Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06485856

Assessment of Pain Using a Facial Movement Diagnostic System in Intensive Care Patients Who Cannot Verbally Communicate

Led by Fatmagül Üstünel · Updated on 2024-07-03

46

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

F

Fatmagül Üstünel

Lead Sponsor

C

Cukurova University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pain is a complex and subjective experience especially challenging to assess in patients who are conscious but unable to communicate verbally, such as those in intensive care. This research aims to evaluate a pain diagnostic system that measures facial movements using the Facial Action Coding system to objectively assess pain levels in surgical patients who cannot clearly express their pain. The study addresses concerns that healthcare professionals may underestimate pain in these patients and seeks to improve pain assessment accuracy. Participants will be monitored during four different procedural events while conscious in intensive care. During each procedure, twelve pictures of the patient's face will be taken over one minute. After each procedure, patients will rate their pain on a numerical scale from 0 (no pain) to 10 (severe pain). Expert nurses will also assess the patients' pain by evaluating their facial expressions in the pictures, and the Facial Action Coding system will independently score the pain from the images. These assessments will be compared to determine which method aligns closest with the patients' own pain ratings. Participants will undergo pain assessments during intensive care procedures, including facial imaging and self-reported pain scores. The study will analyze these data alongside expert nurse evaluations and computerized facial coding results. The main outcome is pain diagnosis accuracy during each procedure in the intensive care unit. The study involves conscious patients aged 18 and older who cannot communicate verbally but have a Glasgow Coma Score between 13 and 15. The total participation duration depends on the number of procedures each patient undergoes.

CONDITIONS

Brief Title

ASSESSMENT OF PAIN USING A PAIN DIAGNOSTIC SYSTEM THAT MEASURS FACIAL MOVEMENT USING

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years and older
  • Patients with intubation or tracheostomy
  • Conscious but unable to communicate verbally
  • Glasgow Coma Score between 13 and 15
  • Patients who agree to participate in the study
Not Eligible

You will not qualify if you...

  • Any facial abnormality affecting facial expression analysis (e.g., facial paralysis, Poland-Mobius syndrome)
  • Neurological or mental disorders
  • History of chronic pain
  • Conditions requiring constant prone position (e.g., Pilonidal Sinus, ARDS)
  • Inability to speak the same language as healthcare professionals

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - During 12 procedural procedures

Participants undergo pain assessment during procedural procedures using facial movement analysis and expert evaluations.

4 procedural sessions with pictures taken 12 times each

Trial Site Locations

Total: 1 location

1

Cukurova University

Adana, Turkey (Türkiye)

Actively Recruiting

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Research Team

F

Fatmagül Üstünel, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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