Validation of the Greek Postoperative Quality of Recovery Score 15 ((QoR-15Gr))

November 22, 2024 updated by: DESPOINA LIOTIRI, IASO Thessalias

Cultural Adaptation and Validation of the Greek Version of the Postoperative Quality of Recovery Score 15 (QoR-15Gr)

The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to culturally adapt and validate a Greek version of the Quality of Recovery - 15 (QoR-15), referred to as the QoR-15Gr, for Greek-speaking surgical patients. The investigators hypothesize that the QoR-15Gr will demonstrate psychometric properties comparable to the original English version.

Study Type

Observational

Enrollment (Estimated)

150

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 Contact Backup

  • Name: NIKOLAOS BEIS, SURGICAL TRAINEE
  • Phone Number: 00306984033002
  • Email: mpeis_nik@yahoo.gr

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41005
        • IASO Thessalias General Hospital
        • Contact:
        • Principal Investigator:
          • DESPOINA LIOTIRI, ANAESTHESIOLOGIST
        • Principal Investigator:
          • NIKOLAOS BEIS, SURGICAL TRAINEE
        • Sub-Investigator:
          • ATHINA SAMARA, GYNAECOLOGY TRAINEE
        • Sub-Investigator:
          • ALEXANDROS DIAMANTIS, SURGEON
        • Sub-Investigator:
          • DIMITRIOS ZACHAROULIS, PROFESSOR OF SURGERY

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

The study will take place in IASO Thessalias General Hospital (the largest private general hospital in the region of Thessaly in Greece).

Description

Inclusion Criteria:

  • Age>18 years old
  • Scheduled elective general surgery under general anesthesia

Exclusion Criteria:

  • Emergency surgery
  • Poor Greek comprehension
  • Inability to give consent
  • A psychiatric or neurological condition that precludes cooperation
  • Known history of alcohol or drug dependence
  • Life-threatening postoperative complications
  • Postoperative admission to ITU

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Translation and cultural adaptation of the Greek version of the postoperative quality of recovery score 15 (QoR-15Gr)
Time Frame: From enrollment until 20 first patient have been enrolled

The QoR-15 consists of 15 questions and the patients are asked to rate various aspects of their postoperative recovery from 0 to 10. Minimum score is 0 and corresponds to the worst score. Maximum score is 150 and corresponds to optimal recovery.

Translation into Greek and pilot test will be performed.
From enrollment until 20 first patient have been enrolled
Psychometric properties of postoperative quality of recovery 15 (QoR-15Gr) will be assessed by evaluating validity (convergent, construct, and discriminant), reliability (internal consistency and repeatability), and responsiveness.
Time Frame: From enrollment until 150 patients have been enrolled
From enrollment until 150 patients have been enrolled
Acceptability and feasibility of the postoperative quality of recovery 15 (QoR-15Gr) will be assessed by measuring patient recruitment rate as well as successful recruitment rate.
Time Frame: From enrollment until 150 patients have been enrolled
From enrollment until 150 patients have been enrolled

Collaborators and Investigators

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

Sponsor

IASO Thessalias

Investigators

  • Principal Investigator: DESPOINA LIOTIRI, ANAESTHESIOLOGIST, IASO Thessalias General Hospital
  • Study Chair: DIMITRIOS ZACHAROULIS, PROFESSOR OF SURGERY, University of Thessaly

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 785

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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