Discomfort in Intensive Care Patients - IPREA-N

Assessment of Discomfort in Intensive Care Patients and Psychometric Testing of the Applied Questionnaire IPREA-N

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

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Discomfort

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Brita Fosser Olsen, Phd; Phone Number: +47 99165586; Email: brita.fosser.olsen@so-hf.no
• Study Contact Backup: Name: Edda Johansen, Phd; Phone Number: +47 41642376; Email: edda.johansen@usn.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Vestre Viken Hospital Trust; Ostfold Hospital Trust; The Hospital of Vestfold; Sykehuset Telemark
• Investigators: Principal Investigator: Helene Berntzen, Phd, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 612620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No