Patients Undergoing Surgery
Conditions
Keywords
Expectations, Preoperative intervention, placebo effect, surgery, clinical trial, recovery, online intervention
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.
Interventions
BEHAVIORALEXPECT: 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.
Sponsors
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Disability Index (PDI) from Baseline to two days pre-surgery to one week post-surgery to three months post-surgery | Baseline, 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
| Measure | Time frame | Description |
|---|---|---|
| Change in The Amsterdam Preoperative Anxiety and Information Scale (APAIS) from Baseline to two days pre-surgery | Baseline, 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 |
| Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery | 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 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). |
| Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery | Baseline, two days pre-surgery, 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. |
| Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to two days pre-surgery to one week post-surgery | Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery | Items range from 0 (absolutely wrong) - 6 (absolutely right). Higher scores mean a better outcome. |
| Change in The Control Attitudes Scale-Revised (CAS-R) from Baseline to one week post-surgery | Baseline, up 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery | 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. |
| Change in patients optimism (Life-Orientation-Test Revised, LOT-R) from Baseline to one week post-surgery to three months post-surgery | 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. |
| Personality (Big Five Inventory, BFI-10) | Baseline | Items range from 1 (disagree strongly) - 5 (agree strongly). The questionnaire includes the scales openness to experience, conscientiousness, extraversion, agreeableness and neuroticism |
| Patients' experience with prior surgeries | 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) |
| 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 | Baseline, two days pre-surgery, 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, and identity). 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. |
Countries
Germany
Outcome results
None listed