ValidationTurkishVersionQualityofRecovery-15 (ValidQoR-15)

June 9, 2024 updated by: Mehmet Ali Koç, Ankara University

Validation of the Turkish Version of the "Quality of Recovery 15 (QoR-15)" Questionnaire

The aim of this study was to perform a cross-cultural adaptation and psychometric evaluation of the Quality of Recovery 15 questionnaire in Turkey.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The QoR-15 was translated into Turkish through a rigorous process involving independent translations, consensus, back-translation, and review. The questionnaire was administered to patients undergoing elective major gastrointestinal surgery preoperatively and on postoperative days 1, 7, and 30. Reliability was assessed using Cronbach's α and intra-class correlation coefficient. Construct validity was evaluated through confirmatory factor analysis, and responsiveness was analyzed using Cohen's effect size and standardized response mean.

Study Type

Observational

Enrollment (Actual)

510

Contacts and Locations

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

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey, 06230
        • Mehmet Ali Koc

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

Probability Sample

Study Population

510 patients who met the inclusion criteria of being over age of 18 and had a planned elective major gastrointestinal surgery were included in the study.

Description

Inclusion Criteria:

  • being over age of 18 and had a planned elective major gastrointestinal surgery

Exclusion Criteria:

  • under 18 years of age, had an alcohol or substance addiction problem, refused to participate in the study, had a previous major abdominal surgery

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
patients undergoing elective major gastrointestinal surgery
Patients had a planned elective major gastrointestinal surgery.
Procedure: Quality of Recovery 15 questionnaire
return to daily life after surgery according to the patient's baseline or social norms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate the QoR-15
Time Frame: September 2019-September 2022
the survey was conducted on the day before the surgery (Pre), and on postoperative days 1 (P1), 7 (P7), and 30 (P30).
September 2019-September 2022

Collaborators and Investigators

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

Sponsor

Ankara University

Investigators

  • Principal Investigator: Mehmet A Koc, MD, Ankara University

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)

September 1, 2019

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • U1111-1309-0952

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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