Preoperative Optimization of Cardiac Valve Patients' Expectations
- Conditions
- Cardiac Valve Disease
- Registration Number
- NCT04502121
- Lead Sponsor
- Philipps University Marburg Medical Center
- Brief Summary
Recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients. However, what content works best for which patient group and how long an intervention has to be is still largely unknown. The aims of this study are thus to examine if the developed preoperative psychological intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative recovery. Therefore, a brief intervention has been developed. Heart valve patients who undergo a heart surgery will be randomized into two groups (Control vs. intervention group) after baseline assessment. Following this the intervention group will participate in the psychological intervention (30-40 minutes). To increase patients' positive expectations the intervention will focus on treatment outcome expectations and personal control expectations. Furthermore, patients in the intervention group will have two booster-telephone calls (four and eight weeks after the surgery) to check if their developed plans work out. The control group will receive the standard medical procedure. Both groups will fill out questionnaires again at the evening before the surgery, around one week after the surgery and three months after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- Patients who are scheduled for elective cardiac valve procedure
- Age 18 or above
- Fluency in German
- Informed consent
- Comorbid medical/psychiatric condition that causes more extensive disability than the coronary condition
- Participation in other research programs: in agreement with Coordinating Investigator patient can participate substudies, if this do not interfere with the main study
- Emergency surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery Baseline, up to one week post-surgery, up to three months post-surgery Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.
Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery Baseline, up to one week post-surgery, up to three months post-surgery There are different item scales. The item scale of the first item (General health perceptions) ranges from 1 (excellent) to 5 (bad). The item scales of the second and third item (limitations in physical activities because of health problems) range from 1 (yes, absolutely restricted) to 2 (yes, a bit restricted) to 3 (no, not restricted at all). The item scales of the items 4-7 (limitations in usual role activities because of physical health or emotional problems) are just "yes" and "no". The item scale of the eighth item (bodily pain) ranges from 1 (Absolutely not) to 5 (a lot). The item scales of the items 9-12 (general mental health, vitality and limitations in social activities because of physical or emotional problems) range from 1 (always) to 5 (never).
Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery Baseline, up to one week post-surgery, up to three months post-surgery Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome.
Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery Baseline, one day pre-surgery Items range from 1 (not at all) - 5 (extremely). Higher scores mean patients are more interested in information and do have greater worries.
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery Baseline, up to one week post-surgery, up to three months post-surgery Items range from 0 (no restriction), 1 (nearly not restricted) - 5 (very strongly restricted). Consequently higher scores mean a worse outcome.
Days the patient stays in the hospital, days at the intensive care unit up to one week post-surgery Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l Baseline, up to one day, two days and five days post-surgery Change from baseline to postoperative day 1 (POD1) to approx. POD2 to approx. POD 5; higher scores mean a worse outcome.
Trial Locations
- Locations (1)
UKGM Marburg
🇩🇪Marburg, Germany
UKGM Marburg🇩🇪Marburg, Germany