Is an Online-tool Capable of Improving Patients' Outcomes After Surgery?

Study Overview
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Brief Summary
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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.

Official Title
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Preoperative Optimization of Patient's Expectations by the Use of an Online-Tool - a Randomized Controlled Trial

Conditions
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Patients Undergoing Surgery

Intervention / Treatment
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* Behavioral: EXPECT: Preoperative optimization of patient's expectations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (IG/EXPECT)<br> | Behavioral: EXPECT: Preoperative optimization of patient's expectations<br>* 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.<br>|
| No Intervention: Standard of Care (SOC)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Disability Index (PDI) from Baseline to two days pre-surgery to one week post-surgery to three months post-surgery | Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome. | Baseline, up to one week post-surgery, up to three months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Amsterdam Preoperative Anxiety and Information Scale (APAIS) from Baseline to two days 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 | Baseline, two days pre-surgery | 
| Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery 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 andno. 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). | Baseline, up to one week post-surgery, up to three months post-surgery | 
| Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery | Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome. | Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery | 
| Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to two days pre-surgery to one week post-surgery | Items range from 0 (absolutely wrong) - 6 (absolutely right). Higher scores mean a better outcome. | Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery | 
| Change in The Control Attitudes Scale-Revised (CAS-R) from Baseline to one week post-surgery | Items range from 0 (not at all) - 8 (absolutely right). Higher scores mean a better outcome (after reversion of the inverse items 5 and 8). | Baseline, up to one week post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, Expectations, Preoperative intervention, placebo effect, clinical trial, recovery, online intervention