- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467551
Turkish Validity and Reliability of the Behavioral Indicators of Pain Scale(ESCID)
Reliability and Validity of the Turkish Version of the Behavioral Indicators of Pain Scale in Mechanically Ventilated Intensive Care Unit Patients
A significant proportion of patients hospitalized in intensive care units (ICUs) require mechanical ventilation, and the treatments applied during this process may cause pain. Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Although it is associated with delirium and agitation, pain is often an overlooked symptom in ICU patients, and a large proportion of mechanically ventilated patients continue to experience moderate to severe pain. The most common type of pain in critically ill patients is nociceptive pain, which may result from invasive procedures such as tracheal intubation, catheter insertion, aspiration, wound care, and patient repositioning. Additionally, the noisy and unfamiliar ICU environment and patients' inability to express themselves may further increase the perception of pain.
Regular assessment of pain is associated with many positive outcomes, including more effective pain management, appropriate use of analgesic and sedative medications, and shorter duration of mechanical ventilation and ICU stay. Although self-reporting of pain is considered the gold standard, many patients receiving mechanical ventilation are unable to communicate their pain. Therefore, various behavioral pain assessment scales are used to evaluate pain in ICU patients. One of these tools is the Behavioral Indicators of Pain Scale (Escala de Conductas Indicadoras de Dolor - ESCID), which was developed to assess pain in critically ill adult patients receiving mechanical ventilation who are unable to communicate. However, a Turkish version of this scale has not yet been developed. Therefore, the aim of this study is to translate the ESCID scale into Turkish, perform its cultural adaptation, and test the validity and reliability of the Turkish version.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Burak Uyaroğlu, Asst Prof
- Phone Number: +905396545352
- Email: mburakuyaroglu@gmail.com
Study Contact Backup
- Name: Esra Pehlivan, Prof Dr
- Email: m.uyaroglu1@gmail.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Goztepe Prof Dr Suleyman Yalcin City Hospital
-
Contact:
- Mehmet B Uyaroglu, Asst. Prof
- Phone Number: +905396545352
- Email: m.uyaroglu1@gmail.com
-
Contact:
- Hasan Kocoglu, Prof. Dr.
- Email: hasankocoglu@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 18 years and older
- Patients who are intubated, receiving mechanical ventilation, and unable to establish verbal communication (Glasgow Coma Scale score <14)
- Patients who have been hospitalized in the intensive care unit for at least 24 hours
Exclusion Criteria:
- Presence of postoperative complications
- Hemodynamic instability
- History of diagnosed cognitive or psychiatric disorders
- History of epilepsy or use of neuromuscular blocking agents
- History of spinal cord injury affecting motor function of all four extremities
- Individuals with a Richmond Agitation-Sedation Scale (RASS) score of -5 (unresponsive)
- Cases with suspected brain death
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: Single Group
The ESCID scale will be applied to a sample of 50 patients.
|
ESCID scale will be applied to 50 intubated ICU patients to assess pain through behavioral indicators. The study evaluate the Turkish validity and reliability of the ESCID scale. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Behavioral Indicators of Pain Scale (ESCID)
Time Frame: 5 month
|
ESCID evaluates pain based on observable behavioral indicators, including facial expression, calmness, muscle tone, comfort level, and adaptation to mechanical ventilation.
Each item is scored from 0 to 2, and the total score reflects the patient's level of pain.
The application of ESCID allows systematic and objective pain assessment in patients who cannot self-report their pain.
|
5 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet Burak Uyaroğlu, Asst Prof, Fenerbahçe University
- Study Director: Esra Pehlivan, Prof Dr, Saglik Bilimleri University
- Study Chair: Hasan Kocoglu, Prof Dr, Medeniyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- Fenerbahce
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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