Preoperative Optimization of Cardiac Valve Patients' Expectations
NCT ID: NCT04502121
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
89 participants
INTERVENTIONAL
2020-07-17
2023-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group (IG)
EXPECT: Preoperative optimization of cardiac valve patient's expectations
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).
Standard of Care (SOC)
No interventions assigned to this group
Interventions
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EXPECT: Preoperative optimization of cardiac valve patient's expectations
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).
Eligibility Criteria
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Inclusion Criteria
* Age 18 or above
* Fluency in German
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Heart Centre Rotenburg
OTHER
Justus-Liebig University Gießen Medical Center
UNKNOWN
Philipps University Marburg
OTHER
Responsible Party
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Winfried Rief
Prof. Dr.
Principal Investigators
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Winfried Rief, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg
Ardawan Rastan, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Cardiac surgery University Hospital Gießen und Marburg
Locations
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UKGM Marburg
Marburg, , Germany
Countries
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References
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Auer CJ, Glombiewski JA, Doering BK, Winkler A, Laferton JA, Broadbent E, Rief W. Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis. Int J Behav Med. 2016 Feb;23(1):49-62. doi: 10.1007/s12529-015-9500-4.
Juergens MC, Seekatz B, Moosdorf RG, Petrie KJ, Rief W. Illness beliefs before cardiac surgery predict disability, quality of life, and depression 3 months later. J Psychosom Res. 2010 Jun;68(6):553-60. doi: 10.1016/j.jpsychores.2009.10.004. Epub 2009 Dec 5.
Laferton JA, Kube T, Salzmann S, Auer CJ, Shedden-Mora MC. Patients' Expectations Regarding Medical Treatment: A Critical Review of Concepts and Their Assessment. Front Psychol. 2017 Feb 21;8:233. doi: 10.3389/fpsyg.2017.00233. eCollection 2017.
Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Löwe, B., Spitzer, R. L., Zipfel, S., & Herzog, W. (2002). PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer.
Rector TS, Kubo SH, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol. 1993 May 1;71(12):1106-7. doi: 10.1016/0002-9149(93)90582-w. No abstract available.
Rief, W., & Glombiewski, J. A. (2016). Erwartungsfokussierte Psychotherapeutische Interventionen (EFPI). Verhaltenstherapie, 26(1), 47-54.
Salzmann, S., Laferton, J., Auer, C., Shedden-Mora, M., Wambach, K., & Rief, W. (2018). Patientenerwartungen optimieren: Beschreibung einer präoperativen Kurzintervention am Beispiel von Patienten vor einer Bypass-Operation. Verhaltenstherapie, 28(3), 157-165.
Gaab, J. (2009). PASA-Primary Appraisal Secondary Appraisal-Ein Fragebogen zur Erfassung von situations-bezogenen kognitiven Bewertungen. Verhaltenstherapie, 19(2), 114-115.
Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.
Rammstedt, B. und O. P. John, 2007: Measuring personality in one minute or less: A 10-item short version of the Big Five Inventory in English and German. Journal of Research in Personality 41: 203-212
Horn N, Gartner L, Rastan AJ, Andrasi TB, Lenz J, Boning A, Salzmann-Djufri M, Puvogel U, Niemann B, Genovese M, Habash S, Euteneuer F, Rief W, Salzmann S. Effects of a preoperative psychological expectation-focused intervention in patients undergoing valvular surgery - the randomized controlled ValvEx (valve patients' expectations) study. Am Heart J. 2025 Apr;282:156-169. doi: 10.1016/j.ahj.2025.01.006. Epub 2025 Jan 17.
Horn N, Gartner L, Rastan AJ, Andrasi TB, Lenz J, Boning A, Salzmann-Djufri M, Puvogel U, Genovese M, Kus S, Rief W, Salzmann S. Preoperative optimization of cardiac valve patients' expectations: Study protocol of the randomized controlled ValvEx-trial. Front Cardiovasc Med. 2023 Mar 2;10:1105507. doi: 10.3389/fcvm.2023.1105507. eCollection 2023.
Other Identifiers
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ValvEx
Identifier Type: -
Identifier Source: org_study_id
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