Critical IllnessNCT06091046
Discomfort in Intensive Care Patients - IPREA-N
An observational study of Critical Illness and Discomfort, run by Oslo University Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Discomfort
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who move to another hospital and cannot complete the questionnaire within 24 hours due to health status or practical reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Critical Illness, Discomfort
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: Within 24 hours following Intensive care unit stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study startAug 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, The Hospital of Vestfold, Ostfold Hospital Trust, Sykehuset Telemark
- Responsible party
- Principal investigator, Helene Berntzen, Oslo University Hospital
- Investigators
- Helene Berntzen, Phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091046
- Sponsor's protocol ID
- 612620
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Discomfort in Intensive Care Patients and Psychometric Testing of the Applied Questionnaire IPREA-N
- ClinicalTrials.gov ID
- NCT06091046
- Acronym / sponsor ID
- 612620
- Conditions
- Critical Illness, Discomfort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Vestre Viken Hospital Trust, The Hospital of Vestfold, Ostfold Hospital Trust, Sykehuset Telemark
- Study start
- Aug 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who move to another hospital and cannot complete the questionnaire within 24 hours due to health status or practical reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discomfort measured by IPREA-N questionnaire
Time frame: 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,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Berntzen, Phd principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Discomfort, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brita Fosser Olsen, Phd (+47 99165586, brita.fosser.olsen@so-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort measured by IPREA-N questionnaire (time frame: Within 24 hours following Intensive care unit stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.