NCT06485856

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 6, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

NursePain assessmentIntensive careFacial diagnosisTechnology

Outcome Measures

Primary Outcomes (1)

  • Pain diagnosis in intensive care patients

    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.

Study Arms (1)

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.

Behavioral: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Interventions

Evaluation of the pain level of patients who are followed in intensive care and cannot speak during the procedural procedure with 3 different methods.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

RECRUITING

Study Officials

  • Cukurova University Cukurova University

    Cukurova University

    STUDY DIRECTOR

Central Study Contacts

Fatmagül Üstünel, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2024

First Posted

July 3, 2024

Study Start

May 15, 2024

Primary Completion

October 15, 2024

Study Completion

December 15, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Locations