Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver (CARE-ICU)

Physiological Changes in Adult Intensive Care Patients Upon Contact With Their Primary Caregiver (CARE-ICU): A Randomized Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Critically Ill Patients
• Intervention / Treatment: Other: Standardized therapeutic physical contact

Detailed Description

This study is a randomized, controlled, parallel-group, double-blind clinical trial designed to evaluate the effect of therapeutic contact provided by the primary caregiver on physiological parameters in adult intensive care unit (ICU) patients. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (therapeutic contact) or the control group (no therapeutic contact) using block randomization generated by an independent external advisor. Allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed, tamper-evident envelopes.

Sample size was calculated for the comparison of means between two independent groups using a 95% confidence level (α = 0.05), 80% statistical power (β = 0.20), a standard deviation of 7.6, and a minimum clinically meaningful difference of 5 units. The estimated sample size was 36 participants per group. After adjustment for an anticipated 10% attrition rate, a total of 80 participants (40 per group) will be enrolled.

Physiological outcomes include heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, oxygen saturation, and body temperature. Measurements will be obtained using a bedside multiparameter monitor and recorded on a standardized physiological data collection form. Equipment calibration will be verified before each measurement. Outcomes will be assessed 10 minutes before the caregiver visit, 10 minutes after the start of the visit, and 10 minutes after completion of the visit.

Changes in physiological outcomes will be calculated as the difference between baseline measurements and subsequent assessments. Data analysis will be performed using IBM SPSS Statistics Version 29.0 (IBM Corp., Armonk, NY, USA). Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, according to data distribution. Categorical variables will be summarized using frequencies and percentages. Normality will be evaluated using the Kolmogorov-Smirnov test. For each physiological outcome, change scores will be calculated by subtracting baseline values from measurements obtained during and after the caregiver visit. Mean changes between the intervention and control groups will be compared using the independent-samples t-test or the Mann-Whitney U test, as appropriate. Effect sizes will be estimated using Cohen's d. Statistical significance will be established at p < 0.05. The study was approved by the Research Ethics Committee of the Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas". The trial will be conducted in accordance with the Declaration of Helsinki and applicable Mexican regulations governing health research. Written informed consent will be obtained from all participants or their legally authorized representatives before enrollment. Adverse events will be documented and reported to the institutional ethics committee and ClinicalTrials.gov according to applicable regulatory requirements.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabel Álvarez-Solorza, Dr.; Phone Number: 8038 +52 1 7222231161; Email: ialvarezs@uaemex.mx

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14080
      • Recruiting
      • Investigación del Instituto Nacional de Enfermedades Respiratorias
      • Contact: Anely González-Colín, BSN; Phone Number: +52 1 5554871700; Email: angonzalezc002@uaemex.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Therapeutic physical contact provided by their primary caregiver	Other: 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.; Other Names: Physical contact
No Intervention: Standard Care Without Therapeutic Contact; Standard intensive care unit care without the standardized therapeutic physical contact intervention provided by the primary caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.
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.	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.
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.	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.
Change in Body Temperature	Body temperature, defined as the degree of body heat expressed in degrees Celsius (°C), measured in the axillary region using a temperature probe connected to a bedside multiparameter monitor.	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.

Collaborators and Investigators

• Sponsor: Universidad Autonoma del Estado de Mexico
• Investigators: Principal Investigator: Isabel Álvarez-Solorza, RN, PhD, Universidad Autonoma del Estado de Mexico

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Critical Illness; Blood Pressure; Heart Rate; Respiratory Rate; Therapeutic Touch; Patient-Centered Care; Critical Care Nursing; Oxygen Saturation; Physiological Parameters; Critically Ill Patients; Primary Caregiver; Physiological Response; Family Caregive; Physical Contact; Human Touch
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: C23-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) may be made available upon reasonable request to the principal investigator, subject to approval by the research team and ethics committee and in accordance with applicable regulation
• IPD Sharing Time Frame: Beginning after publication of the primary study results with no predetermined end date.
• IPD Sharing Access Criteria: De-identified individual participant data (IPD) and supporting documents will be available upon reasonable request to the principal investigator. Access will be granted to researchers with a methodologically sound research proposal following review and approval by the research team and in accordance with ethical and institutional requirements. Data will be shared in a secure manner and only for approved research purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No