Level of Anxiety in Patients Undergoing Invasive Foot Surgery

December 5, 2023 updated by: JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila

Preoperative Anxiety Level and Associated Factors in Patients Undergoing Minimally Invasive Osteoarticular Foot Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients undergoing minimally invasive osteoarticular foot surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica de Ávila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Actual)

September 10, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

July 8, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/07/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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