Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry (INNOVANX)

Prospective Observational Study of the Non Invasive Objective Assessment of Pre-operative Anxiety Using the Heart Rate Variability and the Pupillary Reflex Measurement

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.

Study Overview

• Status: Completed
• Conditions: Eligible for Day Case Surgery
• Intervention / Treatment: Other: Analgesia Nociception Index; Other: algiscan

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.

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • France
    • Paris, France, France, 75014
      • Cochin Hospital, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Elective patients for day-case surgical procedure

Description

Inclusion Criteria:

-Day case surgical patients

Exclusion Criteria:

• <18yo
• psychiatric disorders
• participating refusal

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia Nociception Index (ANI)	Index from 0 to 100 Variation 5 minutes before during and 5 minutes after cannulation Comparison between anxious and non-anxious patients Measure of anxiety reduction	at Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coefficient of variation of pupillary diameter (CVDP)	Percentage from 0 to 100% Variation 5 minutes before during and 5 minutes after cannulation Comparison between anxious and non-anxious patients	at Day 0
Visual Analog Scale (VAS)	Measure of anxiety reduction 30 minutes after the beginnig of the luminous immersion	at Day 0
Heart rate variability	comparison between anxious and non-anxious patients Variation 5 minutes before during and 5 minutes after cannulation	at Day 0
Analgesia Nociception Index (ANI)	Impact of 30 minutes immersive light intervention on measures of ANI and VAE	at Day 0 - after 30 minutes immersive light intervention
Visual Analog Scale (VAS)	Impact of 30 minutes immersive light intervention on measures of ANI and VAS	at Day 0 - after 30 minutes immersive light intervention

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Gilles GUERRIER, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Richez J, Rothschild PR, Baillard C, Guerrier G. Investigating pupillometry to detect preoperative anxiety: a pilot study. Front Psychol. 2024 Jan 3;14:1296387. doi: 10.3389/fpsyg.2023.1296387. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: heart rate variability; pupillometry; ambulatory surgery; Pre-operative anxiety; cardiac coherence state
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: APHP190697; 2019-A01743-54 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No