Patients Undergoing Surgery Clinical Trial
Official title:
Preoperative Optimization of Patient's Expectations by the Use of an Online-Tool - a Randomized Controlled Trial
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.
| Status | Recruiting |
| Enrollment | 293 |
| Est. completion date | September 30, 2022 |
| Est. primary completion date | June 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg | Marburg |
| Lead Sponsor | Collaborator |
|---|---|
| Philipps University Marburg Medical Center |
Germany,
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | 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. | Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery | |
| Other | Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery | Items range from 1 (absolutely wrong) - 5 (absolutely right). Higher scores mean a better outcome. | Baseline, up to one week post-surgery, up to three months post-surgery | |
| Other | Change in patients optimism (Life-Orientation-Test Revised, LOT-R) from Baseline to one week post-surgery to three months post-surgery | Items range from 1 (absolutely) - 5 (absolutely not). Higher scores mean a worse outcome. | Baseline, up to one week post-surgery, up to three months post-surgery | |
| Other | Personality (Big Five Inventory, BFI-10) | Items range from 1 (disagree strongly) - 5 (agree strongly). The questionnaire includes the scales "openness to experience", "conscientiousness", "extraversion", agreeableness and neuroticism | Baseline | |
| Other | Patients' experience with prior surgeries | 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) | Baseline | |
| Primary | 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 | 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 | |
| Secondary | 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" and"no". 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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