Anxiety Assessment Before Regional Anesthesia. (Stress RA)

Assessment of Anxiety Incidence Before Regional Anesthesia Achieving.

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

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • MontLegia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who come to the operating room for surgery under regional anesthesia.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APAIS score	anxiety measurement score	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
STAI-6 score	anxiety measurement score	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

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Pierre Goffin, MontLegia Hospital, Groupe Santé CHC

Publications and helpful links

General Publications

• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276.
• Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Actual): January 2, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 00011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No