NCT05345275

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

March 24, 2022

Last Update Submit

April 20, 2022

Conditions

Keywords

childrenfacial expression analysismachine learningpain assessment

Outcome Measures

Primary Outcomes (5)

  • the first observation on pain assessment of children by human

    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

    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

    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

    WBS scales were used for pain assessment of children, mothers, nurses, and observers.

    after surgery 24.-36. range hours

  • child's facial expressions

    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 Outcomes (1)

  • pain assessment of children by machine

    up to the first 36 hours.

Study Arms (1)

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.

Other: The facial expressions analyzed

Interventions

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.

pain assessments

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludağ University

Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD, RN

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 25, 2022

Study Start

November 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations