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Not yet recruitingNCT07258238QoR-15RoUpdated Dec 8, 2025

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

An observational study in Humans, Anesthesia and Recovery, sponsored by SUUMC Central Military Hospital Dr Carol Davila. Not yet recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by SUUMC Central Military Hospital Dr Carol Davila · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Humans
  • Anesthesia
  • Recovery
  • Postoperative Care
  • Postoperative Period

Keywords

  • Quality of Recovery
  • Postoperative Recovery
  • QoR-15
03

In context

Lead sponsor

SUUMC Central Military Hospital Dr Carol Davila is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
15 Days
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Romanian version of the Quality of Recovery 15 questionnaire: The QoR-15Ro.

    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.

    Time frame: 6 months

07

Study locations

1 site
  • The Central Military University Emergency Hospital "Dr. Carol Davila" in Bucharest
    Bucharest, 010242, Romania
08

References and documents

Publications

  • Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15. PubMed 32303379 ↗
  • Morales-Ariza V, Loaiza-Aldean Y, de Miguel M, Pena-Navarro M, Martinez-Silva O, Gonzalez-Tallada A, Manrique-Munoz S, de Nadal M. Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study. Am J Surg. 2023 Apr;225(4):740-747. doi: 10.1016/j.amjsurg.2022.11.009. Epub 2022 Nov 17. PubMed 36414472 ↗
  • Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. PubMed 29397134 ↗
  • Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14. PubMed 35430086 ↗
  • 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. PubMed 23411725 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07258238
Lead sponsor
SUUMC Central Military Hospital Dr Carol Davila
Responsible party
Blajut Cristian (Consultant Surgeon, SUUMC Central Military Hospital Dr Carol Davila) — Principal investigator
First posted
Dec 2, 2025
Start date
Jan 1, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Dec 8, 2025

Study contacts

Cristian Blajut, MD, FACS
Contact
cristi.blajut@gmail.com
+40747128688

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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