SurgeryFQoR-15NCT03967821
Translation and Validation of the French Quality of Recovery (QoR-15) Questionnaire - Postoperative Recovery Assessment Questionnaire
An observational study of Surgery, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Questionnaire
- How many people
- 375 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients admitted for any type of scheduled surgery except intracranial
Who may be able to join
- 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.
Who cannot join
- Psychiatric or neurological pathology compromising cooperation in the validation protocol of the questionnaire;
- Hospitalized for intracranial surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
RINEAU Emmanuel
Angers
RINEAU Emmanuel, MD, 0241354549 ext. +33, emmanuel.rineau@chu-angers.fr
About this study
Official title: Translation and Validation of the French Quality of Recovery Questionnaire (QoR-15) Postoperative Recovery Assessment Questionnaire
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
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Each patient complete FQoR-15 questionnaire 3 times (before surgery, on Day 1, on Day 2)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the validity of the French version of FQoR-15 to assess post-operative recovery from general or loco-regional anaesthesia
Measured: day 2
Secondary outcomes (3)
To ensure the validity of the questionnaire in the context of general anesthesia versus loco-regional anaesthesia
Measured: day 2
To assess the validity of the questionnaire specifically in the outpatient sub-population, which will be evaluated by telephone
Measured: day 2
to analyze questionnaire validity by type of surgery
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start15 Jul 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967821
- Sponsor's protocol ID
- 49RC19_0096
- Acronym
- FQoR-15
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the French Quality of Recovery Questionnaire (QoR-15) Postoperative Recovery Assessment Questionnaire
- ClinicalTrials.gov ID
- NCT03967821
- Acronym / sponsor ID
- FQoR-15 / 49RC19_0096
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients admitted for any type of scheduled surgery except intracranial
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Psychiatric or neurological pathology compromising cooperation in the validation protocol of the questionnaire;
- Hospitalized for intracranial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireEach patient complete FQoR-15 questionnaire 3 times (before surgery, on Day 1, on Day 2) | Other | Intervention |
Primary outcome
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
3 secondary outcomes
To ensure the validity of the questionnaire in the context of general anesthesia versus loco-regional anaesthesia
Time frame: day 2
To assess the validity of the questionnaire specifically in the outpatient sub-population, which will be evaluated by telephone
Time frame: day 2
to analyze questionnaire validity by type of surgery
Time frame: day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel RINEAU, PhD (665806811 ext. +33, emmanuel.rineau@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.