Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03983590
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2019-06-06
Brief Title:
Anxiety Pain et Analgesia Nociception Index ANI in Palliative Care
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Analgesia Nociception Index ANI for Pain and Anxiety Assessment in Palliative Care a Pilot Study in University Hospital of Rennes
Status:
COMPLETED
Status Verified Date:
2022-04
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:
ADA-Pallia
Brief Summary:
The main objective of this study is to evaluate the correlation between ANI and pain scores and the correlation of ANI and anxiety scores in communicative patients in palliative care
The chosen event with a risk of pain andor anxiety is the first bed bath after admission The secondary objectives aim to identify ANI score thresholds which would be predictive of pain andor anxiety and to figure out some individual factors influencing ANI scores
The chosen event with a risk of pain andor anxiety is the first bed bath after admission The secondary objectives aim to identify ANI score thresholds which would be predictive of pain andor anxiety and to figure out some individual factors influencing ANI scores
Detailed Description:
Pain and anxiety assessments are still challenges for palliative care teams Anxiolytics and painkillers are the usual tools but sometimes the symptoms and so the drugs to deliver are difficult to distinguish For patients with maintained communication abilities pain self-assessment using Visual Analogic Scores are the gold standard Could pain assessment be optimised thanks to ANI ANI is used in anaesthesiology and intensive care The ANI system is based on the analysis of intra-cardiac variability Based as an electrocardiograph with two electrodes on the patients chest it measures the balance between sympatheticparasympathetic tones leading to a pain score This score is predictive of pain occurrence leading to an early analgesic treatment and a better control of pain with less quantity of drugs However some studies reported that anxiety and emotions could influence ANI pain score
To test this hypothesis in palliative care field this study compares pain and anxiety VAS to ANI scores before during and after the bed bath
To test this hypothesis in palliative care field this study compares pain and anxiety VAS to ANI scores before during and after the bed bath
Study Oversight
Has Oversight DMC:
None
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?:
None