PerioperativeNCT04608968
Pediatric Perioperative Satisfaction Questionnaire
An observational study of Perioperative and Children, run by University Hospital, Montpellier at 6 sites in France.
Trial summary
The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative, Children, Satisfaction
- How many people
- 600 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Sep 2020to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children 7 years and older after surgery
Who may be able to join
- children 7 years and older
- elective surgery
- general anesthesia
- abiliy to understand and read questions
Who cannot join
- emergency
- cognitive trouble
- intellectual disability
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
UH Bordeaux
Bordeaux
Karine, NOUETTE, karine.nouette-gaulain@u-bordeaux.fr
- Recruiting
UH Grenoble
Grenoble
Jean-Noël EVAIN, MD, jnevain@chu-grenoble.fr
- Recruiting
Uhmontpellier
Montpellier, Montpellier, 34295
Sophie BRINGUIER, +33 4 67 33 86 61, fs-bringuierbranchereau@chu-montpellier.fr
- Recruiting
UH Nîmes
Nîmes
Philippe CUVILLON, philippe.cuvillon@chu-nimes.fr
- Recruiting
UH Reims
Reims
Daphné MICHELET, MD, dmichelet@chu-reims.fr
- Recruiting
UH Toulouse
Toulouse
Delphine KERN, MD, kern.d@chu-toulouse.fr
About this study
Official title: Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population
The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.
Read the detailed description
Step 1 : development of the questiontionnaire Face to face interview to report the satisfaction of the children after surgery and to identify recurrent themes to generate questions.
Step 2 : validation of the questionnaire Evaluation of the psychometric validity of the final questionnaire
- Conditions
- Perioperative, Children, Satisfaction
- Keywords
- Validity, Questionnaire, Children, health quality of life, Self report
- Medical subject headings
- Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Children satisfaction after surgery
to develop a questionnaire (score 0 to 100) to assess the satisfaction of children after surgery (from the day of surgery to 2 weeks)
Measured: at discharge of hospital ( from the day of surgery up 14 days)
Secondary outcomes (2)
postoperative pain intensity
to assess the level of children postoperative pain intensity (from the day of surgery to 2 weeks). Pain was assessed using the Face Pain Scale revised tool (0-10).
Measured: at discharge of hospital ( from the day of surgery up 14 days)
perioperative anxiety level
to assess perioperative anxiety level using the Visual Analog Scale (0-10) of children after surgery (from the day of surgery to 2 weeks)
Measured: at discharge of hospital ( from the day of surgery up 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 PerioperativeStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe DADURE, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608968
- Sponsor's protocol ID
- RECHMPL20_0346
- Status last verified
- Nov 2024
- First submitted
- 24 Sep 2020
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Bringuier S, Dadure C, Evain JN, Kern D, Michelet D, Auquier P, Aouinti S, Molinari N, Sola C, Capdevila X, Pico J; EVANpedia Study Group*. Development and Validation of EVANpedia for the Assessment of Perioperative Experience in Pediatric Patients. Anesthesiology. 2026 Jun 1;144(6):1316-1328. doi: 10.1097/ALN.0000000000006038. Epub 2026 Mar 16.
PubMed 41838953
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population
- ClinicalTrials.gov ID
- NCT04608968
- Acronym / sponsor ID
- RECHMPL20_0346
- Conditions
- Perioperative, Children, Satisfaction
- Keywords
- Validity, Questionnaire, Children, health quality of life, Self report
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Oct 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.
The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.
Detailed description
Step 1 : development of the questiontionnaire Face to face interview to report the satisfaction of the children after surgery and to identify recurrent themes to generate questions.
Step 2 : validation of the questionnaire Evaluation of the psychometric validity of the final questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children 7 years and older after surgery
Key inclusion criteria (4 listed)
- children 7 years and older
- elective surgery
- general anesthesia
- abiliy to understand and read questions
Key exclusion criteria (3 listed)
- emergency
- cognitive trouble
- intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Children satisfaction after surgery
Time frame: at discharge of hospital ( from the day of surgery up 14 days)
to develop a questionnaire (score 0 to 100) to assess the satisfaction of children after surgery (from the day of surgery to 2 weeks)
2 secondary outcomes
postoperative pain intensity
Time frame: at discharge of hospital ( from the day of surgery up 14 days)
perioperative anxiety level
Time frame: at discharge of hospital ( from the day of surgery up 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 41838953Bringuier S, Dadure C, Evain JN, Kern D, Michelet D, Auquier P, Aouinti S, Molinari N, Sola C, Capdevila X, Pico J; EVANpedia Study Group*. Development and Validation of EVANpedia for the Assessment of Perioperative Experience in Pediatric Patients. Anesthesiology. 2026 Jun 1;144(6):1316-1328. doi: 10.1097/ALN.0000000000006038. Epub 2026 Mar 16.
- Individual participant dataSharing planned: Undecided. NC
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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.
Christophe DADURE, PhD study director
University Hospital, Montpellier
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative and Children, run by University Hospital, Montpellier at 6 sites 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 3 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sophie Bringuier (04 67 33 86 61 ext. 33, s-bringuierbranchereau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children satisfaction after surgery (time frame: at discharge of hospital ( from the day of surgery up 14 days)). 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 NCT04608968, 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 27 Nov 2024.