ClinicalTrials.gov
History of Changes for Study: NCT05948748
Level of Anxiety in Patients Undergoing Invasive Foot Surgery
Latest version (submitted December 5, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 14, 2023 None (earliest Version on record)
2 December 5, 2023 Study Status
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Study NCT05948748
Submitted Date:  July 14, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: 08/07/2023
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2023
Overall Status: Recruiting
Study Start: July 10, 2023
Primary Completion: September 10, 2023 [Anticipated]
Study Completion: October 1, 2023 [Anticipated]
First Submitted: July 8, 2023
First Submitted that
Met QC Criteria:		 July 14, 2023
First Posted: July 17, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 July 14, 2023
Last Update Posted: July 17, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Universidad Católica de Ávila
Responsible Party: Principal Investigator
Investigator: JORGE VELAZQUEZ SAORNIL
Official Title: Principal investigator
Affiliation: Universidad Católica de Ávila
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief 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.
Detailed Description:
Open or close this module Conditions
Conditions: Anxiety Postoperative
Surgery
Keywords: anxiety
surgery
minor surgical procedures
postoperative pain
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Other
Time Perspective: Other
Biospecimen Retention:
Biospecimen Description:
Enrollment: 104 [Anticipated]
Number of Groups/Cohorts 1
Target Follow-Up Duration: 3 Months
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Anxiety levels
pre-surgical anxiety levels in patients undergoing minimally invasive osteoarticular foot surgery
 Procedure: foot surgery
minimally invasive osteoarticular foot surgery
Open or close this module Outcome Measures
Primary Outcome Measures:
1. pre-surgical anxiety levels
[ Time Frame: 1 day ]

Amsterdam Pre-Operative Anxiety and Information Scale (APAIS) using a 5-point Likert scale, where 1 = not at all and 5 = total.
Open or close this module Eligibility
Study Population: patients undergoing minimally invasive osteoarticular foot surgery
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Jorge V Velázquez Saornil, PhD.
Telephone: +34920251020
Email: jorge.velazquezsaornil@ucavila.es
Locations: Spain, Avila
Jorge V Velázquez Saornil
[Recruiting]
Ávila, Avila, Spain, 05005
Contact:Contact: Jorge V Velázquez Saornil, PhD. +34920251020 jorge.velazquezsaornil@ucavila.es
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: 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. PubMed 26242358
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. PubMed 21943828
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. PubMed 21924811
[Study Results] 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. PubMed 32580413
[Study Results] 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. PubMed 28938978
[Study Results] 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. PubMed 32160883
[Study Results] 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. PubMed 29935747
[Study Results] 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. PubMed 28592310
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