Surgical InterventionNCT04453410
Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric
An observational study of Surgical Intervention and Minor, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Surgical Intervention, Minor
- What is being tested?
- Questionnaire Quality-of-recovery 15 (QoR-15)
- How many people
- 153 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2020to 14 Dec 2021
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Minor patient over 7 years and up to 17 years and 9 months who have a programming surgery as part of routine management
Who may be able to join
- Patient underage over 7 years and up to 17 years and 9 months
- Programming surgery as part of routine management
- Patient affiliated with a health insurance social
- Parental authority holders and the patient agreeing to participate in the study
Who cannot join
- Patients with severe sensory impairment in preoperation preventing reliable participation in the questionnaire
- Patients at risk of severe cognitive or sensory impairment in postoperative
- Patients with language difficulties in the language of administration of the questionnaire
- Patients who can not express their non-opposition to participation in the study
- Refusal of holders of parental authority and/or refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. it has been recommended in perioperative medecine however, this questionnaire was never adapted and validated for a pediatric surgical population.
The main objective of this protocol is to study the validity, reliability, acceptability and feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15 score.
- Conditions
- Surgical Intervention, Minor
- Being tested
- Questionnaire Quality-of-recovery 15 (QoR-15)
- Keywords
- questionnaire Quality-of-recovery 15 (QoR-15)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire Quality-of-recovery 15 (QoR-15)Other
Children will use the questionnaire Quality-of-recovery 15 (QoR-15)
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Quality-of-recovery 15 score
functional recovery score Questionnaire Quality-of-recovery 15 in pictorial version established at J1 postoperatively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start29 Sep 2020
- Primary completion29 Sep 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical InterventionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453410
- Sponsor's protocol ID
- 7732
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Noll E, De Angelis V, Bopp C, Chauvin C, Talon I, Bennett-Guerrero E, Lefebvre F, Pottecher J. Pictorial adaptation of the quality of recovery 15 scale and psychometric validation into a pediatric surgical population. Sci Rep. 2023 Aug 28;13(1):14085. doi: 10.1038/s41598-023-40673-w.
PubMed 37640781
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric
- ClinicalTrials.gov ID
- NCT04453410
- Acronym / sponsor ID
- 7732
- Conditions
- Surgical Intervention, Minor
- Keywords
- questionnaire Quality-of-recovery 15 (QoR-15)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 1 Jul 2020 (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.
Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. it has been recommended in perioperative medecine however, this questionnaire was never adapted and validated for a pediatric surgical population.
The main objective of this protocol is to study the validity, reliability, acceptability and feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15 score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Minor patient over 7 years and up to 17 years and 9 months who have a programming surgery as part of routine management
Key inclusion criteria (4 listed)
- Patient underage over 7 years and up to 17 years and 9 months
- Programming surgery as part of routine management
- Patient affiliated with a health insurance social
- Parental authority holders and the patient agreeing to participate in the study
Key exclusion criteria (5 listed)
- Patients with severe sensory impairment in preoperation preventing reliable participation in the questionnaire
- Patients at risk of severe cognitive or sensory impairment in postoperative
- Patients with language difficulties in the language of administration of the questionnaire
- Patients who can not express their non-opposition to participation in the study
- Refusal of holders of parental authority and/or refusal of the patient to participate in the study
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 |
|---|---|---|
| Questionnaire Quality-of-recovery 15 (QoR-15)Children will use the questionnaire Quality-of-recovery 15 (QoR-15) | Other | – |
Primary outcome
Questionnaire Quality-of-recovery 15 score
Time frame: 3 months
functional recovery score Questionnaire Quality-of-recovery 15 in pictorial version established at J1 postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 37640781Noll E, De Angelis V, Bopp C, Chauvin C, Talon I, Bennett-Guerrero E, Lefebvre F, Pottecher J. Pictorial adaptation of the quality of recovery 15 scale and psychometric validation into a pediatric surgical population. Sci Rep. 2023 Aug 28;13(1):14085. doi: 10.1038/s41598-023-40673-w.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgical Intervention and Minor, run by University Hospital, Strasbourg, France 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Quality-of-recovery 15 score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453410, which also lists 1 linked publication.
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 22 Aug 2023.