Anxiety, Pain et Analgesia Nociception Index (ANI) in Palliative Care (ADA-Pallia)

Rennes University Hospital

Status: Completed

Conditions: Anxiety; Pain; Palliative Care

Treatments: Other: Visual Analogic Scale

Study type: Observational

Funder types: Other

Identifiers

NCT03983590

35RC18_3054_ADA-PALLIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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