BACKGROUND: ICU survivors may experience serious psychological, physical and cognitive impairments following ICU admission, collectively termed Post Intensive Care Syndrome (PICS). Persistent pain is an underrecognized component of PICS. Previous research has shown that persistent pain is a profound clinical challenge in ICU survivors, however, research demonstrates conflicting results. Furthermore, no studies have examined the prevalence of persistent pain in ICU survivors in a contemporary Danish ICU setting. OBJECTIVES: We aim to examine the clinical trajectory, risk factors, and pathophysiology of persistent pain in ICU survivors in Denmark. DESIGN AND SAMPLE SIZE: The study is designed as a multicenter, prospective, inception cohort study with clinical follow-up. Based on the pre-study sample size calculation, 800 patients will be included. Patients will be contacted by telephone 90 days and 180 days after ICU discharge, and a series of questionnaires regarding pain, sleep quality, affective state and quality of life will be completed. A subgroup of patients will undergo a detailed clinical examination including quantitative sensory testing between 180-365 days after ICU discharge. POPULATION: Patients will be recruited from 4 Danish ICU departments. Inclusion criteria include adult patients (18 years of age), acute admission to the ICU, and an ICU admission of a minimum of 48 hours. OUTCOMES: The primary outcome is the prevalence of pain assessed by the Brief Pain Inventory (BPI) at 90 and 180 days after ICU discharge. Secondary outcomes include additional detailed descriptions of pain and daily activity, sleep quality, affective state, quality of life, treatment- and patient-related risk factors, and biomarkers associated with development of persistent pain. Substudies: \- QST substudy: 80 participants (40 with pain and 40 without pain) recruited from the main cohort will undergo Quantative Somatosensory Testing (QST). The objectives are first, to delineate somatosensory profiles of ICU survivors with and without pain, and second, to examine the presence of neuropathic pain in ICU survivors.
Study Type
OBSERVATIONAL
Enrollment
800
Aalborg University Hospital
Aalborg, Denmark
NOT_YET_RECRUITINGZealand University Hospital
Køge, Denmark
RECRUITINGZealand University Hospital
Nykøbing Falster, Denmark
RECRUITINGZealand University Hospital
Roskilde, Denmark
RECRUITINGPrevalence of pain
Patients are defined as having pain if they answer "yes" to question number 1 in the Brief Pain Inventory - Short Form
Time frame: 180 day follow-up
Brief Pain Inventory - Short Form (BPI-SF)
Additional components of the Brief Pain Invenstory Short Form
Time frame: At follow-up at 90 and 180 days
Incidence of new-onset persistent pain after ICU discharge
Definition of new-onset persistent pain: Individuals presenting with pain according to Brief Pain Inventory Short Form at 90 AND 180 days follow-up AND not suffering from persistent pain/using pain medication regularly before ICU admission, as reported by the individual.
Time frame: at 90 and 180 days follow-up
Quality of life measured by EuroQol-5-domain 5-level (EQ-5D-5L)
The EQ-5D-5L comprises 5 components (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) which can be rated at 5 levels. Furthermore, a Visual Analog Scale (VAS) documents self-rated health
Time frame: at 90 and 180 days
The Single Item Sleep Quality Scale (SQS)
The respondent is asked to rate the overall quality of sleep over a 7-day recall period on a VAS. Respondents are instructed to consider the following components before answering the questionnaire: hours of sleep, night wakings, how easily they fall asleep, how often they wake earlier then needed, and how refreshed they feel when waking. Sleep quality is scored as follows: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent
Time frame: at 90 and 180 days
Hospital Anxiety and Depression Scale (HADS)
It comprises seven questions regarding anxiety and seven questions regarding depressive symptoms. Anxiety and depression are scored separately with recommended cut-off values of 8-10 for possible presence of a mood disorder and \>11 for probable presence of a mood disorder
Time frame: at 90 and 180 days
Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Only patients answering "yes" to the Brief Pain Inventory Short Form, question number 1, will be asked to fill out the S-LANSS. The tool was created as a clinical tool to identify pain primarily of neuropathic origin, allowing for the differentiation between neuropathic pain and nociceptive pain. It contains 7 items assessing pain quality, sensory changes and specific symptoms commonly associated with neuropathic pain. A score above 12 suggests neuropathic pain
Time frame: 90 and 180 days
30-day mortality
Time frame: 30 days
90-day mortality
Time frame: 90 days
180 days mortality
Time frame: 180 days
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