Romanian Validation and Cross-cultural Adaptation of the QoR-15Ro (QoR-15Ro)

December 1, 2025 updated by: Blajut Cristian, SUUMC Central Military Hospital Dr Carol Davila

Romanian Validation and Cross-cultural Adaptation of the QoR-15 Post-anesthetic Recovery Quality Questionnaire: The QoR-15Ro

Optimal postoperative recovery after any surgical procedure requiring anesthesia is essential to achieving high-quality care. The Quality of Recovery questionnaire (QoR-15) was validated by its authors in 2013 in the study "Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15." This instrument enables a comprehensive evaluation by integrating traditional physiological measures with the patient's subjective perception of their health status. With the consent of the original author, the present study aims to validate the Romanian version of the questionnaire and adapt it to our clinical environment.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The goal of this observational study is to validate the Romanian translation of the Quality of Recovery questionnaire (QoR-15) in adult patients undergoing surgery with anesthesia. The study aims to determine whether the Romanian version of the QoR-15 accurately measures postoperative recovery by reflecting both physical and emotional aspects of the patient's health.

The main questions it aims to answer are: Is the Romanian QoR-15 a reliable and consistent tool for evaluating postoperative recovery? AND Does the Romanian QoR-15 accurately capture the patient's own perception of their recovery after anesthesia and surgery? Participants will complete the Romanian version of the QoR-15 within the postoperative period and provide basic demographic and clinical information relevant to their recovery.

Study Type

Observational

Enrollment (Estimated)

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 Contact

Study Locations

  • Romania
      • Bucharest, Romania, 010242
        • The Central Military University Emergency Hospital "Dr. Carol Davila" in Bucharest
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Our study population will consist of adult patients undergoing therapeutic or diagnostic surgical procedures in the specialties of general surgery, urology, neurosurgery, and plastic and reconstructive surgery that require anesthesia. All participants will be treated at the Central Military University Emergency Hospital "Dr. Carol Davila" in Bucharest and are expected to be transferred to the post-anesthetic recovery unit immediately after the procedure, prior to hospital discharge.

Description

Inclusion Criteria:

  • Patients over 18 years old.
  • Comprehensive and sign informed consent.
  • Knows and understands the Romanian language.
  • Undergo a scheduled surgical intervention under any type of anesthetic procedure from the specialties of general surgery, urology, neurosurgery, plastic and reconstructive surgery.
  • Score > 26 points in the Mini Mental State Examination (MMSE) test.

Exclusion Criteria:

  • Patients under 18 years old.
  • Not having signed the informed consent.
  • Not knowing or understanding the Romanian language.
  • Surgical intervention from other specialties than general surgery, urology, neurosurgery, plastic and reconstructive surgery.
  • Score < 27 points in the Mini Mental State Examination (MMSE) test.

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
Romanian version of the Quality of Recovery 15 questionnaire: The QoR-15Ro.
Time Frame: 6 months

The aim of this study is to carry out cross-cultural adaptation and validate the postoperative questionnaire QoR-15 in the Romanian environment and evaluate its validity and reliability.

This questionnaire consists of 15 items with a total score of 150 points, where 150 points is better than 0 points for the patient.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SUUMC Central Military Hospital Dr Carol Davila

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

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)

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QoR-15Ro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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