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Eligible for Day Case SurgeryINNOVANXNCT04154410

Prediction of Pre-operative Anxiety by Heart Variability and Pupillometry

An observational study of Eligible for Day Case Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eligible for Day Case Surgery
What is being tested?
Analgesia Nociception Index and algiscan
How many people
71 participants
Where
1 siteFrance
Study dates
30 Jun 2022to 30 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Elective patients for day-case surgical procedure

Who may be able to join

  • -Day case surgical patients

Who cannot join

  • <18yo
  • psychiatric disorders
  • participating refusal

Trial locations and contacts

1 site in 1 country.

France1 site
  • Cochin Hospital, APHP

    Paris, France, 75014

Other trials in France

About this study

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

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.

Read the 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:

  1. 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.

Being tested
Analgesia Nociception Index, algiscan
Keywords
Pre-operative anxiety, pupillometry, heart rate variability, cardiac coherence state, ambulatory surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Analgesia Nociception IndexOther

    Also called Heart rate variability measures

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

  • algiscanOther

    Also called Pupillometric measures

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at Day 0

Secondary outcomes (5)
  1. 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

    Measured: at Day 0

  2. Visual Analog Scale (VAS)

    Measure of anxiety reduction 30 minutes after the beginnig of the luminous immersion

    Measured: at Day 0

  3. Heart rate variability

    comparison between anxious and non-anxious patients Variation 5 minutes before during and 5 minutes after cannulation

    Measured: at Day 0

  4. Analgesia Nociception Index (ANI)

    Impact of 30 minutes immersive light intervention on measures of ANI and VAE

    Measured: at Day 0 - after 30 minutes immersive light intervention

  5. Visual Analog Scale (VAS)

    Impact of 30 minutes immersive light intervention on measures of ANI and VAS

    Measured: at Day 0 - after 30 minutes immersive light intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start30 Jun 2022
  3. Primary completion30 Nov 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04154410
Sponsor's protocol ID
APHP190697
Other IDs
2019-A01743-54
Acronym
INNOVANX
Status last verified
Sep 2025
First submitted
23 Sep 2019
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 38239470

Questions about this trial

What is this clinical trial studying?

An observational study of Eligible for Day Case Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analgesia Nociception Index (ANI) (time frame: at Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04154410, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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