Assessment of Postoperative Pain in Children With Facial Expression Analysis

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345275
• Other study ID #: 517517517
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• The facial expressions analyzed
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.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	pain assessment of children by machine	machine-estimated pain severity score from facial expression analysis.	up to the first 36 hours.