NCT07467551

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Mar 2026

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

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Jul 2027

Study Start

First participant enrolled

March 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 9, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

mechanical ventilationintensive careintubationpain

Outcome Measures

Primary Outcomes (1)

  • The Behavioral Indicators of Pain Scale (ESCID)

    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

Study Arms (1)

Single Group

OTHER

The ESCID scale will be applied to a sample of 50 patients.

Other: The ESCID scale

Interventions

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.

Single Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehmet Burak Uyaroğlu, Asst Prof

    Fenerbahce University

    PRINCIPAL INVESTIGATOR
  • Esra Pehlivan, Prof Dr

    Saglik Bilimleri University

    STUDY DIRECTOR
  • Hasan Kocoglu, Prof Dr

    Medeniyet University

    STUDY CHAIR

Central Study Contacts

Mehmet Burak Uyaroğlu, Asst Prof

CONTACT

Esra Pehlivan, Prof Dr

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

March 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations