Chronic Pain, Pain Disorder, Post Intensive Care Unit Syndrome, Quality of Life
Conditions
Keywords
intensive care units, chronic pain, sleep disorder, anxiety and depression, icu survivors
Brief summary
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.
Interventions
None listed
Sponsors
Aalborg University Hospital
Zealand University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult ICU patients ≥18 years of age * Acute admission to the ICU * ICU length of stay of at least 48 hours
Exclusion criteria
* Patients transferred from a non-participating ICU * Patients with pre-planned admission to the ICU e.g., following elective surgery * Patients unable to complete questionnaires, including those who are unable to understand or speak Danish, or patients with severe cognitive deficits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of pain | 180 day follow-up | Patients are defined as having pain if they answer yes to question number 1 in the Brief Pain Inventory - Short Form |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Single Item Sleep Quality Scale (SQS) | at 90 and 180 days | 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 |
| 30-day mortality | 30 days | — |
| 90-day mortality | 90 days | — |
| 180 days mortality | 180 days | — |
| Brief Pain Inventory - Short Form (BPI-SF) | At follow-up at 90 and 180 days | Additional components of the Brief Pain Invenstory Short Form |
| Incidence of new-onset persistent pain after ICU discharge | at 90 and 180 days follow-up | 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. |
| Quality of life measured by EuroQol-5-domain 5-level (EQ-5D-5L) | at 90 and 180 days | 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 |
| Hospital Anxiety and Depression Scale (HADS) | at 90 and 180 days | 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 |
| Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) | 90 and 180 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| QST outcomes | between 180 days followup and 360 days | QST SUBSTUDY: \- simple reaction time (seconds) |
| PainDETECT (PD-Q) | between 180 days followup and 360 days | QST SUBSTUDY: The questionnaire assesses pain intensity (three questions), pain course patterns, the location of pain and presence of radiating pain (via a body chart), and sensory descriptors of pain (seven questions). Scores of 0-12 indicate neuropathic pain component is unlikely, scores of 12-18 indicates results are ambiguous, however a neuropathic component can pe present, and lastly scores of 19-38 indicates neuropathic pain component is likely |
| The Short Physical Performance Battery (SPPB) | between 180 days followup and 360 days. | QST SUBSTUDY: This test includes a series of tasks designed to examine physical performance. The SPPB requires limited space and takes about 10 minutes to complete. It contains 3 domains (3 m gait speed, 5 times chair stands, and 3 progressive standing balance tasks). Each component is scored separately, and a total score is calculated. The maximum score is 12 indicating little to no mobility impairment |
Countries
Denmark
Contacts
Primary ContactBennedikte K Madsen, MD
Outcome results
None listed