Clinical Trial: Prevalence and Clustering of Five Common Symptoms (Pain, Thirst, Dyspnea, Anxiety, Sleep Disturbance) in ICU Patients after Elective Surgery or Catheter Intervention: A Prospective Observational Study (Japan)

Tokyo, May 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061686) titled 'Prevalence and Clustering of Five Common Symptoms (Pain, Thirst, Dyspnea, Anxiety, Sleep Disturbance) in ICU Patients after Elective Surgery or Catheter Intervention: A Prospective Observational Study' on May 26.

Study Type: Observational

Primary Sponsor: Institute - Hospital of the University of Occupational and Environmental Health

Condition: Condition - ICU Patients after Elective Surgery or Catheter Intervention Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to determine the prevalence and severity of five symptoms (pain, thirst, dyspnea, anxiety, and sleep disturbance) in ICU patients after elective surgery or catheter intervention, and to explore factors associated with symptom occurrence (e.g., age, type of surgery). Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients admitted to the ICU following elective surgery or catheter intervention who meet all of the following inclusion criteria and none of the exclusion criteria. Inclusion Criteria: Patients capable of self-reporting at the time of assessment, as defined by: A Richmond Agitation-Sedation Scale (RASS) score between -1 and +1. For non-intubated patients: A Glasgow Coma Scale (GCS) score of 14 to 15. For intubated/non-verbal patients: A GCS score of E4VTM6, with intact orientation and the ability to communicate. Key exclusion criteria - Patients with cognitive impairment (i.e., a documented diagnosis of dementia). Patients who screen positive for delirium at the time of assessment (CAM-ICU positive). Patients who have difficulty communicating in Japanese. Patients who refuse or are unable to provide informed consent. Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 12 Day Date of IRB - 2026 Year 05 Month 19 Day Anticipated trial start date - 2026 Year 05 Month 26 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070585

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