The PAINN Study - a Pilot Cross Sectional Study

NCT06980987 | Completed

• 2 other identifiers: P-2023-98Rigshospitalet
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hospitalized Patient; Home Mechanical Ventilation; Pain; Pain Management

Keywords

Pilot cross sectional study; Neurological patients; Home mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory

  Pain impact on domains of every day life.

  24 hours

Secondary Outcomes (3)

• GAD-7

  24 hours

• PHQ-9

  24 hours

• The Barthel Index

  24 hours

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Respirations center east

Copenhagen, Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, RN

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: January 3, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)