PainNCT05756140
Efficiency of Facial Expression Diagnostic System in Pain Assessment After Geriatric Surgery
An observational study of Pain and Aging Problems, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
By integrating the methods used in the assessment of pain in geriatric surgery patients with literature, theory and research, this study aims to: evaluate the effectiveness of the facial diagnosis system in the evaluation of pain after geriatric surgery. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Aging Problems
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Jun 2024
- How long will I take part?
- 1 Year
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The research sample will consist of geriatric patients aged 65 and over who were hospitalized in the post-operative general surgery service.
Who may be able to join
- The patient is 65 years or older,
- According to the American Society of Anesthesiologists (ASA) classification; Being in class -II and III; ASA II: Patient with mild systemic disease, ASA III: Patient with severe systemic disease but not affecting activities of daily living.
- Willingness to participate in the research,
- The patient is awake and oriented after the surgery,
- The patient is not discharged within the first 24 hours after the operation,
Who cannot join
- Not being willing to participate in the research,
- The presence of any facial anomalies that may change the facial expression analysis of the patient,
- The patient's regular use of opiates in the last 6 months,
- The patient has undergone surgical intervention that requires not being in the prone or semifowler position,
- The patient is not awake and oriented after the surgery,
- Discharge of the patient within the first 24 hours after surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zonguldak Ataturk State Hospital
Zonguldak, Centre, 67100
Hasan TOSUN, +90 (372) 252 19 00
About this study
By integrating the methods used in the assessment of pain in geriatric surgery patients with literature, theory and research, this study aims to: evaluate the effectiveness of the facial diagnosis system in the evaluation of pain after geriatric surgery.
The research hypotheses are as follows:
Read more
H1: In the evaluation of pain after geriatric surgery, there is a concordance between the pain score evaluated by the patient and the pain score obtained from facial expression diagnostic system analysis.
H1: In the evaluation of pain after geriatric surgery, there is a correlation between the pain score evaluated by the nurse and the pain score obtained from the analysis of the facial expression diagnosis system.
H1: In the evaluation of pain after geriatric surgery, there is a correlation between the pain score evaluated by the patient and the pain score evaluated by the nurse.
Read the detailed description
By integrating the methods used in the assessment of pain in geriatric surgery patients with literature, theory and research, this study aims to: evaluate the effectiveness of the facial diagnosis system in the evaluation of pain after geriatric surgery.
The number of patients in the groups will be analyzed based on one of the studies to be used in the study. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size is accepted as 0.8, it was seen that at least 68 patients would be sufficient for 80% power. In this way, the criteria sampling method will be used. Anticipated duration is one year.
The inclusion criteria of the patients in the study are as follows:
- The patient is 65 years or older,
- According to the American Society of Anesthesiologists (ASA) classification; Being in class II and III; ASA II: Patient with mild systemic disease, ASA III: Patient with severe systemic disease but not affecting activities of daily living.
- Willingness to participate in the research,
- The patient is awake and oriented after the surgery,
- The patient is not discharged within the first 24 hours after the operation,
Data collecting:
- An informed consent form will be obtained from patients over 65 years of age in the postoperative period who agreed to participate in the study.
- Then, the Sociodemographic Data Collection Form created by the researcher will be filled. Sociodemographic form; patient's age, gender, presence of chronic disease, history of surgery, clinical diagnosis of the patient, the patient's surgery, anesthesia during the operation, the patient's ASA score, the nurse's age, the nurse's gender, the nurse's education level, the nurse's clinical experience, the severity of pain felt by the elderly adult patient.
- After the surgery, when the patient comes to the service and 1 hour after coming to the service, the 3rd and later stages will be repeated. In other words, the patient's pain will be evaluated 2 times in total. The patient and nurse will then be asked to give patient a pain score. Two scales will be used in pain assessment. These are Wong Baker Faces Pain Scale and Numerical Rating Scale.Wong Baker Faces Pain Scale: It consists of 6 different facial expressions, starting with a smiling face and ending with a crying face. Numerical Rating Scale: Patients are asked to draw a number from 0 to 10, 0 to 20, or 0 to 100 that best fits pain intensity. Zero usually indicates "no pain", while the upper limit represents "unbearable pain".
- And the patient's 30-second facial expression will be recorded with a video camera.
- This video recording and the score given by the patient will be uploaded to the computer and the pain score.
- The resulting value will be compared with the value given by the nurses.
- Conditions
- Pain, Aging Problems
- Being tested
- No intervention
- Keywords
- Geriatric surgery, Pain assessment, Facial diagnosis system
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Control
| Study group | Role | What they receive |
|---|---|---|
| Patients Group | Geriatric patients in the postoperative period hospitalized in surgical wards Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the average scores from the "Wong Baker Facial Pain Scale"
Wong Baker Facial Pain Scale: It consists of 6 different facial expressions, starting with a smiling face and ending with a crying face. The patient and the nurse will be asked to give a pain score to the patient when immediately after the patient comes from the surgery and 1 hour after coming to the service.
Measured: 6 months
Determination of the average scores from the "Numerical Rating Scale"
Numerical Rating Scale: Patients are asked to draw a number from 0 to 10, 0 to 20, or 0 to 100 that best fits pain intensity. Zero usually indicates "no pain", while the upper limit represents "unbearable pain". The patient and the nurse will be asked to give a pain score to the patient when immediately after the patient comes from the surgery and 1 hour after coming to the service.
Measured: 6 months
Secondary outcomes (1)
Machine learning will be provided using a computer-assisted facial expression recognition system.
The 30-second facial expression of the patient is recorded with a video camera immediately after the patient leaves the surgery and comes to the service and 1 hour after coming to the service. With this video recording and the score given by the patient, the pain score will be uploaded to the computer. The obtained value will be compared with the value given by the nurses.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülin KURT ALKAN, Zonguldak Bulent Ecevit University
- Investigators
- Tülin KURT ALKAN, Expert, Principal investigator, https://zonguldakataturkdh.saglik.gov.tr/?_Dil=1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756140
- Sponsor's protocol ID
- 2022-16-09
- Status last verified
- Jan 2024
- First submitted
- 16 Feb 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurt Alkan T, Tasdemir N. Testing Machine Learning-Based Pain Assessment for Postoperative Geriatric Patients. Comput Inform Nurs. 2025 Nov 1;43(11):e01248. doi: 10.1097/CIN.0000000000001248.
PubMed 39761361
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Facial Expression Diagnostic System in Pain Assessment After Geriatric Surgery
- ClinicalTrials.gov ID
- NCT05756140
- Acronym / sponsor ID
- 2022-16-09
- Conditions
- Pain, Aging Problems
- Keywords
- Geriatric surgery, Pain assessment, Facial diagnosis system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Mar 2023 (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.
By integrating the methods used in the assessment of pain in geriatric surgery patients with literature, theory and research, this study aims to: evaluate the effectiveness of the facial diagnosis system in the evaluation of pain after geriatric surgery.
The research hypotheses are as follows:
H1: In the evaluation of pain after geriatric surgery, there is a concordance between the pain score evaluated by the patient and the pain score obtained from facial expression diagnostic system analysis.
H1: In the evaluation of pain after geriatric surgery, there is a correlation between the pain score evaluated by the nurse and the pain score obtained from the analysis of the facial expression diagnosis system.
H1: In the evaluation of pain after geriatric surgery, there is a correlation between the pain score evaluated by the patient and the pain score evaluated by the nurse.
Detailed description
By integrating the methods used in the assessment of pain in geriatric surgery patients with literature, theory and research, this study aims to: evaluate the effectiveness of the facial diagnosis system in the evaluation of pain after geriatric surgery.
The number of patients in the groups will be analyzed based on one of the studies to be used in the study. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size is accepted as 0.8, it was seen that at least 68 patients would be sufficient for 80% power. In this way, the criteria sampling method will be used. Anticipated duration is one year.
The inclusion criteria of the patients in the study are as follows:
- The patient is 65 years or older,
- According to the American Society of Anesthesiologists (ASA) classification; Being in class II and III; ASA II: Patient with mild systemic disease, ASA III: Patient with severe systemic disease but not affecting activities of daily living.
- Willingness to participate in the research,
- The patient is awake and oriented after the surgery,
- The patient is not discharged within the first 24 hours after the operation,
Data collecting:
- An informed consent form will be obtained from patients over 65 years of age in the postoperative period who agreed to participate in the study.
- Then, the Sociodemographic Data Collection Form created by the researcher will be filled. Sociodemographic form; patient's age, gender, presence of chronic disease, history of surgery, clinical diagnosis of the patient, the patient's surgery, anesthesia during the operation, the patient's ASA score, the nurse's age, the nurse's gender, the nurse's education level, the nurse's clinical experience, the severity of pain felt by the elderly adult patient.
- After the surgery, when the patient comes to the service and 1 hour after coming to the service, the 3rd and later stages will be repeated. In other words, the patient's pain will be evaluated 2 times in total. The patient and nurse will then be asked to give patient a pain score. Two scales will be used in pain assessment. These are Wong Baker Faces Pain Scale and Numerical Rating Scale.Wong Baker Faces Pain Scale: It consists of 6 different facial expressions, starting with a smiling face and ending with a crying face. Numerical Rating Scale: Patients are asked to draw a number from 0 to 10, 0 to 20, or 0 to 100 that best fits pain intensity. Zero usually indicates "no pain", while the upper limit represents "unbearable pain".
- And the patient's 30-second facial expression will be recorded with a video camera.
- This video recording and the score given by the patient will be uploaded to the computer and the pain score.
- The resulting value will be compared with the value given by the nurses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Group | – | Other: No interventionGeriatric patients in the postoperative period hospitalized in surgical wards |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The research sample will consist of geriatric patients aged 65 and over who were hospitalized in the post-operative general surgery service.
Key inclusion criteria (5 listed)
- The patient is 65 years or older,
- According to the American Society of Anesthesiologists (ASA) classification; Being in class -II and III; ASA II: Patient with mild systemic disease, ASA III: Patient with severe systemic disease but not affecting activities of daily living.
- Willingness to participate in the research,
- The patient is awake and oriented after the surgery,
- The patient is not discharged within the first 24 hours after the operation,
Key exclusion criteria (6 listed)
- Not being willing to participate in the research,
- The presence of any facial anomalies that may change the facial expression analysis of the patient,
- The patient's regular use of opiates in the last 6 months,
- The patient has undergone surgical intervention that requires not being in the prone or semifowler position,
- The patient is not awake and oriented after the surgery,
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 |
|---|---|---|
| No interventionNo Control | Other | Patients Group |
Primary outcome
Determination of the average scores from the "Wong Baker Facial Pain Scale"
Time frame: 6 months
Wong Baker Facial Pain Scale: It consists of 6 different facial expressions, starting with a smiling face and ending with a crying face. The patient and the nurse will be asked to give a pain score to the patient when immediately after the patient comes from the surgery and 1 hour after coming to the service.
Determination of the average scores from the "Numerical Rating Scale"
Time frame: 6 months
Numerical Rating Scale: Patients are asked to draw a number from 0 to 10, 0 to 20, or 0 to 100 that best fits pain intensity. Zero usually indicates "no pain", while the upper limit represents "unbearable pain". The patient and the nurse will be asked to give a pain score to the patient when immediately after the patient comes from the surgery and 1 hour after coming to the service.
1 secondary outcome
Machine learning will be provided using a computer-assisted facial expression recognition system.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 39761361Kurt Alkan T, Tasdemir N. Testing Machine Learning-Based Pain Assessment for Postoperative Geriatric Patients. Comput Inform Nurs. 2025 Nov 1;43(11):e01248. doi: 10.1097/CIN.0000000000001248.
- Individual participant dataSharing planned: No
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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.
Tülin KURT ALKAN, Expert principal investigator
https://zonguldakataturkdh.saglik.gov.tr/?_Dil=1
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 and Aging Problems, run by Zonguldak Bulent Ecevit 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tülin KURT ALKAN, Expert (+905393711902, tulinkurt0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the average scores from the "Wong Baker Facial Pain Scale" (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756140, which also lists 1 linked publication.
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 23 Jan 2024.