Clinical trial NCT04669379: Is an Online-tool Capable of Improving Patients' Outcomes After Surgery?
Official title: Preoperative Optimization of Patient's Expectations by the Use of an Online-Tool - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patients Undergoing Surgery
Keywords: Expectations
Preoperative intervention
placebo effect
surgery
clinical trial
recovery
online intervention
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly distributed to the intervention group (IG/EXPECT) or the control group (CG). The intervention group will receive a psychological preoperative online-intervention to optimize expectations. The control group will receive no intervention at all.
Primary purpose: TREATMENT

Brief summary: Recovery after the 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. However, the content of these interventions needs further examination. This study aims to examine if the developed preoperative intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome and postoperative recovery. Therefore an online-tool has been developed. Using an online-approach makes it possible to reach many patients taking as little time and cost as possible.

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.


Eligibility criteria: Inclusion Criteria:

* In-patient operation under general anesthetic
* 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

Primary outcomes:
measure: Change in Pain Disability Index (PDI) from Baseline to two days pre-surgery to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
Secondary outcomes:
measure: Change in The Amsterdam Preoperative Anxiety and Information Scale (APAIS) from Baseline to two days pre-surgery
timeFrame: Baseline, two days pre-surgery
measure: Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery
measure: Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to two days pre-surgery to one week post-surgery
timeFrame: Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery
measure: Change in The Control Attitudes Scale-Revised (CAS-R) from Baseline to one week post-surgery
timeFrame: Baseline, up to one week post-surgery
Other outcomes:
measure: Change in Patients' Illness Perception (Brief Illness Perception Questionnaire, B-IPQ) from Baseline to two days pre-surgery to one week post-surgery to three months after surgery
timeFrame: Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery
measure: Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in patients optimism (Life-Orientation-Test Revised, LOT-R) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Personality (Big Five Inventory, BFI-10)
timeFrame: Baseline
measure: Patients' experience with prior surgeries
timeFrame: Baseline
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Study officials:
affiliation: Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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