- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05345275
Assessment of Postoperative Pain in Children With Facial Expression Analysis
April 20, 2022 updated by: Ayla Irem Aydin, Uludag University
Assessment of Postoperative Pain in Children With Computer Assisted Facial Expression Analysis
The present study was conducted to evaluate the use of computer-aided facial expression analysis to assess postoperative pain in children.
The study population consisted of patients in the age group of 7-18 years who underwent surgery at Bursa Uludağ University Faculty of Medicine Health Application and Research Hospital Pediatric Surgery Clinic between November 2019 and June 2021.
The sample of the study consisted of total 83 children who agreed to participate in the study and who met the sample selection criteria.
Data were collected by the researcher using the Wong Baker Faces (WBS) pain rating scale and Visual Analog Scale (VAS).
Data were collected from the child, mother, nurse, and one external observer.
Facial action units associated with pain were used for machine estimation.
OpenFace was used to analyze the child's facial action units and Python was used for machine learning algorithms.
Intraclass correlation coefficient, Kappa coefficient, and linear regression analysis were used for statistical analysis of the data.
The pain score predicted by the machine and the pain score assessments of the child, mother, nurse, and observer were compared.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
83
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
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Bursa, Turkey, 16059
- Bursa Uludag University
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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
7 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study sample consisted of 7-18 age group patients who underwent surgery in the pediatric surgery clinic of a university hospital.
Description
Inclusion Criteria:
- The patient is awake and oriented after the surgery,
- The patient must be within the first 12 hours after the operation and not be discharged before the first 36 hours after the operation,
- The patient is between the ages of 7-18,
- It is the mother's staying with the patient as a companion.
Exclusion Criteria:
- Presence of any facial anomalies that may alter facial expression analysis,
- The patient has neurological and mental disorders,
- Having regular opiate use in the last 6 months,
- These are surgical procedures that require the patient to be in a prone position.
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 |
|---|---|
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pain assessments
In the study, primarily the pain assessment data of children were collected.
In these pain assessments, assessments of the child, mother, nurse and an independent observer were taken.
Simultaneously, a video recording of the child's facial expressions was made.
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The facial expressions associated with pain were analyzed by the researchers in the OpenFace program.
The patient's pain scores were estimated in the Python program by combining the numerical outputs of facial expression analyses with machine learning algorithms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the first observation on pain assessment of children by human
Time Frame: after surgery in the first 12 hours
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WBS scales were used for pain assessment of children, mothers, nurses, and observers.
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after surgery in the first 12 hours
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the first observation on pain assessment of children by human
Time Frame: after surgery in the first 12 hours
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VAS scales were used for pain assessment of children, mothers, nurses, and observers.
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after surgery in the first 12 hours
|
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the second observation on pain assessment of children by human
Time Frame: after surgery 24.-36. range hours
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VAS scales were used for pain assessment of children, mothers, nurses, and observers.
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after surgery 24.-36. range hours
|
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the second observation on pain assessment of children by human
Time Frame: after surgery 24.-36. range hours
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WBS scales were used for pain assessment of children, mothers, nurses, and observers.
|
after surgery 24.-36. range hours
|
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child's facial expressions
Time Frame: up to the first 36 hours.
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Facial action units associated with pain were used from the camera recordings of the child's facial expressions.
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up to the first 36 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain assessment of children by machine
Time Frame: up to the first 36 hours.
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machine-estimated pain severity score from facial expression analysis.
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up to the first 36 hours.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 1, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
March 24, 2022
First Submitted That Met QC Criteria
April 20, 2022
First Posted (Actual)
April 25, 2022
Study Record Updates
Last Update Posted (Actual)
April 25, 2022
Last Update Submitted That Met QC Criteria
April 20, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 517517517
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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