Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:19 AM
Study NCT ID:
NCT07467551
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkish Validity and Reliability of the Behavioral Indicators of Pain Scale(ESCID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Behavioral Indicators of Pain Scale (ESCID)', 'timeFrame': '5 month', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'intensive care', 'intubation', 'pain'], 'conditions': ['Mechanical Ventilation', 'Pain Perception', 'Intensive Care (ICU)']}, 'descriptionModule': {'briefSummary': "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.\n\nRegular 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 years and older\n* Patients who are intubated, receiving mechanical ventilation, and unable to establish verbal communication (Glasgow Coma Scale score \\<14)\n* Patients who have been hospitalized in the intensive care unit for at least 24 hours\n\nExclusion Criteria:\n\n* Presence of postoperative complications\n* Hemodynamic instability\n* History of diagnosed cognitive or psychiatric disorders\n* History of epilepsy or use of neuromuscular blocking agents\n* History of spinal cord injury affecting motor function of all four extremities\n* Individuals with a Richmond Agitation-Sedation Scale (RASS) score of -5 (unresponsive)\n* Cases with suspected brain death'}, 'identificationModule': {'nctId': 'NCT07467551', 'briefTitle': 'Turkish Validity and Reliability of the Behavioral Indicators of Pain Scale(ESCID)', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Reliability and Validity of the Turkish Version of the Behavioral Indicators of Pain Scale in Mechanically Ventilated Intensive Care Unit Patients', 'orgStudyIdInfo': {'id': 'fenerbahce'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Group', 'description': 'The ESCID scale will be applied to a sample of 50 patients.', 'interventionNames': ['Other: The ESCID scale']}], 'interventions': [{'name': 'The ESCID scale', 'type': 'OTHER', 'description': 'ESCID scale will be applied to 50 intubated ICU patients to assess pain through behavioral indicators.\n\nThe study evaluate the Turkish validity and reliability of the ESCID scale.', 'armGroupLabels': ['Single Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet B Uyaroglu, Asst. Prof', 'role': 'CONTACT', 'email': 'm.uyaroglu1@gmail.com', 'phone': '+905396545352'}, {'name': 'Hasan Kocoglu, Prof. Dr.', 'role': 'CONTACT', 'email': 'hasankocoglu@yahoo.com'}], 'facility': 'Goztepe Prof Dr Suleyman Yalcin City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Mehmet Burak Uyaroğlu, Asst Prof', 'role': 'CONTACT', 'email': 'mburakuyaroglu@gmail.com', 'phone': '+905396545352'}, {'name': 'Esra Pehlivan, Prof Dr', 'role': 'CONTACT', 'email': 'm.uyaroglu1@gmail.com'}], 'overallOfficials': [{'name': 'Mehmet Burak Uyaroğlu, Asst Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fenerbahce University'}, {'name': 'Esra Pehlivan, Prof Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saglik Bilimleri University'}, {'name': 'Hasan Kocoglu, Prof Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Medeniyet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fenerbahce University', 'class': 'OTHER'}, {'name': 'Goztepe Prof Dr Suleyman Yalcın City Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Burak Uyaroğlu', 'investigatorAffiliation': 'Fenerbahce University'}}}}