- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06485856
ASSESSMENT OF PAIN USING A PAIN DIAGNOSTIC SYSTEM THAT MEASURS FACIAL MOVEMENT USING
Cukurova University
Pain is a subjectively difficult, abstract and comprehensive concept that is at the core of the whole study, emerging in relation to various advancements, and detailed description. For non-controlling, stress-free, stress-or-thickness training for thromboembolic, pulmonary and other organ modalities, re-admission from discharge, thromboembolic, pulmonary and other reasons.
The scales of use in the assessment of pain in the conscious surgical patient who cannot communicate verbally, into the pain, are physically subjective. Ekman and Friesen are planning the movements of their muscles to be performed by an Action Coding process that could be experienced in 1978. system; It has been applied in pain, in the evaluation of pain in the postoperative period and in children, in the new clinical practice, and in the new and clinical practice.
Health professionals may be biased in diagnosing pain, especially in intensive care patients, and may underestimate pain. In the literature, it is seen that the child who is made with pain in his patients in education in the field of medicine is not used in his experiences, similar to the pain that measures the tastes of the faces of the single scales. In this context, standardized, continuous, objective and scalable pain measures indicate the practice environment. The aim of these people is to evaluate the pain in our surgical patients who cannot communicate clearly and clearly with pain diagnosis that measures facial movement.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatmagül Üstünel, MSc
- Phone Number: 05469589973
- Email: ela.0808@hotmail.com
Study Locations
-
-
-
Adana, Turkey
- Recruiting
- Cukurova University
-
Contact:
- Cukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years and over,
- Those with intubation/tracheostomy,
- Conscious, unable to communicate verbally,
- Glaskow coma score 13-15,
- Patients who agreed to participate in the study
Exclusion Criteria:
- Those with any facial abnormality that may alter facial expression analysis (facial paralysis, Poland-mobius syndrome)
- Those with neurological and mental disorders,
- Having a history of chronic pain,
- Those who have a condition that requires them to be in the prone position all the time (Pilonidal Sinus, ARDS, etc.),
- Patients who cannot speak the same language as the healthcare professional
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Experimental group
During the procedural procedures applied to patients who are monitored in intensive care and who are conscious but unable to express themselves verbally, their pictures will be taken 12 times for one minute.
This procedure will be applied to the same patient during 4 different procedures.
After the procedure, the patient will be asked to score his/her pain numerically between 0-10 (0-no pain, 10-severe/unbearable pain).
In addition, the images obtained will be evaluated by three expert nurses and they will be asked to estimate the patient's pain based on their facial expressions.
Meanwhile, the pain assessment based on the patient's pictures will be evaluated numerically between 0-10 by the Facial Action Coding system.
As the final process, all data will be compared and the patient's pain expression will be compared with the Facial Action Coding system and the pain evaluations of the experts.
The assessment closest to the patient's pain expression will be determined.
|
Evaluation of the pain level of patients who are followed in intensive care and cannot speak during the procedural procedure with 3 different methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain diagnosis in intensive care patients
Time Frame: In the intensive care unit, the pain felt by the patient during the procedure will be evaluated. This assessment will be repeated for each patient throughout the 12 procedure procedures performed on the patient.
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
In the intensive care unit, the pain felt by the patient during the procedure will be evaluated. This assessment will be repeated for each patient throughout the 12 procedure procedures performed on the patient.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Cukurova University Cukurova University, Cukurova University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FU312
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.