Preoperative Optimization of Cardiac Valve Patients' Expectations (ValvEx)

Philipps University

Status: Completed

Conditions: Cardiac Valve Disease

Treatments: Behavioral: EXPECT: Preoperative optimization of cardiac valve patient's expectations

Study type: Interventional

Funder types: Other

Identifiers

NCT04502121

ValvEx

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are scheduled for elective cardiac valve procedure
• Age 18 or above
• Fluency in German
• Informed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 2 patient groups

Intervention group (IG)

Experimental group

Treatment:

Behavioral: EXPECT: Preoperative optimization of cardiac valve patient's expectations

Standard of Care (SOC)

No Intervention group