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Clinical Trials in Mexico / NCT07761364
Recruiting Not applicable

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

NCT07761364 · tracked via the Priya Life Science Mexico tracker
Sponsor
Universidad Autonoma del Estado de Mexico
Phase
Not applicable
Started
2026-08-01
Last updated
2026-08-12

Condition(s) studied

Critical IllnessCritically Ill Patients

Investigational drug(s) / intervention(s)

Standardized therapeutic physical contact

Standardized therapeutic physical contact: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Heart Rate — 10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.
    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.

Trial sites (1)

FacilityCityRegionStatus
Investigación del Instituto Nacional de Enfermedades Respiratorias Mexico City Mexico City Recruiting

More Universidad Autonoma del Estado de Mexico trials in Mexico

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The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07761364 on ClinicalTrials.gov ↗ ← All trials in Mexico