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Completed

NCT Number: NCT01407055

Optimizing Expectations in Cardiac Surgery Patients

The purpose of this study is to evaluate the potential benefit of targeting patients' expectations before coronary artery bypass graft surgery through a brief psychoeducational intervention.

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Key information

Conditions

Coronary Artery Bypass Graft Surgery (CABG) Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Patients' Expectations Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Philipps University of Marburg

Marburg, Hesse, 35032, Germany

About this study

Coronary artery bypass graft surgery (CABG) is an extremely invasive medical intervention.It is postulated that even under these conditions, treatment outcome is substantially determined by non-specific effects, e.g. patient's expectation. Targeting patients' expectations at an early stage might have potential to optimize outcomes after cardiac surgery. The purpose of this research project is to optimize patients' outcome expectations before undergoing cardiac surgery through a brief psycho-educational program. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned either to standard medical information alone, or to an additional expectation manipulation intervention (EMI) during the two weeks before surgery, or to an attention-control group ("supportive therapy"). The main goal is to enhance positive expectations (surgery 'non-specific effects') about favorable outcome through EMI, about coping abilities to deal with adverse events, and to reduce negative expectations and misconceptions. Assessment takes place before and after EMI, 10 days after surgery and 6 months later; same assessment points are used for the 2 control conditions. Primary outcome is disability, which has been shown to be strongly determined by patient's expectation in previous studies. Moreover, psychological and biological predictors and mediators of treatment success are analyzed. A positive result for this expectation intervention would have major implications for clinical practice. In order to optimize treatment outcome, it is not only necessary to improve the treatment-specific procedures (e.g., cardiac surgery) but also to address non-specific factors such as patients' expectations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled on the elective waiting list for first time coronary artery bypass graft surgery wiht the use of heart-lung-apparatus at the Department of Cardiovascular Surgery, Medical School, University of Marburg
  • Sufficient knowledge of German language
  • Ability to give informed consent

Exclusion criteria

  • Emergency surgery
  • Presence of a serious comorbid psychiatric condition
  • Presence of a life threatening comorbid medical condition
  • Current participation in other research

Treatment and study plan

Expectation Manipulation Intervention

Behavioral

The Expectation Manipulation Intervention targets patients' expectations prior to surgery (2 individual sessions, 2 phone calls). Main goal is to enhance positive outcome expectancies, as well as to improve patients' control expectations about possible side effects of the surgery and about their personal management of their coronary heart disease. Further EMI tries to correct dysfunctional beliefs about the coronary heart disease and tries to minimize fears about expected negative consequences.

Supportive Therapy

Behavioral

Supportive therapy employs common factors such as elicitation of affect, reflective listening, feeling understood, but provides no explicit theoretical formulation to the patient. Supportive therapy thus provides a control condition for common factors and therapist attention but lacks the specific intervention part. It will be delivered in the same frequency and at the same time points as the Expectation Manipulation Intervention (2 individual sessions, 2 phone calls).

Primary outcomes

  1. Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)

    Time frame: 6 months after surgery

Secondary outcomes

  1. Change in Patients' Expectations from Baseline/Pre-Intervention (expected average of 10 days before surgery) to hospital admission/Post-Intervention (expected average of 1 day before surgery).

    Time frame: From 10 days before surgery untill 1 day before surgery

    Prospective Illness Perception 6 months after surgery (Expected Illness Perception Questionnaire; IPQ-E), Positive Health Expectation Scale (PHES), Expected Disability (PDI-E)

  2. Change in Cardiac Anxiety (Cardiac Anxiety Questionnaire; CAQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    Time frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery

  3. Change in Physical Activity (International Physical Activity Questionnaire; IPAQ) from Baseline (an expected average of 10 days before surgery) to 6 months after surgery.

    Time frame: From 10 days before surgery to 6 months after surgery

  4. Change in Health Related Quality of Life (SF-12) from Baseline (expected average of 10 days before surgery) to 6 months after surgery.

    Time frame: From 10 days before surgery to 6 months after surgery

  5. Change in physical symptoms, subjective side effects and post-surgery complaints (Generic Assessment of Side Effects Scale; GASE-P)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    Time frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery

  6. Change in Hospital Anxiety and Depression Scale (HADS)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    Time frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

  7. Change in Beliefs about Medications (Beliefs about Medications Questionaire; BMQ)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    Time frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

  8. Change in Working ability from Baseline (expected average of 10 days before surgery) to 6 months after surgery.

    Time frame: From 10 days before surgery to 6 months after surgery.

  9. Satisfaction wiht the intervention.

    Time frame: Expected average of 1 day before surgery (but after the intervention).

  10. Cardiothoracic surgeons' rating of the surgery success

    Time frame: Expected average of 1 day after surgery

  11. Additional treatments during follow-up

    Time frame: 6 months after surgery

    Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc.

  12. Blinded Expert Rating of medical and psychological status at follow-up

    Time frame: 6 months after surgery

  13. Change in Sleep Quality from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    Time frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

  14. Change in neuroendocrine and immunological measures from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    Time frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    cortisol, inflammatory processes, catecholamines

  15. Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file

    Time frame: 6 months after surgery

    From Patient file:

    Left ventricular ejection fraction (EF), Body Mass Index, Blood pressure, Smoking status, Cardiac Operative Risk (EuroSCORE), New York Heart Association classification (NYHA), Canadian Cardiovascular Society grading of angina pectoris (CCS), Number of diseased coronary vessels, Previous myocardial infarctions, extra-cardiac arteriopathy, non-cardiac comorbidities, surgery procedure, surgery complications and in-hospital post surgery complications, time spent on the intensive care unit, inpatient days until discharge

  16. Patients' experience with prior surgeries

    Time frame: Baseline (expected average of 10 days before surgery)

    Rating of experience with own prior surgeries. Rating of experience with surgeries of close others.

  17. Enriched Social Support Inventory

    Time frame: Baseline (expected average 10 days before surgery)

  18. Occurrence of major life events since surgery

    Time frame: 6 months after surgery

  19. Change in Patients' Illness Perception (Brief Illness Perception Questionnaire (B-IPQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.

    Time frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery

  20. Satisfaction with the intervention

    Time frame: 6 months after surgery

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 1, 2011
Registry last updated
Feb 3, 2016

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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