NursingNCT06485856
ASSESSMENT OF PAIN USING A PAIN DIAGNOSTIC SYSTEM THAT MEASURS FACIAL MOVEMENT USING
A study testing Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in people with Nursing and Pain Assessment, run by Fatmagül Üstünel at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing, Pain Assessment, Critical Care
- What is being tested?
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University
Adana
Cukurova University
About this study
Official title: 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.
- Conditions
- Nursing, Pain Assessment, Critical Care, Technology, Facial Recognition
- Being tested
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Keywords
- Nurse, Pain assessment, Intensive care, Facial diagnosis, Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Behavioural
Evaluation of the pain level of patients who are followed in intensive care and cannot speak during the procedural procedure with 3 different methods.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Other | 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. Receives: Behavioral: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain diagnosis in intensive care patients
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start15 May 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatmagül Üstünel
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University
- Responsible party
- Sponsor-investigator, Fatmagül Üstünel, Cukurova University
- Investigators
- Cukurova University Cukurova University, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485856
- Sponsor's protocol ID
- FU312
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cukurova University
- ClinicalTrials.gov ID
- NCT06485856
- Acronym / sponsor ID
- FU312
- Conditions
- Nursing, Pain Assessment, Critical Care, Technology, Facial Recognition
- Keywords
- Nurse, Pain assessment, Intensive care, Facial diagnosis, Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fatmagül ÜstünelUniversity, hospital or other
- Collaborators
- Cukurova University
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Other | Behavioral: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0During 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Evaluation of the pain level of patients who are followed in intensive care and cannot speak during the procedural procedure with 3 different methods. | Behavioural | Experimental group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Cukurova University Cukurova University study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in people with Nursing and Pain Assessment, run by Fatmagül Üstünel 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 5 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 3 Jul 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 Fatmagül Üstünel, MSc (05469589973, ela.0808@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 3 Jul 2024.