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

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

      • Bursa, Turkey, 16059
        • Bursa Uludag University

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
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.
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.

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
WBS scales were used for pain assessment of children, mothers, nurses, and observers.
after surgery in the first 12 hours
the first observation on pain assessment of children by human
Time Frame: after surgery in the first 12 hours
VAS scales were used for pain assessment of children, mothers, nurses, and observers.
after surgery in the first 12 hours
the second observation on pain assessment of children by human
Time Frame: after surgery 24.-36. range hours
VAS scales were used for pain assessment of children, mothers, nurses, and observers.
after surgery 24.-36. range hours
the second observation on pain assessment of children by human
Time Frame: after surgery 24.-36. range hours
WBS scales were used for pain assessment of children, mothers, nurses, and observers.
after surgery 24.-36. range hours
child's facial expressions
Time Frame: up to the first 36 hours.
Facial action units associated with pain were used from the camera recordings of the child's facial expressions.
up to the first 36 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain assessment of children by machine
Time Frame: up to the first 36 hours.
machine-estimated pain severity score from facial expression analysis.
up to the first 36 hours.

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)

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

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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