HumansNCT04699500
Spanish Validation and Cross-cultural Adaptation of the QoR-15E
An observational study of Humans and Reproducibility of Results, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The satisfactory recovery of the patient after a surgery with an anesthetic request is very important for a quality and excellence assistance. The quality of recovery questionnaire QoR-15 was validated by their authors in 2013 with the study titled development and psychometric evaluation of a postoperative quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humans, Reproducibility of Results, Cross-Cultural Comparison
- How many people
- 242 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2020to 31 Aug 2021
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 be made up of adult patients who undergo a surgical intervention as a therapeutic or diagnostic procedure (general surgery, urology and gynecology) that require an anesthetic technique in the General Area of the Vall d'Hebron University Hospital, whose intended destination after the procedure would be the post-anesthetic recovery unit, before hospital discharge
Who may be able to join
- Patients over 18 years old.
- Comprehensive and sign informed consent.
- Knows and understands the Spanish language.
- Undergo a scheduled surgical intervention under any type of anesthetic procedure from the specialties of general surgery, urology and gynecology.
- 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 Spanish language.
- Surgical intervention from other specialties than general surgery, urology and gynecology.
- Score < 27 points in the Mini Mental State Examination (MMSE) test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spanish Validation and Cross-cultural Adaptation of the QoR-15 Post-anesthetic Recovery Quality Questionnaire: The QoR-15E
The satisfactory recovery of the patient after a surgery with an anesthetic request is very important for a quality and excellence assistance. The quality of recovery questionnaire QoR-15 was validated by their authors in 2013 with the study titled development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. This questionnaire allows a comprehensive assessment by associating the physiological parameters until then assessed with the subjective personal perception of the patient of his state of health. With the consent of its original author, this study is carried out to validate the questionnaire in Spanish and adapted to our environment.
- Conditions
- Humans, Reproducibility of Results, Cross-Cultural Comparison, Surveys and Questionnaires, Postoperative Period, Anesthetics
- Keywords
- Quality, Recovery, Anesthesia, Validation, Adaptation, Spanish
What is being measured
The primary outcome is the main question the study is designed to answer.
Spanish version of the Quality of Recovery 15 questionnaire: The QoR-15E.
The aim of this study is to carry out cross-cultural adaptation and validate the postoperative questionnaire QoR-15 to the Spanish 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: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start2 Dec 2020
- Primary completion1 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HumansStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 242 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana Manrique Muñoz, MD, PhD, Study director, Hospital Vall d'HebronMiriam de Nadal Clanchet, MD, PhD, Study director, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699500
- Sponsor's protocol ID
- PR(AG)620/2020
- Status last verified
- Dec 2021
- First submitted
- 5 Jan 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 23411725Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540Kleif J, Edwards HM, Sort R, Vilandt J, Gogenur I. Translation and validation of the Danish version of the postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand. 2015 Aug;59(7):912-20. doi: 10.1111/aas.12525. Epub 2015 Apr 13.
PubMed 25867135Sa AC, Sousa G, Santos A, Santos C, Abelha FJ. Quality of Recovery after Anesthesia: Validation of the Portuguese Version of the 'Quality of Recovery 15' Questionnaire. Acta Med Port. 2015 Sep-Oct;28(5):567-74. doi: 10.20344/amp.6129. Epub 2015 Oct 30.
PubMed 26667859Llamas-Velasco S, Llorente-Ayuso L, Contador I, Bermejo-Pareja F. [Spanish versions of the Minimental State Examination (MMSE). Questions for their use in clinical practice]. Rev Neurol. 2015 Oct 16;61(8):363-71. Spanish.
PubMed 26461130Demumieux 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Validation and Cross-cultural Adaptation of the QoR-15 Post-anesthetic Recovery Quality Questionnaire: The QoR-15E
- ClinicalTrials.gov ID
- NCT04699500
- Acronym / sponsor ID
- PR(AG)620/2020
- Conditions
- Humans, Reproducibility of Results, Cross-Cultural Comparison, Surveys and Questionnaires, Postoperative Period, Anesthetics
- Keywords
- Quality, Recovery, Anesthesia, Validation, Adaptation, Spanish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The satisfactory recovery of the patient after a surgery with an anesthetic request is very important for a quality and excellence assistance. The quality of recovery questionnaire QoR-15 was validated by their authors in 2013 with the study titled development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. This questionnaire allows a comprehensive assessment by associating the physiological parameters until then assessed with the subjective personal perception of the patient of his state of health. With the consent of its original author, this study is carried out to validate the questionnaire in Spanish and adapted to our environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study population will be made up of adult patients who undergo a surgical intervention as a therapeutic or diagnostic procedure (general surgery, urology and gynecology) that require an anesthetic technique in the General Area of the Vall d'Hebron University Hospital, whose intended destination after the procedure would be the post-anesthetic recovery unit, before hospital discharge
Key inclusion criteria (5 listed)
- Patients over 18 years old.
- Comprehensive and sign informed consent.
- Knows and understands the Spanish language.
- Undergo a scheduled surgical intervention under any type of anesthetic procedure from the specialties of general surgery, urology and gynecology.
- Score > 26 points in the Mini Mental State Examination (MMSE) test.
Key exclusion criteria (5 listed)
- Patients under 18 years old.
- Not having signed the informed consent.
- Not knowing or understanding the Spanish language.
- Surgical intervention from other specialties than general surgery, urology and gynecology.
- Score < 27 points in the Mini Mental State Examination (MMSE) test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spanish version of the Quality of Recovery 15 questionnaire: The QoR-15E.
Time frame: 1 year
The aim of this study is to carry out cross-cultural adaptation and validate the postoperative questionnaire QoR-15 to the Spanish 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Background: PubMed 23411725Stark 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.
- Background: PubMed 10740540Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
- Background: PubMed 25867135Kleif J, Edwards HM, Sort R, Vilandt J, Gogenur I. Translation and validation of the Danish version of the postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand. 2015 Aug;59(7):912-20. doi: 10.1111/aas.12525. Epub 2015 Apr 13.
- Background: PubMed 26667859Sa AC, Sousa G, Santos A, Santos C, Abelha FJ. Quality of Recovery after Anesthesia: Validation of the Portuguese Version of the 'Quality of Recovery 15' Questionnaire. Acta Med Port. 2015 Sep-Oct;28(5):567-74. doi: 10.20344/amp.6129. Epub 2015 Oct 30.
- Background: PubMed 26461130Llamas-Velasco S, Llorente-Ayuso L, Contador I, Bermejo-Pareja F. [Spanish versions of the Minimental State Examination (MMSE). Questions for their use in clinical practice]. Rev Neurol. 2015 Oct 16;61(8):363-71. Spanish.
- Background: PubMed 32303379Demumieux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Manrique Muñoz, MD, PhD study director
Hospital Vall d'Hebron
Miriam de Nadal Clanchet, MD, PhD study director
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humans and Reproducibility of Results, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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: finished, as of the sponsor's last update on 28 Dec 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spanish version of the Quality of Recovery 15 questionnaire: The QoR-15E. (time frame: 1 year). 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 NCT04699500, which also lists 6 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 28 Dec 2021.