Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children (AlgoDARPEF)
Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Data from literature suggest that control of postoperative pain remains difficult and insufficient despite interventions to improve the management of children's home-based postoperative pain. In 2017, a recent Australian prospective audit confirms that pain is still underestimated and under-treated by medical staff and home-based families. Currently, no recent review of pain profiles at home has been performed on the pediatric population in France following general surgery in children. The aim of this study is to evaluate the duration and severity of pain felt by children using a mobile phone application.
The study is an epidemiological, observational, prospective and multicenter trial. All children operated in the different centers and leaving home will be included in the study. The peri-operative analgesic treatment will be left to the discretion of the various centers. In addition to the surgical follow-up, post-operative follow-up at home will be carried out using the smartphone application for all patients.
The use of the application will have been explained during the intervention's programming. The application will be downloaded by the parents at home. Parents will be alerted by notifications when they have tracking data to enter. The primary endpoint will be the evaluation of postoperative pain thanks to PPMP-SF scale. Data on prescribed and administered analgesia, nausea-vomiting, behavioral problems and parental satisfaction will be collected.
Statistical analysis will first include a descriptive study of the population. Qualitative data will be expressed as means and standard deviations, and quantitative data as numbers and percentages. Before carrying out each comparative analysis, the application's conditions of the tests used will be verified. The different tests will be considered significant at the 5% threshold unless otherwise specified.
The expected results are an inventory's objective observation of postoperative pain profiles at home following the different pediatric surgeries in France. The study will also highlight the different risk factors of postoperative pain (type of surgery, parental causes, reasons due to the child, medical causes).
A recent study in Sweden in adult population has shown that systematic e-assessment can improve patients' quality of recovery.
A mobile phone application on postoperative pain assessment in pediatric population would improve the management of children's pain and therefore improve the quality of postoperative recovery at home.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Nice, Francia
- Hôpitaaux Pédiatriques de Nice CHU-Lenval
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- All children operated in the centers participating in the study, regardless of age.
- Possession of a smartphone by one of the two parents.
- Affiliated parent or beneficiary of a Social Security scheme.
- Collection of the non-opposition of one of the parents or the representative of the parental authority
Exclusion Criteria:
- Parents who refused or do not understand the protocol
- Parents who don't have the necessary hardware to download the application for mobile phone
- Non-French parents
- Vulnerable people according to article L1121-6 of the public health code
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative pain's evaluation by parents
Lasso di tempo: from day 0 until day 10
|
Measure of pain with scale Postoperative Pain Measure for Parents Short Form (PPMP-SF) using the mobile phone application.
PPMP-SF scale has 10 items about child behavior.
Each item score is 0 or is 1, score of 0 equals an absent sign, score of 1 equals a present sign.
Total score is 10.
Significant pain is greater than or equal to 6.
|
from day 0 until day 10
|
|
Postoperative pain's evaluation by patients
Lasso di tempo: from day 0 until day 10
|
Measure of pain with auto-evaluation Visual Analog Scale (VAS), using mobile phone application.
VAS score goes from 0 to 10. Significant pain is greater than or equal to 3.
|
from day 0 until day 10
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of Pre-operative anxiety of parents
Lasso di tempo: at the day before surgery
|
Measure of parent Pre-operative anxiety by a visual analog scale using mobile phone application.
Score goes from 0 to 10. Score of 0 equals no anxiety.
Significant anxiety is greater than or equal to 3.
|
at the day before surgery
|
|
Evaluation of Pre-operative anxiety of 7 years old and over patients
Lasso di tempo: at the day before surgery
|
Self-evaluation of pre-operative anxiety with visual scale using mobile phone application.
Score goes from 0 to 10. Score of 0 equals no anxiety.
Significant anxiety is greater than or equal to 3.
|
at the day before surgery
|
|
measure of postoperative adverse events
Lasso di tempo: from day 0 to day 10
|
count of post-surgery events : vomiting, nausea, medical visit using a questionary of mobile phone application
|
from day 0 to day 10
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yannick Walrave, MD, Fondation Lenval - Nice Children Hospital CHU-Lenval
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 18-HPNCL-05
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Misurazione del dolore
-
Cairo UniversityCompletatoSCOPO PAIN (VAS) a 24 ore dopo l'interventoEgitto
-
University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
-
King Abdulaziz UniversityReclutamentoDisturbi temporomandibolari (TMD) | Dolore dell'ATM | Arteterapia | TMJ - orale & amp; chirurgia maxillofaciale | Wilkes 1 e 2 | TMD Art Pain StudyArabia Saudita