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Discomfort in Intensive Care Patients - IPREA-N

Sponsor
Oslo University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06091046
Collaborator
Vestre Viken Hospital Trust (Other), The Hospital of Vestfold (Other), Ostfold Hospital Trust (Other), Sykehuset Telemark (Other)
250
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Assessment of Discomfort in Intensive Care Patients and Psychometric Testing of the Applied Questionnaire IPREA-N
    Anticipated Study Start Date :
    Aug 1, 2024
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Sep 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Discomfort measured by IPREA-N questionnaire [Within 24 hours following Intensive care unit stay]

      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,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Helene Berntzen, Phd, Oslo University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helene Berntzen, RN, CCN, Phd, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT06091046
    Other Study ID Numbers:
    • 612620
    First Posted:
    Oct 19, 2023
    Last Update Posted:
    Oct 19, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Oct 19, 2023