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Trial record 59 of 51627 for:    questionnaire

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03967821
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : November 7, 2019
Information provided by (Responsible Party):
University Hospital, Angers

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
Surgery Other: Questionnaire

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Study Type : Observational
Estimated 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 : July 15, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

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

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 [ Time Frame: day 2 ]

Secondary Outcome Measures :
  1. To ensure the validity of the questionnaire in the context of general anesthesia versus loco-regional anaesthesia [ Time Frame: day 2 ]
  2. To assess the validity of the questionnaire specifically in the outpatient sub-population, which will be evaluated by telephone [ Time Frame: day 2 ]
  3. to analyze questionnaire validity by type of surgery [ Time Frame: day 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients admitted for any type of scheduled surgery except intracranial

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03967821

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Contact: Emmanuel RINEAU, PhD 665806811 ext +33
Contact: Béatrice GABLE 241356825 ext +33

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RINEAU Emmanuel Recruiting
Angers, France
Contact: RINEAU Emmanuel, MD    0241354549 ext +33   
Sponsors and Collaborators
University Hospital, Angers

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Responsible Party: University Hospital, Angers Identifier: NCT03967821     History of Changes
Other Study ID Numbers: 49RC19_0096
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No