Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorUniversidad Autonoma del Estado de Mexico

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Standardized therapeutic physical contact

    Other intervention

    During 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

80 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Standard Care Without Therapeutic ContactNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.

Secondary outcomes

1

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.

Time frame
10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.
2

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.

Time frame
10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.
3

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.

Time frame
10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.
4

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.

Time frame
10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.