Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT05176457
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Communication Tool Evaluation on Intensive Care Patients.
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICT'REA
Brief Summary:
The present study evaluate the impact of a communication tool "PICT'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking.
The app consists of simple pictograms allowing simple communication between patients and the reanimation care team.
The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.
The app consists of simple pictograms allowing simple communication between patients and the reanimation care team.
The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.
Detailed Description:
Invasive mechanical ventilation is commonly used in intensive care, in sedated patients but also in perfectly conscious patients, and this on a daily basis.
For these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.
Thus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.
PICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).
The study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:
* Before setting up the tool: control group
* Over a period of 6 months
* In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.
* After setting up the tool:
* Over a period of 6 months
* In the same departments.
The analyses consists of various questionnaires :
* the modified Ease of Communication Scale,
* a Short questionnaire in 3 questions for caregivers,
* IPREA questionnaire for patients,
* Evaluation of the usability of the system by System Usability Scale questionnaire,
* Evaluation of the attractiveness of the system by Attrackdiff questionnaire.
For these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.
Thus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.
PICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).
The study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:
* Before setting up the tool: control group
* Over a period of 6 months
* In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.
* After setting up the tool:
* Over a period of 6 months
* In the same departments.
The analyses consists of various questionnaires :
* the modified Ease of Communication Scale,
* a Short questionnaire in 3 questions for caregivers,
* IPREA questionnaire for patients,
* Evaluation of the usability of the system by System Usability Scale questionnaire,
* Evaluation of the attractiveness of the system by Attrackdiff questionnaire.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: