Is an Online-tool Capable of Improving Patients' Outcomes After Surgery?
NCT ID: NCT04669379
Last Updated: 2024-08-09
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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TERMINATED
NA
29 participants
INTERVENTIONAL
2021-06-15
2022-11-24
Brief Summary
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Patients who undergo surgery in the next two weeks and want to participate in the study will be asked for the planned surgical procedure. There will be a filter (stratum) for surgery. Patients with the same kind of surgery are randomized into two groups (Control vs. intervention group) after they've filled some questionnaires at the baseline assessment. Following this, the intervention group will participate in the psychological online intervention (around 30 minutes). The intervention will focus on the treatment outcome expectations and personal control expectations to increase patients' positive expectations. The control group will receive no psychological intervention. Both groups will fill out questionnaires again in the evening, two days before the surgery, around one week after the surgery, and three months after the surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group (IG/EXPECT)
EXPECT: Preoperative optimization of patient's expectations
Patients work through an online-tool (around 30 minutes). This preoperative intervention aims to optimize patients' expectations by focusing on positive and realistic expectations regarding the surgery-benefits and recovery process, giving information, and giving advice for coping resources.
Standard of Care (SOC)
No interventions assigned to this group
Interventions
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EXPECT: Preoperative optimization of patient's expectations
Patients work through an online-tool (around 30 minutes). This preoperative intervention aims to optimize patients' expectations by focusing on positive and realistic expectations regarding the surgery-benefits and recovery process, giving information, and giving advice for coping resources.
Eligibility Criteria
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Inclusion Criteria
* Age 18 or above
* Fluency in German
* Informed consent
Exclusion Criteria
* Emergency surgery
18 Years
ALL
No
Sponsors
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Philipps University Marburg
OTHER
Responsible Party
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Winfried Rief
Professor, Dr.
Principal Investigators
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Winfried Rief, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg
Locations
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Department of Clinical Psychology and Psychotherapy, Philipps-University 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.
Gaab, J. (2009). PASA - Primary Appraisal Secondary Appraisal - Ein Fragebogen zur Erfassung von situationsbezogenen kognitiven Bewertungen, Verhaltenstherapie,19:114-115
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.
Löwe, B., Spitzer, R. L., Zipfel, S., & Herzog, W. (2002). PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer.
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.
Moser DK, Riegel B, McKinley S, Doering LV, Meischke H, Heo S, Lennie TA, Dracup K. The Control Attitudes Scale-Revised: psychometric evaluation in three groups of patients with cardiac illness. Nurs Res. 2009 Jan-Feb;58(1):42-51. doi: 10.1097/NNR.0b013e3181900ca0.
Rief, W., & Glombiewski, J. A. (2016). Erwartungsfokussierte Psychotherapeutische Interventionen (EFPI). Verhaltenstherapie, 26(1), 47-54.
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.
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.
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.
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 orless: A 10-item short version of the Big Five Inventory in English and German.Journal of Research in Personality 41: 203-212
Other Identifiers
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Online-Tool Erwartungen prä-OP
Identifier Type: -
Identifier Source: org_study_id
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