Level of Anxiety in Patients Undergoing Invasive Foot Surgery

Surgery Clinical Trial

Official title:

Preoperative Anxiety Level and Associated Factors in Patients Undergoing Minimally Invasive Osteoarticular Foot Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948748
• Other study ID #: 08/07/2023
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Universidad Católica de Ávila
• Contact: Jorge V Velázquez Saornil, PhD.
• Phone: +34920251020
• Email: jorge.velazquezsaornil[@]ucavila.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Preoperative anxiety has been studied in different medical disciplines, but it is unknown in minor surgical procedures such as foot nail surgery. This study aimed to determine the prevalence of preoperative anxiety and postoperative pain in foot nail surgery. The validated Amsterdam preoperative anxiety and information scale (APAIS) was used to evaluate preoperative anxiety and the need for information in 155 patients undergoing foot nail surgery. In addition, a questionnaire was used to collect other variables such as age, sex and educational level. The verbal numeric scale was employed to value the postoperative pain after 24 h.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: January 1, 2024
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• be over18 years old.
• ASA I and II (American Society of Anesthesiologists).
• autonomous capacity to fill out the surveys and participate in the study

Exclusion Criteria:

• mental and/or emotional disorders.
• incapacity to understand.
• people medicated with anxiolytics before the surgery.
• chronic pain in the foot and/or analgesic treatment for chronic pain.
• did not fulfill the postoperative recommendations.
• contraindication to the study's medical guideline.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Postoperative
• Surgery

Intervention

Procedure:
• foot surgery
minimally invasive osteoarticular foot surgery

Locations

Country	Name	City	State
Spain	Jorge V Velázquez Saornil	Ávila	Avila

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica de Ávila

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Aust H, Eberhart L, Sturm T, Schuster M, Nestoriuc Y, Brehm F, Rusch D. A cross-sectional study on preoperative anxiety in adults. J Psychosom Res. 2018 Aug;111:133-139. doi: 10.1016/j.jpsychores.2018.05.012. Epub 2018 May 22. — View Citation

Guo P, East L, Arthur A. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012 Feb;49(2):129-37. doi: 10.1016/j.ijnurstu.2011.08.008. Epub 2011 Sep 22. — View Citation

Laufenberg-Feldmann R, Kappis B, Schuster M, Ferner M. [Relevance of preoperative anxiety for postoperative outcome in urological surgery patients: A prospective observational study]. Schmerz. 2016 Apr;30(2):166-73. doi: 10.1007/s00482-015-0023-3. German. — View Citation

Navarro-Garcia MA, Marin-Fernandez B, de Carlos-Alegre V, Martinez-Oroz A, Martorell-Gurucharri A, Ordonez-Ortigosa E, Prieto-Guembe P, Sorbet-Amostegui MR, Indurain-Fernandez S, Elizondo-Sotro A, Irigoyen-Aristorena MI, Garcia-Aizpun Y. [Preoperative mood disorders in patients undergoing cardiac surgery: risk factors and postoperative morbidity in the intensive care unit]. Rev Esp Cardiol. 2011 Nov;64(11):1005-10. doi: 10.1016/j.recesp.2011.06.009. Epub 2011 Sep 15. Spanish. — View Citation

Navarro-Gaston D, Munuera-Martinez PV. Prevalence of Preoperative Anxiety and Its Relationship with Postoperative Pain in Foot Nail Surgery: A Cross-Sectional Study. Int J Environ Res Public Health. 2020 Jun 22;17(12):4481. doi: 10.3390/ijerph17124481. — View Citation

Vergara-Romero M, Morales-Asencio JM, Morales-Fernandez A, Canca-Sanchez JC, Rivas-Ruiz F, Reinaldo-Lapuerta JA. Validation of the Spanish version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Health Qual Life Outcomes. 2017 Jun 7;1 — View Citation

Wu H, Zhao X, Chu S, Xu F, Song J, Ma Z, Gu X. Validation of the Chinese version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Health Qual Life Outcomes. 2020 Mar 11;18(1):66. doi: 10.1186/s12955-020-01294-3. — View Citation

Zelenikova R, Homzova P, Homza M, Buzgova R. Validity and Reliability of the Czech Version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). J Perianesth Nurs. 2017 Oct;32(5):429-437. doi: 10.1016/j.jopan.2016.03.007. Epub 2016 Dec 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre-surgical anxiety levels	Amsterdam Pre-Operative Anxiety and Information Scale (APAIS) using a 5-point Likert scale, where 1 = not at all and 5 = total.	1 day