C23.888.592.612.081DEF IINCT05527600
Evaluation of an App Based on Artificial Intelligence for Pain Assessment in Pediatric Department
An observational study of C23.888.592.612.081, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Accurate assessment of pain in Pediatric Department is challenging. However, recent publications highlight that children do not receive optimal pain management, particularly in Emergency Departments. An Artificial Intelligence-based tool could help physicians to optimize analgesia use. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- C23.888.592.612.081
- What is being tested?
- intensity of acute pain evaluation
- How many people
- 2,500 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Mar 2023to 12 Sep 2023
- 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 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 2000 patients under 18 year old admitted in Emergency Department
Who may be able to join
- Child under 18
- Informed and written consent of a parent or guardian (only 1 accompanying person allowed).
Who cannot join
- Language barrier.
- Refusal to participate by parents/children
- Sign of collapsus, or in serious clinical condition (stage I or II) requiring absolute emergency care,
- Delayed mental or staturo-ponderal development
- Facial injury or wound, presence of a bandage on the face, pre-existing facial deformity
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nice
Nice, CHU de NICE, 06003
Hopital pédiatrique Fondation Lenval
Nice, 06000
About this study
Official title: Development and Validation of a System Based on Digital Face Recognitation for Pain Assessment in Children's Emergency
Accurate assessment of pain in Pediatric Department is challenging. However, recent publications highlight that children do not receive optimal pain management, particularly in Emergency Departments.
An Artificial Intelligence-based tool could help physicians to optimize analgesia use.
Read the detailed description
Acute pain is the reason that the majority of patients present to the Emergency Department. Multiple studies conducted over many years have demonstrated that pain is poorly managed in the Emergency Department. This phenomenon has been referred to in the Medical Literature as "Oligoanalgesia.". Morever, untreated pain can have short and long term effects in Pediatric population, including sensitisation to pain episodes in later life and can affects the Neurodevelopment of the child.
The generally accepted standard for pain assessment is self-reported; however, in preverbal children who cannot communicate their pain, age-appropriate behavioural or observational pain assessment tools are recommended. Because children are not always able to voice their feelings, they completely depend on their caregiving team for the interpretation and management of their pain and discomfort. Thus, accurately validated scales to assess pain levels are crucial. In France, the EVENDOL is the most used widely scale. The EVENDOL scale (from the French Evaluation Enfant Douleur) is used to evaluate pain in children in any situation covering a wider age group than other pain scales (birth up to seven years). Despite a large number of scales with a variety of Psychometric properties having been published in the last decades, to date, there is no criterion standard when considering the assessment of pain. As a result, children continue to be suffered pain without adequate pain management. International guidelines incorporate the need for prompt recognition of pain.
Artificial Intelligence (AI) in Medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. AI in this field can be used to support clinician decision making, allow curiosity-driven care, remove the need to complete mundane tasks, improve communication, and facilitate collaboration. Evaluation of the face is central to all observational pain assessment tools, as the face is highly accessible and facial expressions are considered the most encodable feature of pain Therefore.the investigators aim to develop, validate and asses a system based on Digital Face Recognitation for pain assessment in the Children's Department.
- Conditions
- C23.888.592.612.081
- Being tested
- intensity of acute pain evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity of acute pain evaluationDiagnostic test
the facial expression of each patient will be collected from a short video of 10 seconds, follow by with the evaluation of the pain intensity.
| Study group | Role | What they receive |
|---|---|---|
| assessment of pain in Pediatric Department | 2000 children patients admitted in emmergency department Receives: Diagnostic Test: intensity of acute pain evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of The intensity of acute pain with the EVENDOL Scale
The intensity of acute pain will be assessed by the current reference French methods for evaluating pain in children with the EVENDOL Scale (reference between 0 and 7 years).
Measured: day 0
assessment of The intensity of acute pain with the VAS Scale
The intensity of acute pain will be assessed by the current reference French methods for evaluating pain in children with the VAS Scale (Age > 7 years)
Measured: day 0
the facial expression captured by short video
a short 10-second video is collected to assess facial expression of pain in children
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start7 Mar 2023
- Primary completion7 Mar 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C23.888.592.612.081Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527600
- Sponsor's protocol ID
- 21-PP-16
- Other IDs
- 2021-A02726-35
- Acronym
- DEF II
- Status last verified
- Jan 2024
- First submitted
- 30 Aug 2022
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a System Based on Digital Face Recognitation for Pain Assessment in Children's Emergency
- ClinicalTrials.gov ID
- NCT05527600
- Acronym / sponsor ID
- DEF II / 21-PP-16
- Conditions
- C23.888.592.612.081
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 2 Sep 2022 (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.
Accurate assessment of pain in Pediatric Department is challenging. However, recent publications highlight that children do not receive optimal pain management, particularly in Emergency Departments.
An Artificial Intelligence-based tool could help physicians to optimize analgesia use.
Detailed description
Acute pain is the reason that the majority of patients present to the Emergency Department. Multiple studies conducted over many years have demonstrated that pain is poorly managed in the Emergency Department. This phenomenon has been referred to in the Medical Literature as "Oligoanalgesia.". Morever, untreated pain can have short and long term effects in Pediatric population, including sensitisation to pain episodes in later life and can affects the Neurodevelopment of the child.
The generally accepted standard for pain assessment is self-reported; however, in preverbal children who cannot communicate their pain, age-appropriate behavioural or observational pain assessment tools are recommended. Because children are not always able to voice their feelings, they completely depend on their caregiving team for the interpretation and management of their pain and discomfort. Thus, accurately validated scales to assess pain levels are crucial. In France, the EVENDOL is the most used widely scale. The EVENDOL scale (from the French Evaluation Enfant Douleur) is used to evaluate pain in children in any situation covering a wider age group than other pain scales (birth up to seven years). Despite a large number of scales with a variety of Psychometric properties having been published in the last decades, to date, there is no criterion standard when considering the assessment of pain. As a result, children continue to be suffered pain without adequate pain management. International guidelines incorporate the need for prompt recognition of pain.
Artificial Intelligence (AI) in Medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. AI in this field can be used to support clinician decision making, allow curiosity-driven care, remove the need to complete mundane tasks, improve communication, and facilitate collaboration. Evaluation of the face is central to all observational pain assessment tools, as the face is highly accessible and facial expressions are considered the most encodable feature of pain Therefore.the investigators aim to develop, validate and asses a system based on Digital Face Recognitation for pain assessment in the Children's Department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of pain in Pediatric Department | – | Diagnostic Test: intensity of acute pain evaluation2000 children patients admitted in emmergency department |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 2000 patients under 18 year old admitted in Emergency Department
Key inclusion criteria (2 listed)
- Child under 18
- Informed and written consent of a parent or guardian (only 1 accompanying person allowed).
Key exclusion criteria (5 listed)
- Language barrier.
- Refusal to participate by parents/children
- Sign of collapsus, or in serious clinical condition (stage I or II) requiring absolute emergency care,
- Delayed mental or staturo-ponderal development
- Facial injury or wound, presence of a bandage on the face, pre-existing facial deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensity of acute pain evaluationthe facial expression of each patient will be collected from a short video of 10 seconds, follow by with the evaluation of the pain intensity. | Diagnostic test | assessment of pain in Pediatric Department |
Primary outcome
assessment of The intensity of acute pain with the EVENDOL Scale
Time frame: day 0
The intensity of acute pain will be assessed by the current reference French methods for evaluating pain in children with the EVENDOL Scale (reference between 0 and 7 years).
assessment of The intensity of acute pain with the VAS Scale
Time frame: day 0
The intensity of acute pain will be assessed by the current reference French methods for evaluating pain in children with the VAS Scale (Age > 7 years)
the facial expression captured by short video
Time frame: day 0
a short 10-second video is collected to assess facial expression of pain in children
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 12 Jan 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C23.888.592.612.081, run by Centre Hospitalier Universitaire de Nice at 2 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 2 inclusion and 5 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
assessment of The intensity of acute pain with the EVENDOL Scale (time frame: day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.