CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
EXPECT: Preoperative optimization of cardiac valve patient's expectationsbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04502121
NCT04502121N/ACompleted

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

Philipps University Marburg·interventional·Posted Aug 6, 2020·Updated Sep 21, 2023

In Brief

A clinical study evaluating EXPECT: Preoperative optimization of cardiac valve patient's expectations for Cardiac Valve Disease. Completed, enrolled 89 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 6, 2020
Enrollment StartJul 17, 2020
Primary CompletionNov 29, 2022
Study CompletionJul 7, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.9 years ago

Interventions

EXPECT: Preoperative optimization of cardiac valve patient's expectationsbehavioral

The psychological, preoperative intervention follows a treatment manual. Patients get a personal intervention one day before surgery (30-40 minutes). It includes the development of an individual, subjectively perceived disease model, the treatment outcome expectations and the personalized outcome expectancy. Additionally they get two booster telephone calls 4 and 8 weeks after the surgery to recall the discussed topics and to talk about their recovery process (10-15 minutes).