- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07593794
QoR-15T in Cardiac Surgery (QoR15T-CARDİAC)
May 12, 2026 updated by: Kocaeli City Hospital
Validity and Reliability of the Turkish Quality of Recovery-15 (QoR-15T) Scale in Cardiac Surgery Patients: A Prospective Observational Cohort Study
The objective of this prospective observational cohort study is to evaluate the validity, reliability, and responsiveness of the Turkish version of the Quality of Recovery-15 (QoR-15T) scale in adult patients undergoing elective cardiac surgery.
While the QoR-15T has been validated for general surgery in Turkey, its performance remains to be established in high-risk cardiac surgery populations involving cardiopulmonary bypass and intensive care stays.Approximately 150 patients at Kocaeli City Hospital will be enrolled.
The study will compare the patients' QoR-15T scores-recorded preoperatively and on the 7th postoperative day-with the Global Recovery Visual Analog Scale (VAS) to determine construct validity.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
150
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
N/A
Sampling Method
Non-Probability Sample
Study Population
The study population consists of adult patients (aged 18 and over) who are scheduled for elective cardiac surgery (including coronary artery bypass grafting, valve replacement or repair, and aortic surgery) at Kocaeli City Hospital.
Description
Inclusion Criteria:
- Adult patients aged 18 years and older.
- Patients scheduled for elective cardiac surgery (CABG, valve replacement, or aortic surgery).
- Patients capable of understanding and answering the Turkish version of the QoR-15 questionnaire.
- Patients who provide written informed consent.
Exclusion Criteria:
- Emergency surgeries or revision surgeries
- Patients with severe cognitive impairment or psychiatric disorders that prevent completion of the scale
- Patients who refuse to participate at any stage.
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 |
|---|---|---|
|
Postoperative Quality of Recovery Score (QoR-15T)
Time Frame: Postoperative Day 7 (or discharge day if earlier)
|
The Turkish version of the 15-item Quality of Recovery scale (QoR-15T).
Each item is scored 0-10.
Total score ranges from 0 to 150
|
Postoperative Day 7 (or discharge day if earlier)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Recovery Visual Analog Scale (VAS)
Time Frame: Postoperative Day 7
|
A self-reported scale where patients rate their overall recovery on a line from 0 to 100 (0 = poor recovery, 100 = excellent recovery).
This will be used to assess the construct validity of the QoR-15T
|
Postoperative Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
September 15, 2026
Study Registration Dates
First Submitted
May 12, 2026
First Submitted That Met QC Criteria
May 12, 2026
First Posted (Actual)
May 18, 2026
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- KSH_ZYT_2
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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