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NCT06456918 Clinical Trial

ValidationTurkishVersionQualityofRecovery-15

Major Abdominal Surgery Clinical Trial

— ValidQoR-15  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06456918
Other study ID # U1111-1309-0952
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 1, 2022

Study information
Verified date June 2024
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 510
Est. completion date December 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Quality of Recovery 15 questionnaire
return to daily life after surgery according to the patient's baseline or social norms

Locations
Country Name City State
Turkey Mehmet Ali Koc Ankara Altindag

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary To validate the QoR-15 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
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