Preoperative Anxiety During COVID-19

Sponsor
University of Thessaly (Other)
Overall Status
Completed
CT.gov ID
NCT05114967
Collaborator
(none)
116
1
1.4
84.1

Study Details

Study Description

Brief Summary

The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al, will be used after permission from the authors, to investigate the preoperative anxiety of patients undergoing surgery during the 4th wave of the pandemic

Condition or Disease Intervention/Treatment Phase
  • Other: mPAS questionnaire

Detailed Description

Studies have been conducted on the stress and anxiety induced by the COVID-19 pandemic in both the general population as well as specific groups, such as health care workers, pregnant women and adolescents. Given that anxiety has a strong bearing on the physical, mental and emotional well-being of the patients and their subsequent recovery from surgery and other procedures, we were interested in assessing anxiety among the patients presenting for elective procedures in the post-lockdown phase of the pandemic. The primary objective of the present study was to assess the anxiety levels among the preoperative patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic, and the secondary objective was to assess the factors accentuating the same. The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al will be used after permission from the authors.

Study Design

Study Type:
Observational
Actual Enrollment :
116 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Preoperative Anxiety Levels in Patients Undergoing Surgery During the 4th Wave of the SARS-CoV-2 Pandemic. A Prospective Observational Study
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Jan 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing surgery

Patients undergoing surgery during the 4th wave of the pandemic for 1 month duration in the University Hospital of Larissa

Other: mPAS questionnaire
The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al will be used after permission from the authors

Outcome Measures

Primary Outcome Measures

  1. Anxiety level [Before surgery]

    The anxiety levels among the preoperative patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic will be measured

Secondary Outcome Measures

  1. Factors accentuating the anxiety levels [Before surgery]

    Factors accentuating the anxiety levels in patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult consecutive patients, >18 years old

  • Undergoing surgery in the UHL

Exclusion Criteria:
  • Patients aged<18 years

  • Patients that will refuse to participate

  • Patients unable/not fit to consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Univeristy of Thessaly Larissa Thessaly Greece 41110

Sponsors and Collaborators

  • University of Thessaly

Investigators

  • Study Chair: Eleni Arnaoutoglou, MD, PhD, University of Thessaly

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier:
NCT05114967
Other Study ID Numbers:
  • COVID-19_Anxiety_UHL
First Posted:
Nov 10, 2021
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022