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Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04154410
Acronym
INNOVANX
Enrollment
71
Registered
2019-11-06
Start date
2022-06-30
Completion date
2022-12-30
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eligible for Day Case Surgery

Keywords

Pre-operative anxiety, pupillometry, heart rate variability, cardiac coherence state, ambulatory surgery

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.

Interventions

Non invasive finger tip monitoring before during and 5 minutes after cannulation

Portable videopupillometer to measure pupillary light reflex (PLR), variation coefficient of pupillary diameter (VCPD), pupillary diameter (PD) fluctuations before, during and 5 minutes after cannulation

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-Day case surgical patients

Exclusion criteria

* \<18yo * psychiatric disorders * participating refusal

Design outcomes

Primary

MeasureTime frameDescription
Analgesia Nociception Index (ANI)at Day 0Index 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

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGilles GUERRIER, MD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026