- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957967
Acute Pain Assessment Using Facial Expression Analysis (DEF-I)
March 12, 2020 updated by: Centre Hospitalier Universitaire de Nice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nice, France, 06000
- Hopital PASTEUR
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
any patient undergoing in our institution and accepting to participate
Description
Inclusion Criteria:
- Any adult patient undergoing surgery in our institution during the study duration,
- able to express pain intensity on NRS
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
acute pain
Patient with acute pain
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
t0=before surgery
|
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
|
t1=after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
facial expression
Time Frame: t0=before surgery
|
facial photographs extracted from a hort 10 seconds video
|
t0=before surgery
|
facial expression
Time Frame: t1=after surgery
|
facial photographs extracted from a hort 10 seconds video
|
t1=after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 31, 2019
Primary Completion (ACTUAL)
May 31, 2019
Study Completion (ACTUAL)
November 30, 2019
Study Registration Dates
First Submitted
May 6, 2019
First Submitted That Met QC Criteria
May 20, 2019
First Posted (ACTUAL)
May 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 16, 2020
Last Update Submitted That Met QC Criteria
March 12, 2020
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-PP-13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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