Clinical trial NCT05948748: Level of Anxiety in Patients Undergoing Invasive Foot Surgery
Official title: Preoperative Anxiety Level and Associated Factors in Patients Undergoing Minimally Invasive Osteoarticular Foot Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Postoperative
Surgery
Keywords: anxiety
surgery
minor surgical procedures
postoperative pain
Lead sponsor: Universidad Católica de Ávila
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing minimally invasive osteoarticular foot surgery

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.


Eligibility criteria: 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.

Primary outcomes:
measure: pre-surgical anxiety levels
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ávila
country: Spain
facility: Jorge V Velázquez Saornil
state: Avila
Study officials:
References:
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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.
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.
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.
citation: 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.
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;15(1):120. doi: 10.1186/s12955-017-0695-8.