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Clinical Trials/NCT04502121
NCT04502121
Completed
Not Applicable

Preoperative Optimization of Cardiac Valve Patients' Expectations - a Randomized Controlled Trial

Philipps University Marburg Medical Center1 site in 1 country89 target enrollmentJuly 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Valve Disease
Sponsor
Philipps University Marburg Medical Center
Enrollment
89
Locations
1
Primary Endpoint
Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2020
End Date
July 7, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Winfried Rief

Prof. Dr.

Philipps University Marburg Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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)
  • Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery(Baseline, one day pre-surgery)
  • 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)
  • 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)

Study Sites (1)

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