- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07510360
Intercultural Adaptation and Validation of the Ukrainian Quality of Recovery-15 Questionnaire
March 30, 2026 updated by: Rostyslav Voloshchuk
The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective.
It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state.
The aim of this study is to validate a Ukrainian version of the QoR-15 scale (QoR-15Ukr) to measure postoperative recovery in Ukrainian-speaking patients.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rostyslav Voloshchuk, MD
- Phone Number: 380971800840
- Email: rostykv@gmail.com
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
Yes
Sampling Method
Non-Probability Sample
Study Population
Adult patients native or fluent in Ukrainian language undergoing surgery.
Description
Inclusion criteria
- Age 18 or older
- Patient scheduled for elective or emergency surgery under general or regional anaesthesia
- Able to read and understand Ukrainian
Exclusion criteria
- Patient unable or unwilling to provide informed consent
- Any severe preexisting medical condition or cognitive impairment that limits objective assessment after operation
- Known substance use disorder associated with cognitive impairment
Withdrawal criteria
1. Presence of life-threatening post-operative complications
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 |
|---|---|
|
Adult patients undergoing surgery
Adult patients native or fluent in Ukrainian and undergoing elective or emergency surgery under general and/or regional anesthesia
|
A 15-item questionnaire covering different aspects of recovery after surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Construct validity of QoR-15Ukr
Time Frame: Preoperative and 24 hour postoperative
|
Correlation between the QoR-15 (0-150) and the following variables:
|
Preoperative and 24 hour postoperative
|
|
Convergent validity of QoR-15Ukr
Time Frame: Preoperative and 24 hour postoperative
|
Correlation between the QoR-15 (0-150) and the following variables: - numerical rating scale (0-10) for overall quality of postoperative recovery, |
Preoperative and 24 hour postoperative
|
|
Responsiveness of QOR-15Ukr
Time Frame: Preoperative and 24 hour postoperative.
|
Cohen's d effect size.
|
Preoperative and 24 hour postoperative.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reliability of QOR-15Ukr
Time Frame: Preoperative and 24 hour postoperative
|
Compare the two QoR-15 results measured at 60 minutes intervals using an intraclass correlation coefficient (test-retest reliability), and calculate the Cronbach alpha to investigate the internal consistency.
|
Preoperative and 24 hour postoperative
|
|
Feasibility of QoR-15Ukr
Time Frame: Preoperative and 24 hour postoperative
|
Time needed to fill in the questionnaire and the rate of completion will be evaluated.
|
Preoperative and 24 hour postoperative
|
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)
October 31, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
March 30, 2026
First Submitted That Met QC Criteria
March 30, 2026
First Posted (Actual)
April 3, 2026
Study Record Updates
Last Update Posted (Actual)
April 3, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- QoR-15Ukr
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data will be deidentified and shared.
IPD Sharing Time Frame
Data will be available for 5 years from the date of publication
IPD Sharing Access Criteria
Data will be uploaded to an publicli accessible repository.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
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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