Behavioral Markers of Pre-operative Anxiety | NCT04209517

Studies
Behavioral Markers of Pre-operative Anxiety

NCT04209517

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Last Update Posted

Mar 16, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Preoperative Anxiety

Interventions

Filming

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Abandonment of the study project

Expanded Access Info

Start Date

Aug 2022Estimated

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Aug 1, 2022Estimated

First Submitted Date

Dec 20, 2019

First Submission Date that Met QC Criteria

Dec 23, 2019

First Posted Date

Dec 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2026

Last Update Posted Date

Mar 16, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to identify the characteristics of patients' behavioural patterns related to declared anxiety levels in a day-care surgical unit using ethological analysis of video-recordings of the pre-operative interview with the nurse.

Detailed Description

Guidelines in anaesthesia recommend systematic preoperative anxiety management to prevent negative perioperative impact, including impaired memory of important instructions and high incidence of post-operative acute and chronic pain. Self-administered questionnaires linked to scales to assess anxiety in the preoperative setting are usual practice. Yet, they are time consuming and rely on patient willingness to comply with instructions, which is not always reliable. The effects of acute anxiety on behaviour are poorly explored in the preoperative context. Quantifying and characterizing behavioural patterns in anxious patients using an applied ethological approach may provide useful information for reliable, accurate and objective assessment before surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Filming	Other	Behavioural markers selection from video-recordings of the interview

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between behaviour and anxiety	Correlation between behavioural markers and declarative anxiety	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients scheduled for elective ambulatory surgery

Exclusion Criteria:

communication difficulties

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients scheduled for elective ambulatory surgery

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided