Clinical trial NCT04154410: Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry
Official title: Prospective Observational Study of the Non Invasive Objective Assessment of Pre-operative Anxiety Using the Heart Rate Variability and the Pupillary Reflex Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eligible for Day Case Surgery
Keywords: Pre-operative anxiety
pupillometry
heart rate variability
cardiac coherence state
ambulatory surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective patients for day-case surgical procedure

Brief summary: The purpose of this study is to determine whether heart rate variability levels and pupillometric measures are effective objective predictors of anxiety among patients before surgery.

Detailed description: The prevalence of preoperative anxiety in adults is estimated between 60 and 80% and prevents a good integration of the information delivered, while seeking more attention from caregivers. In addition, anxious patients require the administration of higher doses of hypnotics at anesthetic induction. The pain expressed in the postoperative period is proportional to preoperative anxiety, with a slower recovery kinetics responsible for prolonged stay in the recovery room. Finally, the incidence of chronic pain is correlated with the intensity of preoperative anxiety.

While the recommendations of the European Anesthesia Society (ESA) emphasize the importance of managing preoperative anxiety, this dimension is often overlooked and existing methods of assessment are time consuming and sometime inaccurate.

Objective screening with dynamic monitoring of the level of anxiety in real time is the necessary step to ensure accurate detection and personalized management of the emotional state of patients before performing an invasive procedure.

Anxiety is an emotional state reflecting an imbalance of cortico-frontal regulation on the limbic system. The interaction between these two neuronal systems is expressed in particular by the intensity of the vagal tone and the autonomic nervous system. Exploring the balance between sympathetic and parasympathetic systems is a promising avenue of exploration for identifying, predicting, and treating anxiety.

Two reliable and easy-to-use devices analyzing the expression of the autonomic nervous system validated in the analysis of nociception in the awake patient or under general anesthesia are marketed:

A. Analgesia Nociception Index (ANI) (MDoloris Medical Systems) analyzing oscillatory changes in heart rate as a function of respiratory time, namely the heart rate variability (HRV) B. Algiscan (IDMed) analyzing pupil responsiveness to nociception

The use of these devices in conscious pre-operative patients could allow a reliable and objective detection of anxiety while following its kinetic evolution over time. The purpose of this project is to evaluate the validity of these two devices in the context of preoperative anxiety. After receiving clear information and giving their written agreement, patients will be included in the study by the anesthetist physician. During the anesthesia consultation, the included patients will be subjected to a Surgical Fear Questionnaire (SFQ) questionnaire of level of anxiety.

A secondary study will consist of connecting a lighting device connected to the heart rate variability to emit a relaxing light in the preoperative waiting room.

Eligibility criteria: Inclusion Criteria:

-Day case surgical patients

Exclusion Criteria:

* \<18yo
* psychiatric disorders
* participating refusal

Primary outcomes:
measure: Analgesia Nociception Index (ANI)
timeFrame: at Day 0
Secondary outcomes:
measure: Coefficient of variation of pupillary diameter (CVDP)
timeFrame: at Day 0
measure: Visual Analog Scale (VAS)
timeFrame: at Day 0
measure: Heart rate variability
timeFrame: at Day 0
measure: Analgesia Nociception Index (ANI)
timeFrame: at Day 0 - after 30 minutes immersive light intervention
measure: Visual Analog Scale (VAS)
timeFrame: at Day 0 - after 30 minutes immersive light intervention
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital, APHP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gilles GUERRIER, MD
role: PRINCIPAL_INVESTIGATOR
References: