The PAINN Study - a Pilot Cross Sectional Study

Completed

• Conditions: Hospitalized Patient; Home Mechanical Ventilation; Pain; Pain Management

• Registration Number: NCT06980987
• Lead Sponsor: Rigshospitalet, Denmark

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-03
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory	24 hours	Pain impact on domains of every day life.

Secondary Outcome Measures

Name	Time	Method
GAD-7	24 hours	Anxiety/depression
PHQ-9	24 hours	Anxiety/depression
The Barthel Index	24 hours	Physical performance status

Trial Locations

Locations (1)

Respirations center east; 🇩🇰 Copenhagen, Denmark