The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Level of Anxiety in Patients Undergoing Invasive Foot Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 8, 2023
First Posted Date July 17, 2023
Last Update Posted Date December 6, 2023
Actual Study Start Date July 10, 2023
Actual Primary Completion Date September 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2023)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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 Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients undergoing minimally invasive osteoarticular foot surgery
Condition
  • Anxiety Postoperative
  • Surgery
Intervention Procedure: foot surgery
minimally invasive osteoarticular foot surgery
Study Groups/Cohorts Anxiety levels
pre-surgical anxiety levels in patients undergoing minimally invasive osteoarticular foot surgery
Intervention: Procedure: foot surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 14, 2023)		 104
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2024
Actual Primary Completion Date September 10, 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jorge V Velázquez Saornil, PhD. +34920251020 jorge.velazquezsaornil@ucavila.es
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT05948748
Other Study ID Numbers 08/07/2023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
Original Responsible Party Same as current
Current Study Sponsor Universidad Católica de Ávila
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Universidad Católica de Ávila
Verification Date December 2023