Critical Illness, Critically Ill Patients
Conditions
Keywords
Intensive Care Unit, Critical Illness, Critically Ill Patients, Primary Caregiver, Family Caregive, Therapeutic Touch, Physical Contact, Human Touch, Physiological Parameters, Physiological Response, Heart Rate, Blood Pressure, Respiratory Rate, Oxygen Saturation, Critical Care Nursing, Patient-Centered Care
Brief 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.
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.
Interventions
OTHERStandardized 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.
Sponsors
Universidad Autonoma del Estado de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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. |
| Change in Body Temperature | 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. | 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. |
Countries
Mexico
Contacts
CONTACTIsabel Álvarez-Solorza, Dr.
PRINCIPAL_INVESTIGATORIsabel Álvarez-Solorza, RN, PhD
Universidad Autonoma del Estado de Mexico
Outcome results
None listed