NCT06699823

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 19, 2024

Last Update Submit

November 22, 2024

Conditions

Keywords

quality of recoverypatient reported outcomesQoR-15validationcultural adaptation

Outcome Measures

Primary Outcomes (3)

  • Translation and cultural adaptation of the Greek version of the postoperative quality of recovery score 15 (QoR-15Gr)

    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.

    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.

    From enrollment until 150 patients have been enrolled

Interventions

Greek version of QoR-15

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IASO Thessalias General Hospital

Larissa, Thessaly, 41005, Greece

Location

Study Officials

  • DESPOINA LIOTIRI, ANAESTHESIOLOGIST

    IASO THESSALIAS GENERAL HOSPITAL

    PRINCIPAL INVESTIGATOR
  • DIMITRIOS ZACHAROULIS, PROFESSOR OF SURGERY

    University of Thessaly

    STUDY CHAIR

Central Study Contacts

DESPOINA LIOTIRI, ANAESTHESIOLOGIST

CONTACT

NIKOLAOS BEIS, SURGICAL TRAINEE

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 21, 2024

Study Start

December 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations