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CompletedNCT06980987PAINNUpdated May 20, 2025

The PAINN Study - a Pilot Cross Sectional Study

An observational study in Hospitalized Patient, Home Mechanical Ventilation and Pain, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Sex
All
01

Study 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 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

02

Conditions studied

  • Hospitalized Patient
  • Home Mechanical Ventilation
  • Pain
  • Pain Management

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Keywords

  • Pilot cross sectional study
  • Neurological patients
  • Home mechanical ventilation
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 301 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospital admitted patients, needing home mechanical ventilation for neurological disease or trauma,

Eligibility criteria

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.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Brief Pain Inventory

    Pain impact on domains of every day life.

    Time frame: 24 hours

Secondary outcomes

  1. GAD-7

    Anxiety/depression

    Time frame: 24 hours

  2. PHQ-9

    Anxiety/depression

    Time frame: 24 hours

  3. The Barthel Index

    Physical performance status

    Time frame: 24 hours

07

Study locations

1 site
  • Respirations center east
    Copenhagen, Ø 2100, Denmark
08

References and documents

Individual participant data

Plan to share: No — It is a quality assurance pilot project.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06980987
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Suzanne Forsyth Herling (Associate professor, RN, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
May 20, 2025
Start date
Jan 3, 2024
Primary completion
May 1, 2024
Completion
May 1, 2024
Last update
May 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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