NCT05756140

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

February 16, 2023

Last Update Submit

January 22, 2024

Conditions

Keywords

Geriatric surgeryPain assessmentFacial diagnosis system

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 months

Secondary Outcomes (1)

  • Machine learning will be provided using a computer-assisted facial expression recognition system.

    12 months

Study Arms (1)

Patients Group

Geriatric patients in the postoperative period hospitalized in surgical wards

Other: No intervention

Interventions

No Control

Patients Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

The research sample will consist of geriatric patients aged 65 and over who were hospitalized in the post-operative general surgery service.

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Ataturk State Hospital

Zonguldak, Centre, 67100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Kur Alkant 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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tülin KURT ALKAN, Expert

    https://zonguldakataturkdh.saglik.gov.tr/?_Dil=1

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tülin KURT ALKAN, Expert

CONTACT

Nurten TASDEMİR, Doc. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate in Surgical Nursing Science

Study Record Dates

First Submitted

February 16, 2023

First Posted

March 6, 2023

Study Start

October 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations