NCT05114967

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

November 9, 2021

Last Update Submit

February 9, 2022

Conditions

AnxietyPandemic, COVID-19

Keywords

AnxietySARS CoV-2PandemicPerioperative

Outcome Measures

Primary Outcomes (1)

  • Anxiety level

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

    Before surgery

Secondary Outcomes (1)

  • Factors accentuating the anxiety levels

    Before surgery

Study Arms (1)

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

Interventions

mPAS questionnaireOTHER

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

Patients undergoing surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult consecutive patients, \>18 years old who will undergo surgery for one month in the University Hospital of Larissa

You may qualify if:

  • Adult consecutive patients, \>18 years old
  • Undergoing surgery in the UHL

You may not qualify if:

  • Patients aged\<18 years
  • Patients that will refuse to participate
  • Patients unable/not fit to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Thessaly

Larissa, Thessaly, 41110, Greece

Location

MeSH Terms

Conditions

Anxiety DisordersCOVID-19

Condition Hierarchy (Ancestors)

Mental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eleni Arnaoutoglou, MD, PhD

    University of Thessaly

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 10, 2021

Study Start

December 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 12, 2022

Last Updated

February 11, 2022

Record last verified: 2022-02

Locations

GR(1)