Discomfort in Intensive Care Patients - IPREA-N | NCT06091046

Studies
Discomfort in Intensive Care Patients - IPREA-N

NCT06091046

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Oct 30, 2023Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Critical Illness
Discomfort

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2024Estimated

Primary Completion Date

Sep 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Oct 13, 2023

First Submission Date that Met QC Criteria

Oct 13, 2023

First Posted Date

Oct 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2023

Last Update Posted Date

Oct 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helene Berntzen, RN, CCN, Phd, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
Vestre Viken Hospital Trust	OTHER
The Hospital of Vestfold	OTHER
Ostfold Hospital Trust	OTHER
Sykehuset Telemark

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brita Fosser Olsen, Phd	Contact	+47 99165586		brita.fosser.olsen@so-hf.no
Edda Johansen, Phd	Contact	+47 41642376		edda.johansen@usn.no

Overall Officials

Name	Affiliation	Role
Helene Berntzen, Phd	Oslo University Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided