An interventional study of Standardized therapeutic physical contact in Critical Illness and Critically Ill Patients, sponsored by Universidad Autonoma del Estado de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Universidad Autonoma del Estado de Mexico · Not applicable, Interventional, and Supportive care
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.
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 80 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Universidad Autonoma del Estado de Mexico is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient Criteria:
Primary Caregiver Criteria:
Exclusion Criteria
Patient Criteria:
Primary Caregiver Criteria:
- Unable to be present to perform the intervention according to the study protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Therapeutic physical contact provided by their primary caregiver
Other: Standardized therapeutic physical contact
Standard intensive care unit care without the standardized therapeutic physical contact intervention provided by the primary caregiver.
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.
Also known as: Physical contact
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.
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.
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.
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.
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.
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.
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.
Plan to share: Yes — 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning after publication of the primary study results with no predetermined end date.
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.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2026, 0 months after the start.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 0 months is below that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Autonoma del Estado de Mexico