NCT04154410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
2.6 years until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 6, 2026

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 23, 2019

Last Update Submit

March 4, 2026

Conditions

Eligible for Day Case Surgery

Keywords

Pre-operative anxietypupillometryheart rate variabilitycardiac coherence stateambulatory surgery

Outcome Measures

Primary Outcomes (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

    at Day 0

Secondary Outcomes (5)

  • Coefficient of variation of pupillary diameter (CVDP)

    at Day 0

  • Visual Analog Scale (VAS)

    at Day 0

  • Heart rate variability

    at Day 0

  • Analgesia Nociception Index (ANI)

    at Day 0 - after 30 minutes immersive light intervention

  • Visual Analog Scale (VAS)

    at Day 0 - after 30 minutes immersive light intervention

Interventions

algiscanOTHER

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

Also known as: Pupillometric measures
Analgesia Nociception IndexOTHER

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

Also known as: Heart rate variability measures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective patients for day-case surgical procedure

You may qualify if:

  • Day case surgical patients

You may not qualify if:

  • \<18yo
  • psychiatric disorders
  • participating refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital, APHP

Paris, France, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 38239470RESULT

Study Officials

  • Gilles GUERRIER, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

November 6, 2019

Study Start

June 30, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

March 6, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)