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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04726605
Other study ID # 2020/246
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2021
Est. completion date July 1, 2021

Study information

Verified date February 2023
Source Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Turkey SBÜ Gülhane Education and Training Hospital Etlik Ankara

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Recovery 15 Score Postoperative Quality of Recovery 15 in Turkish scale (QoR-15T) 24 hours after surgery
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