Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06091046
Other study ID # 612620
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness