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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675945
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

Brief Summary:
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).

Condition or disease
Pain Measurement

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 1576 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)
Actual Study Start Date : October 22, 2018
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 30, 2019



Primary Outcome Measures :
  1. Postoperative pain's evaluation by parents [ Time Frame: 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.

  2. Postoperative pain's evaluation by patients [ Time Frame: 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.


Secondary Outcome Measures :
  1. Evaluation of Pre-operative anxiety of parents [ Time Frame: 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.

  2. Evaluation of Pre-operative anxiety of 7 years old and over patients [ Time Frame: 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.

  3. measure of postoperative adverse events [ Time Frame: from day 0 to day 10 ]
    count of post-surgery events : vomiting, nausea, medical visit using a questionary of mobile phone application



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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children operated in the different centers and leaving home will be included in the study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675945


Locations
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France
Hôpitaaux Pédiatriques de Nice CHU-Lenval
Nice, France
Sponsors and Collaborators
Fondation Lenval
Investigators
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Principal Investigator: Yannick Walrave, MD Fondation Lenval - Nice Children Hospital CHU-Lenval
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT03675945    
Other Study ID Numbers: 18-HPNCL-05
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms