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Chronic PainPIPNCT07180407

The Post-ICU Pain Study

An observational study of Chronic Pain and Post Intensive Care Unit Syndrome, run by Zealand University Hospital at 4 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
800 participants
Where
4 sitesDenmark
Study dates
23 Sep 2025to Jun 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to the ICU

Who may be able to join

  • Adult ICU patients ≥18 years of age
  • Acute admission to the ICU
  • ICU length of stay of at least 48 hours

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bennedikte K Madsen, MD contact

0045

bkom@regionsjaelland.dk

Denmark4 sites, 4 recruiting

  • Aalborg University Hospital

    Aalborg, 9000

    Bodil S Rasmussen, Professor, MD, PhD, 0045, Bodil.steen.Rasmussen@rn.dk

    Not yet recruiting

  • Zealand University Hospital

    Køge, 4600

    Bennedikte Madsen, MD, 0045, bkom@regionsjaelland.dk

    bkom@regionsjaelland.dk

    Recruiting

  • Zealand University Hospital

    Nykøbing Falster, 4800

    Kim Rokamp, MD, 0045, kizr@regionsjaelland.dk

    Recruiting

  • Zealand University Hospital

    Roskilde, 4000

    Lone M Poulsen, MD, 0045, lmp@regionsjaelland.dk

    Recruiting

Other trials in Denmark

About this study

Official title: The Post-ICU Pain Study: a Multicenter, Prospective, Inception Cohort Study

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.

Read more

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.
Keywords
intensive care units, chronic pain, sleep disorder, anxiety and depression, icu survivors
Medical subject headings
Chronic Pain, Somatoform Disorders, Sleep Wake Disorders, Anxiety Disorders, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of pain

    Patients are defined as having pain if they answer "yes" to question number 1 in the Brief Pain Inventory - Short Form

    Measured: 180 day follow-up

Secondary outcomes (9)

  1. Brief Pain Inventory - Short Form (BPI-SF)

    Additional components of the Brief Pain Invenstory Short Form

    Measured: At follow-up at 90 and 180 days

  2. 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.

    Measured: at 90 and 180 days follow-up

  3. 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

    Measured: at 90 and 180 days

  4. 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

    Measured: at 90 and 180 days

  5. 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

    Measured: at 90 and 180 days

  6. 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

    Measured: 90 and 180 days

  7. 30-day mortality

    Measured: 30 days

  8. 90-day mortality

    Measured: 90 days

  9. 180 days mortality

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2025
  2. Study start23 Sep 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07180407
Sponsor's protocol ID
PIP-study
Acronym
PIP
Status last verified
Sep 2025
First submitted
15 Jul 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain and Post Intensive Care Unit Syndrome, run by Zealand University Hospital at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bennedikte K Madsen, MD (0045, bkom@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of pain (time frame: 180 day follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07180407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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The Post-ICU Pain Study (NCT07180407) | AzTrials