Background: Pain is a clinical feature of COVID-19, however, data about persistent pain after hospital discharge, especially among ICU survivors is scarce. The aim of this study was to explore the incidence and characteristics of new-onset pain and its impact on Health-Related Quality of Life (HRQoL), and to quantify the presence of mood disorders in critically ill COVID-19 survivors.Methods: This is a preliminary report of PAIN-COVID trial (NCT04394169) presenting a descriptive analysis in critically ill COVID-19 survivors, following in person interview 1 month after hospital discharge. Pain was assessed using the Brief Pain Inventory, the Douleur Neuropathique 4 questionnaire and the Pain Catastrophizing Scale. HRQoL was evaluated with the EQ 5D/5L, and mood disorders with the Hospital Anxiety and Depression Scale (HADS).Results: From 27 May to 19 July 2020, 203 patients were consecutively screened for eligibility, and 65 were included in this analysis. Of these, 50.8% patients reported new-onset pain; 38.5% clinically significant pain (numerical rating score ≥3 for average pain intensity); 16.9% neuropathic pain; 4.6% pain catastrophizing thoughts, 44.6% pain in ≥2 body sites and 7.7% widespread pain. Patients with new-onset pain had a worse EQ-VAS and EQ index value (p < 0.001). Pain intensity was negatively correlated to both the former (Spearman ρ: −0.546, p < 0.001) and the latter (Spearman ρ: −0.387, p = 0.001). HADS anxiety and depression values equal or above eight were obtained in 10.8% and 7.7% of patients, respectively. Conclusion: New-onset pain in critically ill COVID-19 survivors is frequent, and it is associated with a lower HRQoL. Trial registration No.: NCT04394169. Registered 19 May 2020. https://clini caltr ials.gov/ct2/show/NCT04 394169. Significance: A substantial proportion of severe COVID-19 survivors may develop clinically significant persistent pain, post-intensive care syndrome and chronic ICU-related pain. Given the number of infections worldwide and the unprecedented size of the population of critical illness survivors, providing

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Background Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge. Methods The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm). Discussion This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic. Trial registration This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors’ institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov (NCT04394169).

Background: To explore the incidence and characteristics of new-onset pain, its impact on quality of life (HRQoL), and to quantify the presence of mood disorders in critically ill COVID-19 survivors. Methods: This is a preliminary report of PAIN-COVID clinical trial (NCT04394169) presenting a descriptive analysis in critical ill COVID 19 survivors one month after hospital discharge. Pain was assed using the Brief Pain Inventory short form, Douleur Neuropathique 4 Questions test and Pain Catastrophizing Scale. Health related quality of life (HRQoL) was evaluated with EQoL-5D/5L and mood disorders with Hospital Anxiety and Depression test (HAD).Results: From May 27th to July 19th 2020, 203 patients were consecutively screened for eligibility and 65 were finally included in this analysis. In 33 (50.8%) patients a new-onset pain was reported: 18 (54.5%) reported clinically significant intense pain, 11 (33.3%) a positive screening for neuropathic pain, 3 (9.1%) clinically relevant pain catastrophizing thoughts, 29 (87.9%) pain in ≥2 body sites and 5 (15.2%) widespread pain. Median EQoL-5D/5L index value and visual analogue scale was 0.8 (IQR 0.57-0.87) and 70 (IQR 60-80) respectively. Pain intensity was negatively correlated both to the former (Spearman Rho: -0.546, p<0.001) and to the latter (Spearman Rho: -0.387, p=0.001). A HAD anxiety and depression value over 8 were obtained in 7 (10,8 %) and 5 (7,7%) of patients, respectively.Conclusion: The incidence of new-onset pain in critically ill COVID-19 survivors is high and it was associated with a lower HRQoL. Trial registration: NCT04394169. Registered 19 May 2020. https://clinicaltrials.gov/ct2/show/NCT04394169