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Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children (AlgoDARPEF)

6 februari 2020 uppdaterad av: Fondation Lenval

Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)

Pain is common following surgery in children. Currently, no recent review of pain profiles at home has been performed on 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. All children operated in the different centers and leaving home will be included in the study. Children's pain scores will be measured using PPMP-SF scale (Postoperative Pain Measure for Parents Short Form). Data on prescribed and administered analgesia, nausea-vomiting, behavioral problems and parental satisfaction will be collected. 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).

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

1576

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Nice, Frankrike
        • Hôpitaaux Pédiatriques de Nice CHU-Lenval

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 månad till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

All children operated in the different centers and leaving home will be included in the study

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative pain's evaluation by parents
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Evaluation of Pre-operative anxiety of parents
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Yannick Walrave, MD, Fondation Lenval - Nice Children Hospital CHU-Lenval

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 oktober 2018

Primärt slutförande (Faktisk)

30 oktober 2019

Avslutad studie (Faktisk)

30 oktober 2019

Studieregistreringsdatum

Först inskickad

17 september 2018

Först inskickad som uppfyllde QC-kriterierna

17 september 2018

Första postat (Faktisk)

18 september 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 februari 2020

Senast verifierad

1 juli 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 18-HPNCL-05

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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