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HumansQoR-15RoNCT07258238

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

An observational study of Humans and Anesthesia, run by SUUMC Central Military Hospital Dr Carol Davila at 1 site in Romania.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Humans, Anesthesia, Recovery
How many people
250 participants
Where
1 siteRomania
Study dates
1 Jan 2026to 30 Jun 2026
How long will I take part?
15 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cristian Blajut, MD, FACS contact

+40747128688

cristi.blajut@gmail.com

Romania1 site

  • The Central Military University Emergency Hospital "Dr. Carol Davila" in Bucharest

    Bucharest, 010242

    Florin Cristian Blajut, 0747128688, cristi.blajut@gmail.com

Other trials in Romania

About this study

Official title: 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.

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.

Keywords
Quality of Recovery, Postoperative Recovery, QoR-15

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
Target duration
15 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258238
Sponsor's protocol ID
QoR-15Ro
Acronym
QoR-15Ro
Status last verified
Dec 2025
First submitted
20 Nov 2025
Last updated
8 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Humans and Anesthesia, run by SUUMC Central Military Hospital Dr Carol Davila at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cristian Blajut, MD, FACS (+40747128688, cristi.blajut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Romanian version of the Quality of Recovery 15 questionnaire: The QoR-15Ro. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258238, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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