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Completed

NCT Number: NCT05345275

Assessment of Postoperative Pain in Children With 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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Uludağ University

Bursa, 16059, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The facial expressions analyzed

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. pain assessment of children by machine

    Time frame: up to the first 36 hours.

    machine-estimated pain severity score from facial expression analysis.

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

Assessment of Postoperative Pain in Children With Computer Assisted Facial Expression Analysis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2022
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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