Skip to main content
OpenTrials
Completed

NCT Number: NCT04502121

Preoperative Optimization of Cardiac Valve Patients' Expectations

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UKGM Marburg

Marburg, 35037, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXPECT: Preoperative optimization of cardiac valve patient's expectations

Behavioral

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).

Primary outcomes

  1. 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

  1. Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery

    Time frame: 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.

  2. Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery

    Time frame: 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).

  3. Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery

    Time frame: 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.

  4. Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery

    Time frame: 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.

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

    Time frame: 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.

  6. Days the patient stays in the hospital, days at the intensive care unit

    Time frame: up to one week post-surgery

  7. Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l

    Time frame: 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.

Other outcomes

  1. Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to one day pre-surgery to one week post-surgery

    Time frame: Baseline, one day pre-surgery, up to one week post-surgery

    Items range from 0 (absolutely wrong) - 6 (absolutely right). Higher scores mean a better outcome.

  2. Change in Patients' Illness Perception (Brief Illness Perception Questionnaire, B-IPQ) from Baseline to 1 week post-surgery to 3 months after surgery

    Time frame: Baseline, up to one week post-surgery, up to three months post-surgery

    The B-IPQ surveys the cognitive and emotional representations of illness. Item 1-5 measure cognitive illness representations (consequences, timeline, personal control, treatment control, andidentity). Item 6 and 8 quantify emotional representations (concern & emotions). Item 7 assesses illness comprehensibility. Item 9 is an open question (three most important causal factors in their illness). Items range from 0-10: item 1: no disability at all to very strong disability, item 2: really short to forever, item 3: no control at all zo extreme control, item 4: not at all to extremely helpful, item 5: no complaints at all to very much and strong complaints, item 6: no worries at all to extreme worries, item 7: not at all to very clear, item 8: emotionally not included at all to emotional extremely included.

  3. Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery

    Time frame: Baseline, up to one week post-surgery, up to three months post-surgery

    Items range from 1 (absolutely wrong) - 5 (absolutely right). Higher scores mean a better outcome.

  4. Change in patients optimism (Life-Orientation-Test Revised, LOT-R) from Baseline to one week post-surgery to three months post-surgery

    Time frame: Baseline, up to one week post-surgery, up to three months post-surgery

    Items range from 1 (absolutely) - 5 (absolutely not). Higher scores mean a worse outcome.

  5. Personality (Big Five Inventory, BFI-10)

    Time frame: Baseline

    Items range from 1 (disagree strongly) - 5 (agree strongly). The questionnaire includes the scales "openness to experience", "conscientiousness", "extraversion", agreeableness and neuroticism.

  6. Patients' experience with prior surgeries

    Time frame: Baseline

    Rating of experience with own prior surgeries. Rating of experience with surgeries of close others. First patients are asked if they or close others had a prior surgery before (yes/no). If they answer yes, they are asked to rate their or their close others experience (item ranges from 1 (very bad) - 5 (very good).

  7. Surgery procedure (planned and realized)

    Time frame: Baseline, up to one week post-surgery

    The planned and the realized surgical approach (minimally invasive or open) will be noted.

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Heart Centre Rotenburg
  • Justus-Liebig University Gießen Medical Center

Registry information

Official study title

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

Acronym: ValvEx

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 6, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.