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NCT07761364
Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver
Conditions: Critical Illness, Critically Ill Patients
Sex: All
Ages: 18 Years – 59 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Universidad Autonoma del Estado de Mexico
Location: Investigación del Instituto Nacional de Enfermedades Respiratorias Mexico City Mexico City
Summary
Patients admitted to intensive care units are exposed to multiple environmental and clinical factors that may affect their physiological responses. This randomized controlled trial aims to evaluate the effect of physical contact with the primary caregiver on physiological parameters in adult patients hospitalized in an intensive care unit.
Eligibility Criteria
Inclusion Criteria
Patient Criteria:
* Adults aged 18 years or older.
* Admission to the intensive care unit (ICU) for 24 to 48 hours.
* Richmond Agitation-Sedation Scale (RASS) score between -3 and -1 or between 0 and +3.
* Glasgow Coma Scale score greater than 13.
Primary Caregiver Criteria:
* Identified as the patient's primary caregiver.
* Willing and able to participate in the study.
* Provides written informed consent prior to study participation.
Exclusion Criteria
Patient Criteria:
* Diagnosis of a neurological disorder (e.g., cerebrovascular disease or stroke).
* Multiple organ dysfunction syndrome (MODS).
* Unstable or difficult-to-control cardiac arrhythmias.
* Fever (body temperature ≥ 37.5°C) at the time of assessment.
* Hypertension (blood pressure ≥ 130/80 mmHg) at the time of assessment.
Primary Caregiver Criteria:
\- Unable to be present to perform the intervention according to the study protocol.
Source: ClinicalTrials.gov (NCT07761364). StuddyBuddy aggregates publicly available trial information.