Discomfort in Intensive Care Patients - IPREA-N

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06091046
• Other study ID #: 612620
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: Brita Fosser Olsen, Phd
• Phone: +47 99165586
• Email: brita.fosser.olsen[@]so-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Discomfort

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Ostfold Hospital Trust, Sykehuset Telemark, The Hospital of Vestfold, Vestre Viken Hospital Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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