Discomfort in Intensive Care Patients - IPREA-N

NCT06091046 | Unknown

• 1 other identifier: 612620
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate discomforts experienced by intensive care patients during their critical illness period. We will use the Norwegian version of the questionnaire Inconforts des Patients de REAnimation (IPREA), the IPREA-N.Patients will be asked to rate18 questions about different possible discomforts on a 0-10 scale after their intensive care stay. Furthermore we aim to test whether the questionnaire when translated into Norwegian is useful in the Norwegian patient population. The aim of the study is

• to assess perceived discomfort in intensive care patients using the IPREA-N questionnaire
• to test psychometric properties of the questionnaire

Conditions

Critical Illness; Discomfort

Outcome Measures

Primary Outcomes (1)

• Discomfort measured by IPREA-N questionnaire

  IPREA-N consists of 18 Questions about discomfort during intensive care stay, answered on a 0-10 scale. Questions cover discomforts caused by noise, too much light, uncomfortable bed, lack of sleep, thirst, hunger, feeling cold, feeling hot, pain, medical devices, embarrassment, anxiety or panic, isolation, visiting hours restriction, lack of telephone, lack of information, difficulty breathing and feelings of depression,

  Within 24 hours following Intensive care unit stay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care units at five different hospitals in the South-East Norway will participate in the study. Each hospital will include approximately 50 patients.

You may qualify if:

• Adult intensive care patients (\> 18 years),
• Understanding Norwegian
• Having spent more than 48 hours in the intensive care unit.
• Ability to consent to participation and self-report discomfort

You may not qualify if:

• Patients who move to another hospital and cannot complete the questionnaire within 24 hours due to health status or practical reasons.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Vestre Viken Hospital Trust: collaborator
• The Hospital of Vestfold: collaborator
• Ostfold Hospital Trust: collaborator
• Sykehuset Telemark: collaborator

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helene Berntzen, Phd

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brita Fosser Olsen, Phd

CONTACT

+47 99165586; brita.fosser.olsen@so-hf.no

Edda Johansen, Phd

CONTACT

+47 41642376; edda.johansen@usn.no

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, CCN, Phd

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10