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

NCT ID: NCT03983590

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-02
• Study Completion Date: 2019-11-27

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.

Conditions

Pain; Anxiety; Palliative Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Visual Analogic Scale

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• admitted in palliative care

-≥18 years old

• enough communication abilities to use VAS
• non opposition of the patient

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume ROBERT, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Centre Hospitalier Universitaire de Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC18_3054_ADA-PALLIA

Identifier Type: -

Identifier Source: org_study_id