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Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
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SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
Atrial Fibrillation, Postoperative Atrial Fibrillation
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
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Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Farrús Torrella, RN, MSc, PhD Candidate principal investigator
Hospital Clínic de Barcelona/Universitat de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Educational Program in people with Cardiovascular Surgery and Anxiety, run by Anna Farrús Torrella at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline through 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.