Spanish Validation and Cross-cultural Adaptation of the QoR-15E

December 27, 2021 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Comitè Ètic d'Investigació Clínica HUVH

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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
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.
1 year

Collaborators and Investigators

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Study Director: Susana Manrique Muñoz, MD, PhD, Hospital Vall d'Hebron
  • Study Director: Miriam de Nadal Clanchet, MD, PhD, Hospital Vall d'Hebron

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 (Actual)

December 2, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AG)620/2020

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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