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Anxiety Assessment Before Regional Anesthesia. (Stress RA)

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ClinicalTrials.gov Identifier: NCT04199442
Recruitment Status : Terminated (Sanitary crisis du to Covid-19)
First Posted : December 16, 2019
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Pierre Goffin, University of Liege

Brief Summary:
We want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.

Condition or disease
Anxiety Regional Anesthesia Pre-operative

Detailed Description:
When patients arrive in the operating room, we want to submit them a validated questionnaire (APAIS score and STAI-6 score) to assess their anxiety. After that, the care (anesthesia and surgeries) will take place in a very usual way and similar to our standards of care.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Anxiety Incidence Before Regional Anesthesia Achieving.
Actual Study Start Date : December 15, 2019
Actual Primary Completion Date : January 2, 2020
Actual Study Completion Date : November 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. APAIS score [ Time Frame: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made ]
    anxiety measurement score

  2. STAI-6 score [ Time Frame: Achievement of the score on arrival at the operating area (between 15-30 minutes before to realise the regional anesthesia block). Only one determination of the score is made ]
    anxiety measurement score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who come to the operating room for surgery under regional anesthesia.
Criteria

Inclusion Criteria:

  • patient> 18 years
  • surgery performed under general anesthesia or not but preceded by a regional anesthesia.

Exclusion Criteria:

  • refusal of the patient
  • psychiatric disorders (pathological anxiety, psychosis, depression)
  • language barrier
  • major drug impregnation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199442


Locations
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Belgium
MontLegia Hospital
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Pierre Goffin MontLegia Hospital, Groupe Santé CHC
Publications:
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Responsible Party: Pierre Goffin, Principal Investigator, University of Liege
ClinicalTrials.gov Identifier: NCT04199442    
Other Study ID Numbers: 00011
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders