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

NCT03967821 | Unknown

• 1 other identifier: 49RC19_0096
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• To ensure the validity of the questionnaire in the context of general anesthesia versus loco-regional anaesthesia

  day 2

• To assess the validity of the questionnaire specifically in the outpatient sub-population, which will be evaluated by telephone

  day 2

• to analyze questionnaire validity by type of surgery

  day 2

Study Arms (1)

Intervention

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients admitted for any type of scheduled surgery except intracranial

You may qualify if:

• 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.

You may not qualify if:

• Psychiatric or neurological pathology compromising cooperation in the validation protocol of the questionnaire;
• Hospitalized for intracranial surgery

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

RINEAU Emmanuel

Angers, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Emmanuel RINEAU, PhD

CONTACT

665806811; emmanuel.rineau@chu-angers.fr

Béatrice GABLE

CONTACT

241356825; begable@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: July 15, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)