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

NCT07258238 | Not Yet Recruiting

• 1 other identifier: QoR-15Ro
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recovery; Postoperative Care; Postoperative Period; Humans; Anesthesia

Keywords

Quality of Recovery; Postoperative Recovery; QoR-15

Outcome Measures

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.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SUUMC Central Military Hospital Dr Carol Davila: lead

Study Sites (1)

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

Bucharest, 010242, Romania

Location

Related Publications (5)

• 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.

  PMID: 32303379 BACKGROUND

• 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.

  PMID: 36414472 BACKGROUND

• 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.

  PMID: 29397134 BACKGROUND

• 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.

  PMID: 35430086 BACKGROUND

• 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.

  PMID: 23411725 BACKGROUND

Central Study Contacts

Cristian Blajut, MD, FACS

CONTACT

+40747128688; cristi.blajut@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)