Is an Online-tool Capable of Improving Patients' Outcomes After Surgery?
- Conditions
- Patients Undergoing Surgery
- Registration Number
- NCT04669379
- Lead Sponsor
- Philipps University Marburg Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 29
- In-patient operation under general anesthetic
- Age 18 or above
- Fluency in German
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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" 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).
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).
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 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
Trial Locations
- Locations (1)
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
🇩🇪Marburg, Germany