- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04726605
Turkish Version of the Postoperative QoR-15 (QoR-15T)
February 19, 2023 updated by: Umut Kara, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Translation and Validation of the Turkish Version of the Postoperative Quality of Recovery Score QoR-15
Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials.
The QoR-15 was designed to measure quality of recovery after surgery.
It provided an efficient evaluation of the postoperative quality of recovery.
The primary objectives of this study is to translate the original QoR-15 questionnaire into Turkish, and do a full psychometric evaluation of the Turkish version.
We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, orthopedic, gynecological, urologic, eye and ENT surgery, in the University of Health Sciences, Gülhane Education and Rraining Hospital Ankara, Türkiye.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
250
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
-
-
Ankara
-
Etlik, Ankara, Turkey, 06010
- SBÜ Gülhane Education and Training Hospital
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients admitted for any type of scheduled surgery with general anesthesia except heart and vascular surgery
Description
Inclusion Criteria:
- aged > 18 years old
- underwent selective or day surgery with general anesthesia (including all surgical categories except heart and vascular surgery)
- able to complete the QoR-15T in Turkish
- agreed to provide written informed consent to participate
Exclusion Criteria:
- aged < 18 years old
- patients with a neuropsychiatric disturbance
- not agreed to provide written informed consent to participate
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Recovery 15 Score
Time Frame: 24 hours after surgery
|
Postoperative Quality of Recovery 15 in Turkish scale (QoR-15T)
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Lyckner S, Boregard IL, Zetterlund EL, Chew MS. Validation of the Swedish version of Quality of Recovery score -15: a multicentre, cohort study. Acta Anaesthesiol Scand. 2018 Aug;62(7):893-902. doi: 10.1111/aas.13086. Epub 2018 Feb 7.
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)
January 2, 2021
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
January 22, 2021
First Submitted That Met QC Criteria
January 22, 2021
First Posted (Actual)
January 27, 2021
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 19, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2020/246
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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