Pain, PostoperativeNCT05345275
Assessment of Postoperative Pain in Children With Facial Expression Analysis
An observational study of Pain, Postoperative, run by Uludag University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- The facial expressions analyzed
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study sample consisted of 7-18 age group patients who underwent surgery in the pediatric surgery clinic of a university hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain, Postoperative
- Being tested
- The facial expressions analyzed
- Keywords
- children, facial expression analysis, machine learning, pain assessment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The facial expressions analyzedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The facial expressions analyzed |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first observation on pain assessment of children by human
WBS scales were used for pain assessment of children, mothers, nurses, and observers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to the first 36 hours.
Secondary outcomes (1)
pain assessment of children by machine
machine-estimated pain severity score from facial expression analysis.
Measured: up to the first 36 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Nov 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Irem Aydin, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345275
- Sponsor's protocol ID
- 517517517
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain in Children With Computer Assisted Facial Expression Analysis
- ClinicalTrials.gov ID
- NCT05345275
- Acronym / sponsor ID
- 517517517
- Conditions
- Pain, Postoperative
- Keywords
- children, facial expression analysis, machine learning, pain assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pain assessments | – | Other: The facial expressions analyzedIn 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study sample consisted of 7-18 age group patients who underwent surgery in the pediatric surgery clinic of a university hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The facial expressions analyzedThe 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. | Other | pain assessments |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
pain assessment of children by machine
Time frame: up to the first 36 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the first observation on pain assessment of children by human (time frame: after surgery in the first 12 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.