FQoR-15: Translation and Validation of the French Quality of Recovery (QoR-15) Questionnaire - Postoperative Recovery Assessment Questionnaire

Sponsor
University Hospital, Angers (Other)
Overall Status
Unknown status
CT.gov ID
NCT03967821
Collaborator
(none)
375
1
14.6
25.7

Study Details

Study Description

Brief Summary

Surgery (under general anaesthesia or under loco-regional anaesthesia) is an event that causes stress, anxiety, pain and even minor complications such as nausea or vomiting. Peri-operative management and the psychological support allocated to each patient will have an impact on the hospitalization experience. Many studies have focused on reducing peri-operative mortality (decrease in pain intensity as measured by analog visual scale, decrease in nausea/vomiting frequency, decrease in remobilization time, etc.) but few assessed the overall recovery of patients. there is a desire to improve physical and psychological recovery, with particular attention to the patient's own feelings. It is essential to evaluate our peri-operative management practices based on patient-centred criteria. In this context, the development of a scale for measuring the quality of post-operative recovery appears to be necessary. In 2013, a questionnaire was quickly run (about 2-3 min): the QoR-15 was validated. This questionnaire is reliable, sensitive, easily achievable in clinical practice, not onerous for the patient and provides information on the post-operative recovery perceived by the patient himself.

The QoR-15 was validated in English, then in Danish, Chinese, Portuguese and more recently in Swedish. It has not yet been validated in French and therefore cannot be used in studies on francophone patients.

Investigator goal is to validate a French version of the QoR-15, the FQoR-15.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
375 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Translation and Validation of the French Quality of Recovery Questionnaire (QoR-15) Postoperative Recovery Assessment Questionnaire
Actual Study Start Date :
Jul 15, 2019
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Intervention

Other: Questionnaire
Each patient complete FQoR-15 questionnaire 3 times (before surgery, on Day 1, on Day 2)

Outcome Measures

Primary Outcome Measures

  1. To assess the validity of the French version of FQoR-15 to assess post-operative recovery from general or loco-regional anaesthesia [day 2]

Secondary Outcome Measures

  1. To ensure the validity of the questionnaire in the context of general anesthesia versus loco-regional anaesthesia [day 2]

  2. To assess the validity of the questionnaire specifically in the outpatient sub-population, which will be evaluated by telephone [day 2]

  3. to analyze questionnaire validity by type of surgery [day 2]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults (18 years old or older)

  • Francophones;

  • Admitted for any type of scheduled surgery;

  • Able to complete the questionnaire upon admission, alone or with the assistance of a third party;

  • Agreeing to participate in the study.

Exclusion Criteria:
  • Psychiatric or neurological pathology compromising cooperation in the validation protocol of the questionnaire;

  • Hospitalized for intracranial surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 RINEAU Emmanuel Angers France

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT03967821
Other Study ID Numbers:
  • 49RC19_0096
First Posted:
May 30, 2019
Last Update Posted:
Nov 7, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 7, 2019