Pain MeasurementAlgoDARPEFNCT03675945
Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children
An observational study of Pain Measurement, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Pain Measurement
- How many people
- 1,576 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2018to 30 Oct 2019
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children operated in the different centers and leaving home will be included in the study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Pain Measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain's evaluation by parents
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.
Measured: from day 0 until day 10
Postoperative pain's evaluation by patients
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.
Measured: from day 0 until day 10
Secondary outcomes (3)
Evaluation of Pre-operative anxiety of parents
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.
Measured: at the day before surgery
Evaluation of Pre-operative anxiety of 7 years old and over patients
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.
Measured: at the day before surgery
measure of postoperative adverse events
count of post-surgery events : vomiting, nausea, medical visit using a questionary of mobile phone application
Measured: from day 0 to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start22 Oct 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
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 Pain MeasurementStudies 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
- 1,576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Walrave, MD, Principal investigator, Fondation Lenval - Nice Children Hospital CHU-Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675945
- Sponsor's protocol ID
- 18-HPNCL-05
- Acronym
- AlgoDARPEF
- Status last verified
- Jul 2019
- First submitted
- 17 Sep 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walrave Y, Carles M, Evain JN, Ikonomoff T, Marie A, Ludot H, Bourdaud N, Kern D, Lejus-Bourdeau C, Orliaguet G, Rosello O, Ecoffey C, Savoldelli C, Perissier C, Delacquis M, Vare B, Donzeau D, Cousin C, Langlais E, Breaud J, Jonckheer K, Dadure C, De la Briere F; Association of French Pediatric Anaesthesia and Intensive Care Medicine (ADARPEF). A follow-up of pain reported by children undergoing outpatient surgery using a smartphone application: AlgoDARPEF multicenter descriptive prospective study. Pain. 2022 Nov 1;163(11):2224-2231. doi: 10.1097/j.pain.0000000000002620. Epub 2022 Mar 1.
PubMed 35239543
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)
- ClinicalTrials.gov ID
- NCT03675945
- Acronym / sponsor ID
- AlgoDARPEF / 18-HPNCL-05
- Conditions
- Pain Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,576 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 18 Sep 2018 (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.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children operated in the different centers and leaving home will be included in the study
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
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.
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.
3 secondary outcomes
Evaluation of Pre-operative anxiety of parents
Time frame: at the day before surgery
Evaluation of Pre-operative anxiety of 7 years old and over patients
Time frame: at the day before surgery
measure of postoperative adverse events
Time frame: from day 0 to day 10
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 7 Feb 2020.
- Derived from this study: PubMed 35239543Walrave Y, Carles M, Evain JN, Ikonomoff T, Marie A, Ludot H, Bourdaud N, Kern D, Lejus-Bourdeau C, Orliaguet G, Rosello O, Ecoffey C, Savoldelli C, Perissier C, Delacquis M, Vare B, Donzeau D, Cousin C, Langlais E, Breaud J, Jonckheer K, Dadure C, De la Briere F; Association of French Pediatric Anaesthesia and Intensive Care Medicine (ADARPEF). A follow-up of pain reported by children undergoing outpatient surgery using a smartphone application: AlgoDARPEF multicenter descriptive prospective study. Pain. 2022 Nov 1;163(11):2224-2231. doi: 10.1097/j.pain.0000000000002620. Epub 2022 Mar 1.
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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.
Yannick Walrave, MD principal investigator
Fondation Lenval - Nice Children Hospital CHU-Lenval
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 Pain Measurement, run by Fondation Lenval 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 4 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 7 Feb 2020. 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?
Postoperative pain's evaluation by parents (time frame: from day 0 until day 10). The study lists 2 primary outcomes in all. 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 NCT03675945, 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 7 Feb 2020.