Acute Pre and Post Operative PainDEF-INCT03957967
Acute Pain Assessment Using Facial Expression Analysis
An observational study of Acute Pre and Post Operative Pain, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Managing pain, which affects 20-50% of the population, is a major issue in daily clinical practice. Evaluation of pain intensity is essential to adapt treatment but as it mainly relies on self-report, this assessment is difficult or impossible in non-communicating patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pre and Post Operative Pain
- What is being tested?
- video taken
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2019to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patient undergoing in our institution and accepting to participate
Who may be able to join
- Any adult patient undergoing surgery in our institution during the study duration,
- able to express pain intensity on NRS
Who cannot join
- patient to be operated on in the area of the face or eye
- Patient with altered facial morphology related to a dressing, suture, wound, trauma or oedema on the face
- patient not compliant or unable to clearly express pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Digital Solution for Acute Pain Assessment Using Automartized Facial Expression Analysis
Managing pain, which affects 20-50% of the population, is a major issue in daily clinical practice. Evaluation of pain intensity is essential to adapt treatment but as it mainly relies on self-report, this assessment is difficult or impossible in non-communicating patients. In these cases, pain can only be evaluated by medical staff by the observation of pain-related characteristics like facial expression of pain (FEP). However, recognition of FEP is subjective, time-consuming and subject to multiple biases frequently leading to underestimation of pain and consequently under-treatment. Some of these biases could be solved by the use of facial recognition technology, allowing objective, automated and time-saving pain assessment. DEF-I aims to address technical issues and achieve the development of facial expression recognition digital tool able to evaluate severe acute pain in clinical practice, with high validity and utility by improving the quality of the images to be analyzed, by studying larger samples of patients, data and images, in order to correlate more efficiently the pain intensity felt by a patient with the expression of his face. The main objective of this study is to verify whether it is possible to quantitatively correlate the intensity of acute postoperative pain felt by a patient with his facial expression. The secondary objective is to define a reliable computer algorithm that qualitatively correlates the type of acute postoperative pain experienced by a patient with his facial expression.
- Conditions
- Acute Pre and Post Operative Pain
- Being tested
- video taken
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video takenOther
Patients enrolled will be operated in our institution. Facial expression will be collected before and after surgery, and pain intensity will be collected at the same time. Facial expression will be analyzed using Facial Action Coding System (FACS) .This step will seek to confirm that the subset of Action Units (AUs) defined in previous studies is correlated with the presence and intensity of an acute pain or to identify a different original subset of facial AUs better correlated to pain intensity. . The developed algorithm (or model) here should be able to correlate facial AUs to pain intensity reported by the patients on the numerical rating scale. The developed model at this stage will be then validated on an additional sample of patients.
| Study group | Role | What they receive |
|---|---|---|
| acute pain | Patient with acute pain Receives: Other: video taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of pain
numerical rating scale (NRS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a NRS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The range is 0=no pain to 10=acute pain
Measured: t0=before surgery
measure of pain
numerical rating scale (NRS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a NRS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The range is 0=no pain to 10=acute pain
Measured: t1=after surgery
Secondary outcomes (2)
facial expression
facial photographs extracted from a hort 10 seconds video
Measured: t0=before surgery
facial expression
facial photographs extracted from a hort 10 seconds video
Measured: t1=after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start31 May 2019
- Primary completion31 May 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pre and Post Operative PainStudies 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
- 1,000 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
- NCT03957967
- Sponsor's protocol ID
- 18-PP-13
- Acronym
- DEF-I
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Digital Solution for Acute Pain Assessment Using Automartized Facial Expression Analysis
- ClinicalTrials.gov ID
- NCT03957967
- Acronym / sponsor ID
- DEF-I / 18-PP-13
- Conditions
- Acute Pre and Post Operative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 21 May 2019 (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.
Managing pain, which affects 20-50% of the population, is a major issue in daily clinical practice. Evaluation of pain intensity is essential to adapt treatment but as it mainly relies on self-report, this assessment is difficult or impossible in non-communicating patients. In these cases, pain can only be evaluated by medical staff by the observation of pain-related characteristics like facial expression of pain (FEP). However, recognition of FEP is subjective, time-consuming and subject to multiple biases frequently leading to underestimation of pain and consequently under-treatment. Some of these biases could be solved by the use of facial recognition technology, allowing objective, automated and time-saving pain assessment. DEF-I aims to address technical issues and achieve the development of facial expression recognition digital tool able to evaluate severe acute pain in clinical practice, with high validity and utility by improving the quality of the images to be analyzed, by studying larger samples of patients, data and images, in order to correlate more efficiently the pain intensity felt by a patient with the expression of his face. The main objective of this study is to verify whether it is possible to quantitatively correlate the intensity of acute postoperative pain felt by a patient with his facial expression. The secondary objective is to define a reliable computer algorithm that qualitatively correlates the type of acute postoperative pain experienced by a patient with his facial expression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute pain | – | Other: video takenPatient with acute pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient undergoing in our institution and accepting to participate
Key inclusion criteria (2 listed)
- Any adult patient undergoing surgery in our institution during the study duration,
- able to express pain intensity on NRS
Key exclusion criteria (3 listed)
- patient to be operated on in the area of the face or eye
- Patient with altered facial morphology related to a dressing, suture, wound, trauma or oedema on the face
- patient not compliant or unable to clearly express pain
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 |
|---|---|---|
| video takenPatients enrolled will be operated in our institution. Facial expression will be collected before and after surgery, and pain intensity will be collected at the same time. Facial expression will be analyzed using Facial Action Coding System (FACS) .This step will seek to confirm that the subset of Action Units (AUs) defined in previous studies is correlated with the presence and intensity of an acute pain or to identify a different original subset of facial AUs better correlated to pain intensity. . The developed algorithm (or model) here should be able to correlate facial AUs to pain intensity reported by the patients on the numerical rating scale. The developed model at this stage will be then validated on an additional sample of patients. | Other | acute pain |
Primary outcome
measure of pain
Time frame: t0=before surgery
numerical rating scale (NRS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a NRS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The range is 0=no pain to 10=acute pain
measure of pain
Time frame: t1=after surgery
numerical rating scale (NRS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a NRS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The range is 0=no pain to 10=acute pain
2 secondary outcomes
facial expression
Time frame: t0=before surgery
facial expression
Time frame: t1=after surgery
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 16 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Pre and Post Operative Pain, run by Centre Hospitalier Universitaire de Nice 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 2 inclusion and 3 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 16 Mar 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?
measure of pain (time frame: t0=before surgery). 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?
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 16 Mar 2020.