Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)
Time Frame: 6 months after surgery
Secondary Outcomes
- 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).(From 10 days before surgery untill 1 day before surgery)
- 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.(From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery)
- Change in Physical Activity (International Physical Activity Questionnaire; IPAQ) from Baseline (an expected average of 10 days before surgery) to 6 months after surgery.(From 10 days before surgery to 6 months after surgery)
- Change in Health Related Quality of Life (SF-12) from Baseline (expected average of 10 days before surgery) to 6 months after surgery.(From 10 days before surgery to 6 months after surgery)
- 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.(From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery)
- 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.(From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.)
- 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.(From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.)
- Change in Working ability from Baseline (expected average of 10 days before surgery) to 6 months after surgery.(From 10 days before surgery to 6 months after surgery.)
- Satisfaction wiht the intervention.(Expected average of 1 day before surgery (but after the intervention).)
- Additional treatments during follow-up(6 months after surgery)
- Blinded Expert Rating of medical and psychological status at follow-up(6 months after surgery)
- Change in Sleep Quality from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.(From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.)
- 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.(From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.)
- Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file(6 months after surgery)
- Patients' experience with prior surgeries(Baseline (expected average of 10 days before surgery))
- Enriched Social Support Inventory(Baseline (expected average 10 days before surgery))
- Occurrence of major life events since surgery(6 months after surgery)
- 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.(From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery)
- Cardiothoracic surgeons' rating of the surgery success(Expected average of 1 day after surgery)
- Satisfaction with the intervention(6 months after surgery)
Investigators
Winfried Rief
Prof. Dr. Winfried Rief
Philipps University Marburg Medical Center