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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04699500
Collaborator
(none)
242
1
8.9
27.1

Study Details

Study Description

Brief 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 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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
242 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Spanish Validation and Cross-cultural Adaptation of the QoR-15 Post-anesthetic Recovery Quality Questionnaire: The QoR-15E
Actual Study Start Date :
Dec 2, 2020
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Aug 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Spanish version of the Quality of Recovery 15 questionnaire: The QoR-15E. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Comitè Ètic d'Investigació Clínica HUVH Barcelona Spain 08035

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT04699500
Other Study ID Numbers:
  • PR(AG)620/2020
First Posted:
Jan 7, 2021
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

Study Results

No Results Posted as of Dec 28, 2021