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Level of Anxiety in Patients Undergoing Invasive Foot Surgery

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ClinicalTrials.gov Identifier: NCT05948748
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Study Description
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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.

Condition or disease Intervention/treatment
Anxiety Postoperative Surgery Procedure: foot surgery

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 104 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 3 Months
Official Title: Preoperative Anxiety Level and Associated Factors in Patients Undergoing Minimally Invasive Osteoarticular Foot Surgery
Actual Study Start Date : July 10, 2023
Actual Primary Completion Date : September 10, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Foot Health

Groups and Cohorts
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Group/Cohort Intervention/treatment
Anxiety levels
pre-surgical anxiety levels in patients undergoing minimally invasive osteoarticular foot surgery
 Procedure: foot surgery
minimally invasive osteoarticular foot surgery


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing minimally invasive osteoarticular foot surgery
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05948748


Contacts
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Contact: Jorge V Velázquez Saornil, PhD. +34920251020 jorge.velazquezsaornil@ucavila.es

Locations
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Spain
Jorge V Velázquez Saornil Recruiting
Ávila, Avila, Spain, 05005
Contact: Jorge V Velázquez Saornil, PhD.    +34920251020    jorge.velazquezsaornil@ucavila.es   
Sponsors and Collaborators
Universidad Católica de Ávila
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

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Responsible Party: JORGE VELAZQUEZ SAORNIL, Principal investigator, Universidad Católica de Ávila
ClinicalTrials.gov Identifier: NCT05948748    
Other Study ID Numbers: 08/07/2023
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila:
anxiety
surgery
minor surgical procedures
postoperative pain
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders