Revista espanola de anestesiologia y reanimacion · 2024
Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Ojeda A, Calvo A, Cuñat T, Mellado-Artigas R, Costas-Carrera A, Sánchez-Rodriguez M M, Comino-Trinidad O, Aliaga J, Arias M, Martínez-Pallí G, Dürsteler C, Ferrando C
Аннотация
BACKGROUND: Critical COVID-19 survivors are at risk of developing Post-intensive Care Syndrome (PICS) and Chronic ICU-Related Pain (CIRP). We determined whether a specific care program improves the quality of life (QoL) of patients at risk of developing PICS and CIRP after COVID-19.
METHODS: The PAIN-COVID trial was a parallel-group, single-centre, single-blinded, randomized controlled trial. The intervention consisted of a follow up program, patient education on PICS and pain, and a psychological intervention based on Rehm's self-control model in patients with abnormal depression scores (≥8) in the Hospital Anxiety and Depression Scale (HADS) at the baseline visit. QoL was evaluated with the 5-level EQ 5D (EQ 5D 5 L), mood disorders with the HADS, post-traumatic stress disorder (PTSD) with the PCL-5 checklist, and pain with the Brief Pain Inventory short form, the Douleur Neuropathique 4 questionnaire, and the Pain Catastrophizing Scale. The primary outcome was to determine if the program was superior to standard-of-care on the EQ visual analogue scale (VAS) at 6 months after the baseline visit. The secondary outcomes were EQ VAS at 3 months, and EQ index, CIRP incidence and characteristics, and anxiety, depression, and PTSD at 3 and 6 months after baseline visits.
CONCLUSIONS: This program was not superior to standard care in improving QoL in critical COVID-19 survivors as measured by the EQ VAS. However, our data can help establish better strategies for the study and management of PICS and CIRP in this population.
TRIAL REGISTRATION: # NCT04394169, registered on 5/19/2020.
METHODS: The PAIN-COVID trial was a parallel-group, single-centre, single-blinded, randomized controlled trial. The intervention consisted of a follow up program, patient education on PICS and pain, and a psychological intervention based on Rehm's self-control model in patients with abnormal depression scores (≥8) in the Hospital Anxiety and Depression Scale (HADS) at the baseline visit. QoL was evaluated with the 5-level EQ 5D (EQ 5D 5 L), mood disorders with the HADS, post-traumatic stress disorder (PTSD) with the PCL-5 checklist, and pain with the Brief Pain Inventory short form, the Douleur Neuropathique 4 questionnaire, and the Pain Catastrophizing Scale. The primary outcome was to determine if the program was superior to standard-of-care on the EQ visual analogue scale (VAS) at 6 months after the baseline visit. The secondary outcomes were EQ VAS at 3 months, and EQ index, CIRP incidence and characteristics, and anxiety, depression, and PTSD at 3 and 6 months after baseline visits.
CONCLUSIONS: This program was not superior to standard care in improving QoL in critical COVID-19 survivors as measured by the EQ VAS. However, our data can help establish better strategies for the study and management of PICS and CIRP in this population.
TRIAL REGISTRATION: # NCT04394169, registered on 5/19/2020.