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NCT04209517 Clinical Trial

Behavioral Markers of Pre-operative Anxiety

Preoperative Anxiety Clinical Trial

— KINESIS  

Official title:
Behavioral Markers of Pre-operative Anxiety : a Prospective Observational Study in Ambulatory Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04209517
Other study ID # APHP191092
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date August 1, 2022

Study information
Verified date November 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Gilles GUERRIER, MD
Phone (33) 158414813
Email gilles.guerrier@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patients scheduled for elective ambulatory surgery Exclusion Criteria: - communication difficulties

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Filming
Behavioural markers selection from video-recordings of the interview

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between behaviour and anxiety Correlation between behavioural markers and declarative anxiety 1 day
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