A digital application and augmented physician rounds reduce postoperative pain and opioid consumption after primary total knee replacement (TKR): a randomized clinical trial.

BACKGROUND: Severe postoperative pain not only is a considerable burden for patients but also leads to overprescription of opioids, resulting in considerable health concerns. The remarkable development of new technologies in the health care system provides novel treatment opportunities in this area and could exploit the additional placebo effect, provide added value for patients, and at the same time support hospital staff. We aimed to test the pain- and opioid intake-reducing effects of enhanced postoperative pain management by boosting pain medication by using a technical application and/or augmented physician rounds. METHODS: In a four-arm, randomized clinical trial, 96 patients (24 patients per group) scheduled for a total knee replacement (TKR) were randomized into four groups for four postoperative days: an "application" group (APP) with information via an iPad-based application; a "doctor" group (DOC) with augmented physician rounds; a combination group (APP+DOC), which received both interventions; and a "treatment as usual" group (TAU) as a baseline with no additional intervention besides the standard care which consists of standardized medication, regular physician rounds, and physiotherapy. Postoperative pain and opioid requirements pre- and postoperatively until hospital discharge were recorded. RESULTS: The difference between post- and preoperative pain was significantly different between the groups (P=.02, partial η2=.10). APP+DOC experienced greater postoperative pain relief than DOC (mean: 2.3 vs. 0.7, 95% CI: 0.08-3.09; P=.04) and TAU (mean 2.3 vs. 0.1; 95% CI: 0.69-3.71; P=.005), respectively, the difference compared to APP (mean 2.3 vs. 1.7; 95% CI -1.98-1.76) was not significant. Opioid consumption differed significantly between groups (P=.01, partial η2=.12). APP+DOC (72.9 mg) and DOC (75.4 mg) consumed less oxycodone than APP (83.3 mg) and TAU (87.9 mg; 95% CI: 2.9-22.1; P=.003). APP+DOC consumed significantly less oxycodone than DOC (d=0.2-0.4). There were no significant group differences in NSAID and Morphine sulfate consumption. Patients in APP+DOC were more satisfied with their treatment than patients in TAU (P=.03, partial η2=.09). CONCLUSIONS: The combination of an innovative digital app, which implements open drug administration and augmented physician rounds that support the doctor-patient relationship can significantly improve postoperative pain management. TRIAL REGISTRATION: The protocol was approved by the local ethics committee of the ethical commission of the German Psychological Society (Deutsche Gesellschaft für Psychologie; DGPs). The study was registered at DRKS.de (identifier: DRKS00009554).

[Treatment expectations for postoperative pain]. / Behandlungserwartungen bei postoperativen Schmerzen.

BACKGROUND: Preoperative treatment expectations have a significant influence on postoperative pain and treatment outcomes. Positive expectations are an important mechanism of the placebo effect and negative expectations are an important mechanism of the nocebo effect. OBJECTIVES: What is the influence of treatment expectations, how are they assessed in the clinical setting, and how can the findings be implemented in clinical practice? METHODS: A literature search was performed using the keywords "expectation" AND ("postoperative" OR "surgery"). All English and German articles were selected. In addition, the bibliographies of the articles found were examined and incorporated. RESULTS: A total of 158 articles were found, 49 of which investigate expectations and include postoperative treatment outcomes. Most articles investigate expectations only at baseline to ensure that groups do not differ preoperatively. The studies that prospectively examine the influence of expectations apply very different measurement methods to investigate expectancy constructs. Thus, comparison across studies is difficult. There are few studies examining whether and how expectations can be influenced perioperatively, and who developed practice-relevant interventions to change them. CONCLUSION: Valid and reliable measurement tools should be applied in clinical trials for a more robust investigation of treatment expectations. Further studies should address possible intervention options so that treatment expectations can also be incorporated into standard clinical care.

The Influence of Preoperative Mood and Treatment Expectations on Early Postsurgical Acute Pain After a Total Knee Replacement.

Background: Reducing postoperative pain immediately after surgery is crucial because severe postoperative pain reduces quality of life and increases the likelihood that patients develop chronic pain. Even though postoperative pain has been widely studied and there are national guidelines for pain management, the postoperative course is differently from one patient to the next. Different postoperative courses could be explained by factors related to the treatment context and the patients. Preoperative emotional states and treatment expectations are significant predictors of postoperative pain. However, the interaction between emotional states and preoperative treatment expectations and their effect on postoperative pain have not yet been studied. The aim of our study was to identify the interaction between emotional states, treatment expectation and early postsurgical acute pain. Methods: In this prospective clinical trial, we enrolled patients who had received a TKR at a German hospital between October 2015 and March 2019. Patients rated their preoperative pain on a numeric rating scale (NRS) 0-10 (0 = no pain and 10 = worst pain imaginable), their emotional states preoperatively on the Pain and State of Health Inventory (PHI), their preoperative treatment expectations on the Stanford Expectation of Treatment Scale (SETS), and their postoperative level of pain on a NRS 0-10. Findings: The questionnaires were completed by 122 patients (57% female). Emotional states predict negative treatment expectation F(6, 108) = 8.32, p < 0.001, with an excellent goodness-of-fit, R2 = 0.31. Furthermore, a mediator analysis revealed that the indirect effects and therefore relationship between the emotional states sad (ab = 0.06, 95% CI[0.01, 0.14]), anxious (ab = 0.13, 95% CI[0.04, 0.22]), and irritable (ab = 0.09, 95% CI[0.03, 0.17]) and postoperative pain is fully mediated by negative treatment expectations. Whereas the emotional states tired (ab = 0.09, 95% CI[0.03, 0.17]), dizzy/numb (ab = 0.07, 95% CI[0.01, 0.20]), weak (ab = 0.08, 95% CI[0.03, 0.16] are partially mediated by negative treatment expectations. Conclusion: The relationship between emotional states and postoperative pain is mediated by negative treatment expectations. Therefore, innovative treatment strategies to reduce postoperative pain should focus on eliminating negative treatment expectation through establishing a differentiated preoperative expectation management program that also focuses on emotional states.

Optimising treatment expectations in chronic lower back pain through observing others: a study protocol for a randomised clinical trial.

INTRODUCTION: Chronic lower back pain (CLBP) is a frequent cause of medical consultations worldwide, and it results in decreased quality of life and disability. Current treatments for CLBP are often not effective, and alternatives are urgently needed. Three promising possibilities have emerged: (1) open-label placebo treatment reduces chronic pain, (2) placebo treatment is as efficacious as opioid treatment with a high correlation between patient expectation and treatment outcome, and (3) observing positive effects in another patient can improve functional capacity. We hypothesise that treatment expectations can be positively influenced through social observation and improve treatment outcome. METHODS AND ANALYSIS: In our clinical trial, we will randomise patients with CLBP into five groups. Two groups receive either a 3 week course of treatment with an analgesic (ANA) (metamizole/dipyrone) or with open-label placebos (OLP). For one of each group, we will build treatment expectations through observational learning and assess its impact on the treatment. For this purpose, one group each will watch either a positive or a neutral video. The intervention groups will be compared with a control group that will not be given any medication or observational learning. Participants will be recruited via all institutions in the Hamburg metropolitan area that treat patients with CLBP. Patients are eligible for inclusion if they are at least 18 years or older, have CLBP (of at least 3 months duration), and agree to potentially receive an active ANA or an OLP. Patients with pain-related "red flags" will be excluded. The study requires 150 participants (30 participants per group) to assess the differences in the primary outcome, pain intensity. Secondary outcomes include changes in treatment expectations, anxiety, comorbid depression, stress-related neuroendocrine measures, functional and structural connectivity, functional capacity, and ANA consumption. All outcomes and treatment expectations will be measured before and after the intervention and 3 months post-intervention. ETHICS AND DISSEMINATION: Ethical approval was obtained in January 2020 from the Hamburg Medical Ethics Council (ref number PV7067). Outcomes will be disseminated through publications in peer-reviewed journals and presentations at national and international conference meetings. TRIAL REGISTRATION NUMBER: The approved trial protocol was registered at the German Clinical Trials Register (DRKS) and can be found at drks.de (Identifier: DRKS00024418).

Development and Validation of the Pain and State of Health Inventory (PHI): Application for the Perioperative Setting.

Currently, general measurements and evaluations of the quality of recovery are difficult because no adequate measuring tools are available. Therefore, there is an urgent need for a universal tool that assesses patient-relevant criteria-postoperative pain, state of health, and somatic parameters. For this purpose, a pain and state of health inventory (PHI, Schmerz- und Befindlichkeitsinventar (SBI) in German) has been developed. In this study, we describe its development and validation. The development phase was led by an expert panel and was divided into three subphases: determining the conceptual structure, testing the first editions, and adjusting the inventory for a finalized edition. For the purpose of validation, the PHI was filled in by 132 patients who have undergone total knee replacement and was analyzed using principal component analysis. Construct validity was tested by correlating the items with validated questionnaires. The results showed that the inventory can test pain, state of health, and somatic parameters with great construct validity. Furthermore, the inventory is accepted by patients, map changes, and supports to initiate adequate treatment. In conclusion, the PHI is a universal tool that can be used to assess the quality of recovery in the perioperative setting and allow immediate intervention.

Clinical Use of Placebo Effects in Patients With Pain Disorders.

The analgesic placebo effect is well documented by numerous studies. Many important influencing factors, however, are yet to be discovered. In the arena of placebo effects and clinical implications, expectancies play a central role. Expectancies are shaped by processes of classical and social learning as well as verbal instructions and are strongly related to emotional factors. Expectancies trigger a cascade of endogenous opioids and non-opioids, which alter the experience of pain. For clinical application it is important to know, that placebo research yields ethical possibilities to use placebo effects without deception and without using placebos. Since placebo effects contribute to responses to active analgesics, it is feasible to enhance patients' benefits from pain treatments by increasing the additional placebo effect. There are several possibilities to use the placebo effects via shaping and adapting information about analgesic medication and via associating medication intake with a positive context. A positive patient-clinician communication atmosphere is very important to generate clinically meaningful placebo effects in pain medicine.

No Differential Effects of Neural and Psychological Explanations of Psychopathy on Moral Behavior.

Research in neurocriminology has explored the link between neural functions and structures and the psychopathic disposition. This online experiment aimed to assess the effect of communicating the neuroscience of psychopathy on the degree to which lay people exhibited attitudes characteristic of psychopathy in particular in terms of moral behavior. If psychopathy is blamed on the brain, people may feel less morally responsible for their own psychopathic tendencies. In the study, participants read false feedback about their own psychopathic traits supposedly inferred from their Facebook likes, described either in neurobiological or cognitive terms. Participants were randomly allocated to read that they either had above-average or below-average psychopathic traits. We found no support for the hypothesis that the neuroscientific explanation of psychopathy influences moral behavior. This casts doubt on the fear that communicating the neuroscience of psychopathy will promote psychopathic attitudes.

Communicating the Neuroscience of Psychopathy and Its Influence on Moral Behavior: Protocol of Two Experimental Studies.

Neuroscience has identified brain structures and functions that correlate with psychopathic tendencies. Since psychopathic traits can be traced back to physical neural attributes, it has been argued that psychopaths are not truly responsible for their actions and therefore should not be blamed for their psychopathic behaviors. This experimental research aims to evaluate what effect communicating this theory of psychopathy has on the moral behavior of lay people. If psychopathy is blamed on the brain, people may feel less morally responsible for their own psychopathic tendencies and therefore may be more likely to display those tendencies. An online study will provide participants with false feedback about their psychopathic traits supposedly based on their digital footprint (i.e., Facebook likes), thus classifying them as having either above-average or below-average psychopathic traits and describing psychopathy in cognitive or neurobiological terms. This particular study will assess the extent to which lay people are influenced by feedback regarding their psychopathic traits, and how this might affect their moral behavior in online tasks. Public recognition of these potential negative consequences of neuroscience communication will also be assessed. A field study using the lost letter technique will be conducted to examine lay people's endorsement of neurobiological, as compared to cognitive, explanations of criminal behavior. This field and online experimental research could inform the future communication of neuroscience to the public in a way that is sensitive to the potential negative consequences of communicating such science. In particular, this research may have implications for the future means by which neurobiological predictors of offending can be safely communicated to offenders.