Virtual reality and psychoeducation to reduce preoperative anxiety in oncology patients: Protocol of a randomized controlled trial

peer reviewedBackground. Many women with breast cancer who are scheduled for surgery suffer from preoperative anxiety (Majumdar et al., 2019). Unmanaged preoperative anxiety can have a negative impact on the intra- and postoperative periods (e.g., pain, increased use of analgesics and anesthetics) (Kulkarni et al., 2017; Stamenkovic et al., 2018). The present study aims to examine the benefit of the combination of two psychological tools during the preoperative phase: psychoeducation on relaxation and relaxing environments through virtual reality (VR). Methods. One hundred and twenty women with breast cancer undergoing initial surgery will be enrolled in this single-center, three-arm randomized controlled trial. Patients will be randomized at 1:1:1 ratio to one of the following groups: psychoeducation + VR; only psychoeducation; control group receiving standard treatment. Primary outcomes are preoperative anxiety, worries, and relaxation's indicators measured by visual analog scales. Secondary clinical outcomes are perioperative experience (e.g., pain, comfort), heart rate, anesthesic and surgical data (e.g., anesthesia and analgesia requirement). Data will be collected at baseline, 21 days before surgery (T1), 14 days before surgery (T2), 7 days before surgery (T3), the day of surgery (T4), the day after surgery (T5), and ∼1 month after surgery (T6). Expected results. We should observe a significant difference between the outcomes of the two experimental groups and those of the control group (i.e., decrease in preoperative anxiety and worry, improvement in relaxation and perioperative experience). Furthermore, VR immersions could enhance the relaxation learning. Thus, we should also observe a significant difference between the results of this group and the group receiving psychoeducation only. Discussion. The combined action of psychoeducation and VR could become a real alternative to reduce anxiety in women awaiting for breast cancer surgery. This new proactive approach may provide a much-needed, easy-to-use, non-pharmacological relaxation intervention to improve the health of surgical patients

Petrifying attachments: fear and safety in Jeanette Winterson's tanglewreck and the battle of the sun

This article focuses on Jeanette Winterson's two most extended works of fiction for children, Tanglewreck and The Battle of the Sun, identifying them as narratives of longing and adventure engaging directly with questions of childhood fear and safety. In 2007 I wrote an article on Winterson's adult fiction which focused on her use of vertical imagery. Using such vertiginous drops, I argued, Winterson explores the perilous opportunities afforded by disengaging from a woman-centred storytelling tradition, thus enabling her to 'go it alone'. In Tanglewreck and The Battle of the Sun, these vertical images return and are again connected with questions of attachment and disengagement, yet now with an increasingly overt agenda of negotiating maternal separation anxiety. In Winterson's 2011 memoir, Why Be Happy When You Could Be Normal?, the journey of the first-person narrator, as she travels from child to adulthood, is shrouded in fears linked to lost origins and a safe sense of belonging. As this article shows, these are also the issues facing Silver and Jack, the child protagonists of Tanglewreck and The Battle of the Sun. © 2013 Edinburgh University Press

Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia

International audienceImportance Severe pneumonia with hyperinflammation and elevated interleukin-6 is a common presentation of coronavirus disease 2019 (COVID-19).Objective To determine whether tocilizumab (TCZ) improves outcomes of patients hospitalized with moderate-to-severe COVID-19 pneumonia.Design, Setting, and Particpants This cohort-embedded, investigator-initiated, multicenter, open-label, bayesian randomized clinical trial investigating patients with COVID-19 and moderate or severe pneumonia requiring at least 3 L/min of oxygen but without ventilation or admission to the intensive care unit was conducted between March 31, 2020, to April 18, 2020, with follow-up through 28 days. Patients were recruited from 9 university hospitals in France. Analyses were performed on an intention-to-treat basis with no correction for multiplicity for secondary outcomes.Interventions Patients were randomly assigned to receive TCZ, 8 mg/kg, intravenously plus usual care on day 1 and on day 3 if clinically indicated (TCZ group) or to receive usual care alone (UC group). Usual care included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants.Main Outcomes and Measures Primary outcomes were scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 4 and survival without need of ventilation (including noninvasive ventilation) at day 14. Secondary outcomes were clinical status assessed with the WHO-CPS scores at day 7 and day 14, overall survival, time to discharge, time to oxygen supply independency, biological factors such as C-reactive protein level, and adverse events.Results Of 131 patients, 64 patients were randomly assigned to the TCZ group and 67 to UC group; 1 patient in the TCZ group withdrew consent and was not included in the analysis. Of the 130 patients, 42 were women (32%), and median (interquartile range) age was 64 (57.1-74.3) years. In the TCZ group, 12 patients had a WHO-CPS score greater than 5 at day 4 vs 19 in the UC group (median posterior absolute risk difference [ARD] −9.0%; 90% credible interval [CrI], −21.0 to 3.1), with a posterior probability of negative ARD of 89.0% not achieving the 95% predefined efficacy threshold. At day 14, 12% (95% CI −28% to 4%) fewer patients needed noninvasive ventilation (NIV) or mechanical ventilation (MV) or died in the TCZ group than in the UC group (24% vs 36%, median posterior hazard ratio [HR] 0.58; 90% CrI, 0.33-1.00), with a posterior probability of HR less than 1 of 95.0%, achieving the predefined efficacy threshold. The HR for MV or death was 0.58 (90% CrI, 0.30 to 1.09). At day 28, 7 patients had died in the TCZ group and 8 in the UC group (adjusted HR, 0.92; 95% CI 0.33-2.53). Serious adverse events occurred in 20 (32%) patients in the TCZ group and 29 (43%) in the UC group (P = .21).Conclusions and Relevance In this randomized clinical trial of patients with COVID-19 and pneumonia requiring oxygen support but not admitted to the intensive care unit, TCZ did not reduce WHO-CPS scores lower than 5 at day 4 but might have reduced the risk of NIV, MV, or death by day 14. No difference on day 28 mortality was found. Further studies are necessary for confirming these preliminary results.Trial Registration ClinicalTrials.gov Identifier: NCT0433180

Effect of anakinra versus usual care in adults in hospital with COVID-19 and mild-to-moderate pneumonia (CORIMUNO-ANA-1): a randomised controlled trial

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Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial

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