About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Standardized therapeutic physical contact
Other interventionDuring the pre-visit phase (30 minutes), caregivers will receive information about the study, patient's condition, infection control procedures, and training on the standardized contact protocol. During the visit phase (20 min), the caregiver will greet the patient in a customary manner (1 min); provide a gentle massage to the dorsal surface of the hand while discussing positive events of the day (6 min); gently touch the patient's forehead with the fingertips while recalling pleasant memories (3 min); gently massage the patient's cheek using the fingertips while providing encouraging and positive messages (3 minutes); massage the palm of the patient's hand using circular movements while discussing goals to be achieved after hospital discharge (4 min); and holding the patient's hand and expressing wishes for recovery and discharge (3 min). Following the visit, caregivers will be given the opportunity to share observations, comments, and feedback regarding the intervention experience.
Treatment groups
Trial outcomes
Primary outcomes
Change in Heart Rate
Heart rate, expressed as beats per minute (bpm), measured using a bedside multiparameter monitor through cutaneous electrodes. Changes in heart rate will be assessed before, during, and after the intervention.
Secondary outcomes
Change in Systolic Blood Pressure
Systolic blood pressure, defined as the maximum arterial pressure during cardiac contraction, measured in millimeters of mercury (mmHg). Measurements will be obtained using a bedside multiparameter monitor through a blood pressure cuff or arterial line.
Change in Diastolic Blood Pressure
Diastolic blood pressure, defined as the minimum arterial pressure during cardiac relaxation, measured in millimeters of mercury (mmHg). Measurements will be obtained using a bedside multiparameter monitor through a blood pressure cuff or arterial line.
Change in Respiratory Rate
Respiratory rate, defined as the number of breaths per minute (breaths/min), measured using a bedside multiparameter monitor through cutaneous electrodes.
Change in Oxygen Saturation
Oxygen saturation, defined as the percentage of arterial hemoglobin saturated with oxygen (SpO₂), measured using a pulse oximeter placed on the patient's finger under conditions free of movement interference.
Sponsors and contacts
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