Hospitalized PatientPAINNNCT06980987
The PAINN Study - a Pilot Cross Sectional Study
An observational study of Hospitalized Patient and Home Mechanical Ventilation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Pain prevalence in hospitalized patients has been reported between 65% and 75%, indicating poor and/or insufficient management. In addition, pain prevalence has been estimated for separate groups of individuals with specific neurological/neurosurgical conditions (25% - 84%) and the overall prevalence was calculated as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospitalized Patient, Home Mechanical Ventilation, Pain
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2024to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital admitted patients, needing home mechanical ventilation for neurological disease or trauma,
Inclusion Criteria: persons hospital admitted, minimum 18 years old, provided informed consent (provided by the patient or patient's relative).
Exclusion Criteria: persons who did not understand written and spoken Danish or denied participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Prevalence and Management in Neurological and Neurosurgical in Patients- the PAINN Study
Pain prevalence in hospitalized patients has been reported between 65% and 75%, indicating poor and/or insufficient management. In addition, pain prevalence has been estimated for separate groups of individuals with specific neurological/neurosurgical conditions (25% - 84%) and the overall prevalence was calculated as 36% (95% CI: 31% - 42%). However, investigations on prevalence of pain in Danish neurologic inpatients is scarce, which may indicate an overlooked symptom in local neurologic settings.
This project was a cross-sectional investigation to identify pain prevalence, intensity and interference in admitted patients needing home menicahal ventilation (HMV) and we conducted as an exploratory investigation to collect data from the patients by pain questionnaires/instruments, observation of patients' pain behavior and physiologic parameters. The main patients' diagnoses were spinal cord injury, amyotrophic lateral sclerosis, cerebral palsy, spinal muscular atrophy, and defects from birth such as tracheomalacia. The study included 40 participants, all recruited from Respiratory Center East, University of Copenhagen, Rigshospitalet
- Keywords
- Pilot cross sectional study, Neurological patients, Home mechanical ventilation
- Medical subject headings
- Pain, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Pain impact on domains of every day life.
Measured: 24 hours
Secondary outcomes (3)
GAD-7
Anxiety/depression
Measured: 24 hours
PHQ-9
Anxiety/depression
Measured: 24 hours
The Barthel Index
Physical performance status
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start3 Jan 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Forsyth Herling, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980987
- Sponsor's protocol ID
- P-2023-98
- Other IDs
- Rigshospitalet
- Acronym
- PAINN
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is a quality assurance pilot project.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Prevalence and Management in Neurological and Neurosurgical in Patients- the PAINN Study
- ClinicalTrials.gov ID
- NCT06980987
- Acronym / sponsor ID
- PAINN / P-2023-98
- Keywords
- Pilot cross sectional study, Neurological patients, Home mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain prevalence in hospitalized patients has been reported between 65% and 75%, indicating poor and/or insufficient management. In addition, pain prevalence has been estimated for separate groups of individuals with specific neurological/neurosurgical conditions (25% - 84%) and the overall prevalence was calculated as 36% (95% CI: 31% - 42%). However, investigations on prevalence of pain in Danish neurologic inpatients is scarce, which may indicate an overlooked symptom in local neurologic settings.
This project was a cross-sectional investigation to identify pain prevalence, intensity and interference in admitted patients needing home menicahal ventilation (HMV) and we conducted as an exploratory investigation to collect data from the patients by pain questionnaires/instruments, observation of patients' pain behavior and physiologic parameters. The main patients' diagnoses were spinal cord injury, amyotrophic lateral sclerosis, cerebral palsy, spinal muscular atrophy, and defects from birth such as tracheomalacia. The study included 40 participants, all recruited from Respiratory Center East, University of Copenhagen, Rigshospitalet
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital admitted patients, needing home mechanical ventilation for neurological disease or trauma,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brief Pain Inventory
Time frame: 24 hours
Pain impact on domains of every day life.
3 secondary outcomes
GAD-7
Time frame: 24 hours
PHQ-9
Time frame: 24 hours
The Barthel Index
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No. It is a quality assurance pilot project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Patient and Home Mechanical Ventilation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.