Level of Anxiety in Patients Undergoing Invasive Foot Surgery

NCT05948748 | Completed

• 1 other identifier: 08/07/2023
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

In recent decades, preoperative anxiety has been studied by numerous authors from different medical-surgical specialties, however, there are no studies in the scientific literature on anxiety prior to surgical procedures in the area of minimally invasive foot surgery at the osteoarticular level. The aim of the present study was to determine the level of preoperative anxiety and information using the Amsterdam Preoperative Anxiety and Information scale in patients undergoing minimally invasive podiatric surgery, as well as to determine the socio-demographic and surgical factors associated with preoperative anxiety.

Conditions

Anxiety Postoperative; Surgery

Keywords

anxiety; surgery; minor surgical procedures; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Anxiety levels

pre-surgical anxiety levels in patients undergoing minimally invasive osteoarticular foot surgery

Procedure: foot surgery

Interventions

foot surgery PROCEDURE

minimally invasive osteoarticular foot surgery

Anxiety levels

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing minimally invasive osteoarticular foot surgery

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica de Ávila: lead

Study Sites (1)

Jorge V Velázquez Saornil

Ávila, Avila, 05005, Spain

Location

Related Publications (8)

• 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.

  PMID: 26242358 BACKGROUND

• 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.

  PMID: 21943828 BACKGROUND

• 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.

  PMID: 21924811 BACKGROUND

• 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.

  PMID: 32580413 RESULT

• 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.

  PMID: 28938978 RESULT

• 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.

  PMID: 32160883 RESULT

• 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.

  PMID: 29935747 RESULT

• 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;15(1):120. doi: 10.1186/s12955-017-0695-8.

  PMID: 28592310 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: July 17, 2023
• Study Start: July 10, 2023
• Primary Completion: September 10, 2023
• Study Completion: January 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)