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.
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.
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:
- 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.
- Conditions
- Eligible for Day Case Surgery
- 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.
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)
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
Visual Analog Scale (VAS)
Measure of anxiety reduction 30 minutes after the beginnig of the luminous immersion
Measured: at Day 0
Heart rate variability
comparison between anxious and non-anxious patients Variation 5 minutes before during and 5 minutes after cannulation
Measured: at Day 0
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
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.
- First posted6 Nov 2019
- Study start30 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eligible for Day Case SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Gilles GUERRIER, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04154410
- Acronym / sponsor ID
- INNOVANX / APHP190697
- Conditions
- Eligible for Day Case Surgery
- Keywords
- Pre-operative anxiety, pupillometry, heart rate variability, cardiac coherence state, ambulatory surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective patients for day-case surgical procedure
Key inclusion criteria (1 listed)
- -Day case surgical patients
Key exclusion criteria (3 listed)
- <18yo
- psychiatric disorders
- participating refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesia Nociception IndexAlso: Heart rate variability measuresNon invasive finger tip monitoring before during and 5 minutes after cannulation | Other | – |
| algiscanAlso: Pupillometric measuresPortable videopupillometer to measure pupillary light reflex (PLR), variation coefficient of pupillary diameter (VCPD), pupillary diameter (PD) fluctuations before, during and 5 minutes after cannulation | Other | – |
Primary outcome
Analgesia Nociception Index (ANI)
Time frame: at Day 0
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
5 secondary outcomes
Coefficient of variation of pupillary diameter (CVDP)
Time frame: at Day 0
Visual Analog Scale (VAS)
Time frame: at Day 0
Heart rate variability
Time frame: at Day 0
Analgesia Nociception Index (ANI)
Time frame: at Day 0 - after 30 minutes immersive light intervention
Visual Analog Scale (VAS)
Time frame: at Day 0 - after 30 minutes immersive light intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication: PubMed 38239470Richez 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles GUERRIER, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.