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

Surgery Clinical Trial

— FQoR-15  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03967821
• Other study ID #: 49RC19_0096
• Status: Recruiting
• Start date: July 15, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: May 2019
• Source: University Hospital, Angers
• Contact: Emmanuel RINEAU, PhD
• Phone: 665806811
• Email: emmanuel.rineau[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
France	RINEAU Emmanuel	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To ensure the validity of the questionnaire in the context of general anesthesia versus loco-regional anaesthesia		day 2
Secondary	To assess the validity of the questionnaire specifically in the outpatient sub-population, which will be evaluated by telephone		day 2
Secondary	to analyze questionnaire validity by type of surgery		day 2