Anxiety Assessment Before Regional Anesthesia.

Anxiety Regional Anesthesia Pre-operative Clinical Trial

— Stress RA  

Official title:

Assessment of Anxiety Incidence Before Regional Anesthesia Achieving.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04199442
• Other study ID #: 00011
• Status: Terminated
• Start date: December 15, 2019
• Est. completion date: November 10, 2020

Study information

• Verified date: November 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: November 10, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Regional Anesthesia Pre-operative

Locations

Country	Name	City	State
Belgium	MontLegia Hospital	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. Erratum in: Br J Clin Psychol. 2020 Jun;59(2):276. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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