Clinical trial NCT03983590: Anxiety, Pain et Analgesia Nociception Index (ANI) in Palliative Care
Official title: Analgesia Nociception Index (ANI) for Pain and Anxiety Assessment in Palliative Care : a Pilot Study in University Hospital of Rennes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Anxiety
Palliative Care
Keywords: pain
anxiety
communicative
palliative care
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have just been admitted in palliative care unit and who have communication abilities enough for pain and anxiety self-assessment.

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 and/or anxiety is the first bed bath after admission. The secondary objectives aim to identify ANI score thresholds which would be predictive of pain and/or 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 patient's chest, it measures the balance between sympathetic/parasympathetic 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.

Eligibility criteria: Inclusion Criteria:

* admitted in palliative care

  -≥18 years old
* enough communication abilities to use VAS
* non opposition of the patient

Non-inclusion criteria :

* previous bed bath already provided to the patient in the palliative unit (anxiolytic and analgesic strategies already adapted limiting the risk of pain or anxiety and the power of the study )
* adult under legal protection (guardianship, trusteeship ...)
* contraindication of ANI : respiratory rate \< 10/min, non sinusal cardiac rythm, cardiotropic treatments
* behavioural disorders : agitation, confusion (Richmond scale score \> ou = 1)
* alertness disorders : somnolence (Richmond scale score \< ou = -1)
* no French speaking

Exclusion criteria:

* providing the bad bath is impossible
* secondary opposition of the patient

Primary outcomes:
measure: correlation rate of ANI (Analgesia Nociception Index) scores and pain Visual Analogic Scale (VAS) scores at each measurement time.
timeFrame: VAS are collected in the first 24 hours after inclusion, 15 minutes, during and 15 minutes after the bed bath. Each time of collection are noted.
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Guillaume ROBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: